Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2026-03-14 @ 6:01 PM
Study NCT ID:
NCT01990794
Status:
COMPLETED
Last Update Posted:
2014-10-06
First Post:
2013-11-12
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
90-Day Cobalt Supplementation Study to Investigate the Cobalt Body Burden in Ten Healthy Adult Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013959', 'term': 'Thyroid Diseases'}], 'ancestors': [{'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'david.galbraith@cardno.com', 'phone': '415-618-3211', 'title': 'Dr. David Galbraith', 'organization': 'Cardno'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'The primary limitation of our study was its small sample size. We believe the study was sufficiently robust because we evaluated effects on hematologic and thyroid variables, both of which have been identified as sensitive markers of cobalt exposure.'}}, 'adverseEventsModule': {'timeFrame': 'During the study: 7-8 months (approximate length of the study)', 'description': 'Summary of self-reported adverse events', 'eventGroups': [{'id': 'EG000', 'title': 'Study Volunteers', 'description': 'Study volunteers (males and females) were instructed to take the cobalt dietary supplement in the morning according to the manufacturer\'s label, which suggested a serving of 1 mg cobalt (\\~2 mL) daily "in water or juice as maintenance." Dietary supplementation lasted for approximately three months.', 'otherNumAtRisk': 13, 'otherNumAffected': 4, 'seriousNumAtRisk': 13, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Ear pain and tinnitus associated with sinusitis', 'notes': 'The tinnitus persisted in the right ear throughout the remainder of the study and post-dosing period, but did not impact daily activities. At two months post-dosing, the volunteer still reported mild tinnitus on the side of his prior infection.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Migraine headaches with prior history of headache', 'notes': 'The volunteer had a history of migraine headaches, and developed worsening headaches one week after starting to take the Co dietary supplement.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Vesicular rash following vaccination', 'notes': 'The volunteer had recently received a tetanus vaccination, as well as other vaccinations for yellow fever and typhoid near the time of the rash development', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Rash on face, neck, upper trunk, and back with peeling skin on palms of hands on both sides', 'notes': 'Study leaders were notified approximately 72 hours after the rash first developed, and some of her symptoms had resolved by the time she was assessed by the study director. Her skin changes gradually resolved about a month after she stopped taking Co', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'SECONDARY', 'title': 'Albumin Bound Cobalt Fraction in Serum', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Albumin-Co Fraction', 'description': 'Summary of albumin-Co fraction (SEC large molecular Co fraction) in 12 volunteers participating in the cobalt supplementation study. The average for each volunteer is based on 2 to 11 blood draws during dosing.'}], 'classes': [{'title': 'Subject 1', 'categories': [{'measurements': [{'value': '94.5', 'spread': '4.9', 'groupId': 'OG000'}]}]}, {'title': 'Subject 2', 'categories': [{'measurements': [{'value': '95.2', 'spread': '3.4', 'groupId': 'OG000'}]}]}, {'title': 'Subject 3', 'categories': [{'measurements': [{'value': '96.5', 'spread': '2.9', 'groupId': 'OG000'}]}]}, {'title': 'Subject 4', 'categories': [{'measurements': [{'value': '93.2', 'spread': '2.9', 'groupId': 'OG000'}]}]}, {'title': 'Subject 5', 'categories': [{'measurements': [{'value': '96.7', 'spread': '2.7', 'groupId': 'OG000'}]}]}, {'title': 'Subject 6', 'categories': [{'measurements': [{'value': '95.6', 'spread': '4.1', 'groupId': 'OG000'}]}]}, {'title': 'Subject 7', 'categories': [{'measurements': [{'value': '95.8', 'spread': '2.5', 'groupId': 'OG000'}]}]}, {'title': 'Subject 8', 'categories': [{'measurements': [{'value': '95.7', 'spread': '2.3', 'groupId': 'OG000'}]}]}, {'title': 'Subject 9', 'categories': [{'measurements': [{'value': '98.2', 'spread': '2.7', 'groupId': 'OG000'}]}]}, {'title': 'Subject 10', 'categories': [{'measurements': [{'value': '94.9', 'spread': '3.2', 'groupId': 'OG000'}]}]}, {'title': 'Subject 11', 'categories': [{'measurements': [{'value': '95.9', 'spread': '2.9', 'groupId': 'OG000'}]}]}, {'title': 'Subject 12', 'categories': [{'measurements': [{'value': '96.7', 'spread': '1.0', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Study volunteers will be followed for the duration of the study, an average of about 8 months for most volunteers', 'description': 'The fraction of albumin bound cobalt in serum was determined one to two weeks pre-dosing and on the day of the first dose before taking the supplement. Samples were also analyzed during the dosing period as follows: Day 4/5, Day 8/9, Day 14/16, Day 22/23, Day 29/30, Day 43/44, Day 57/58, Day 71/72, Day 88/90 and the fraction of albumin bound cobalt in serum was also determined at one and two weeks post-dosing.', 'unitOfMeasure': 'percentage of total blood cobalt', 'dispersionType': 'Standard Deviation', 'populationDescription': 'Analysis was carried out on the first 12 participants of the study'}, {'type': 'SECONDARY', 'title': 'Effects on the Immune System', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SI Before Cobalt Supplementation', 'description': 'Volunteers (males and females) were instructed to take the cobalt dietary supplement in the morning according to the manufacturer\'s label, which suggested a serving of 1 mg cobalt (\\~2 mL) daily "in water or juice as maintenance." Dietary supplementation lasted for approximately three months. Metal sensitivity to metals was assessed before and after cobalt dosing by using an in vitro lymphocyte transformation test (LTT).'}, {'id': 'OG001', 'title': 'SI After Cobalt Supplementation', 'description': 'Volunteers (males and females) were instructed to take the cobalt dietary supplement in the morning according to the manufacturer\'s label, which suggested a serving of 1 mg cobalt (\\~2 mL) daily "in water or juice as maintenance." Dietary supplementation lasted for approximately three months. Metal sensitivity to metals was assessed before and after cobalt dosing by using an in vitro lymphocyte transformation test (LTT).'}], 'classes': [{'title': 'Normalized lymphocyte transformation response: Al', 'categories': [{'measurements': [{'value': '1.79', 'spread': '1.77', 'groupId': 'OG000'}, {'value': '2.34', 'spread': '3.0', 'groupId': 'OG001'}]}]}, {'title': 'Normalized lymphocyte transformation response: Co', 'categories': [{'measurements': [{'value': '1.05', 'spread': '0.32', 'groupId': 'OG000'}, {'value': '1.44', 'spread': '0.72', 'groupId': 'OG001'}]}]}, {'title': 'Normalized lymphocyte transformation response: Cr', 'categories': [{'measurements': [{'value': '1.01', 'spread': '0.38', 'groupId': 'OG000'}, {'value': '1.43', 'spread': '0.46', 'groupId': 'OG001'}]}]}, {'title': 'Normalized lymphocyte transformation response: Mo', 'categories': [{'measurements': [{'value': '1.23', 'spread': '1.21', 'groupId': 'OG000'}, {'value': '2.31', 'spread': '1.17', 'groupId': 'OG001'}]}]}, {'title': 'Normalized lymphocyte transformation response: Ni', 'categories': [{'measurements': [{'value': '4.21', 'spread': '3.62', 'groupId': 'OG000'}, {'value': '4.32', 'spread': '3.0', 'groupId': 'OG001'}]}]}, {'title': 'Normalized lymphocyte transformation response: V', 'categories': [{'measurements': [{'value': '1.63', 'spread': '0.82', 'groupId': 'OG000'}, {'value': '1.86', 'spread': '0.79', 'groupId': 'OG001'}]}]}, {'title': 'Normalized lymphocyte transformation response: Zr', 'categories': [{'measurements': [{'value': '1.43', 'spread': '0.56', 'groupId': 'OG000'}, {'value': '1.41', 'spread': '0.87', 'groupId': 'OG001'}]}]}, {'title': 'Normalized lymphocyte transformation response: Fe', 'categories': [{'measurements': [{'value': '1.47', 'spread': '0.91', 'groupId': 'OG000'}, {'value': '1.82', 'spread': '1.62', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0 weeks and three months', 'description': 'Sensitivity to metals before and after cobalt supplementation was assessed by an in vitro lymphocyte transformation test (LTT) performed at week 0 and after three months of cobalt supplementation. The average proliferation rate for each metal treatment was normalized to individual proliferation rates of untreated control cells which generated a stimulation index (SI). According to the manufacture, the SI ranges from 0-15, with an SI from 2 to 4 indicated mild reactivity, from 5 to 8 indicated moderate reactivity, and \\>8 indicated high reactivity to the metal. The data is presented as the averaged normalized lymphocyte transformation response to each metal in men and women combined (n = 10).', 'unitOfMeasure': 'units on a scale: stimulation index (SI)', 'dispersionType': 'Standard Deviation', 'populationDescription': 'Participants that completed three months of cobalt supplementation'}, {'type': 'SECONDARY', 'title': 'Hemoglobin Levels After 1, 2 and 3 Months of Dosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Female Hgb', 'description': 'Hgb levels before, during and after dosing'}, {'id': 'OG001', 'title': 'Male Hgb', 'description': 'Hgb levels before, during, and after dosing'}], 'classes': [{'title': 'Baseline (n = 5, 5)', 'categories': [{'measurements': [{'value': '13.5', 'spread': '0.43', 'groupId': 'OG000'}, {'value': '14.9', 'spread': '0.93', 'groupId': 'OG001'}]}]}, {'title': 'Days 29 and 30 (n = 5, 5)', 'categories': [{'measurements': [{'value': '13.3', 'spread': '0.50', 'groupId': 'OG000'}, {'value': '14.8', 'spread': '0.82', 'groupId': 'OG001'}]}]}, {'title': 'Days 57 and 58 (n = 5, 5)', 'categories': [{'measurements': [{'value': '13.2', 'spread': '0.37', 'groupId': 'OG000'}, {'value': '15.1', 'spread': '0.74', 'groupId': 'OG001'}]}]}, {'title': 'Days 88 and 90 (n = 5, 5)', 'categories': [{'measurements': [{'value': '13.1', 'spread': '0.31', 'groupId': 'OG000'}, {'value': '14.9', 'spread': '0.76', 'groupId': 'OG001'}]}]}, {'title': '1 wk postdose (n = 5, 5)', 'categories': [{'measurements': [{'value': '13.4', 'spread': '0.75', 'groupId': 'OG000'}, {'value': '14.9', 'spread': '0.78', 'groupId': 'OG001'}]}]}, {'title': '2 wk postdose (n = 5, 5)', 'categories': [{'measurements': [{'value': '13.1', 'spread': '0.61', 'groupId': 'OG000'}, {'value': '15.0', 'spread': '0.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Study volunteers were assessed before, during and after cobalt supplementation (2 wk post)', 'description': 'Blood chemistries assessed during the study included a lipid panel, comprehensive metabolic panel, creatine kinase-myocardial band, thyroid stimulating hormone, free thyroxine, and complete blood count with differential, total iron, and ferritin. Blood chemistries were assessed at one or two week pre-dose, pre-dose/ Day 1 before taking the supplement, Day 29/30, Day 57/58, Day 88/90 and one and two weeks post-dose.', 'unitOfMeasure': 'g/dL', 'dispersionType': 'Standard Deviation', 'populationDescription': 'Participants that completed three months of cobalt supplementation. Individual baseline values for the 1-wk predose draw and the day 1 (predose) draw were averaged together to give one baseline value.'}, {'type': 'SECONDARY', 'title': 'Changes in Audiological Function', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Baseline - Left', 'description': 'Comparison of hearing function in volunteers before, during, and after cobalt supplementation'}, {'id': 'OG001', 'title': 'Baseline - Right', 'description': 'Comparison of hearing function in volunteers before, during, and after cobalt supplementation'}, {'id': 'OG002', 'title': 'Study Midpoint - Left', 'description': 'Comparison of hearing function in volunteers before, during, and after cobalt supplementation'}, {'id': 'OG003', 'title': 'Study Midpoint - Right', 'description': 'Comparison of hearing function in volunteers before, during, and after cobalt supplementation'}, {'id': 'OG004', 'title': 'Study Completion - Left', 'description': 'Comparison of hearing function in volunteers before, during, and after cobalt supplementation'}, {'id': 'OG005', 'title': 'Study Completion - Right', 'description': 'Comparison of hearing function in volunteers before, during, and after cobalt supplementation'}], 'classes': [{'title': '250 Hz', 'categories': [{'measurements': [{'value': '10.0', 'spread': '4.7', 'groupId': 'OG000'}, {'value': '8.0', 'spread': '6.3', 'groupId': 'OG001'}, {'value': '9.0', 'spread': '3.9', 'groupId': 'OG002'}, {'value': '8.0', 'spread': '6.7', 'groupId': 'OG003'}, {'value': '7.5', 'spread': '3.5', 'groupId': 'OG004'}, {'value': '6.0', 'spread': '5.7', 'groupId': 'OG005'}]}]}, {'title': '500 Hz', 'categories': [{'measurements': [{'value': '10.0', 'spread': '4.1', 'groupId': 'OG000'}, {'value': '6.0', 'spread': '6.1', 'groupId': 'OG001'}, {'value': '8.5', 'spread': '4.7', 'groupId': 'OG002'}, {'value': '7.5', 'spread': '6.8', 'groupId': 'OG003'}, {'value': '6.5', 'spread': '4.7', 'groupId': 'OG004'}, {'value': '5.5', 'spread': '5.0', 'groupId': 'OG005'}]}]}, {'title': '1000 Hz', 'categories': [{'measurements': [{'value': '9.0', 'spread': '3.2', 'groupId': 'OG000'}, {'value': '7.5', 'spread': '2.6', 'groupId': 'OG001'}, {'value': '6.5', 'spread': '4.1', 'groupId': 'OG002'}, {'value': '5.0', 'spread': '4.1', 'groupId': 'OG003'}, {'value': '6.5', 'spread': '4.7', 'groupId': 'OG004'}, {'value': '7.5', 'spread': '4.2', 'groupId': 'OG005'}]}]}, {'title': '2000 Hz', 'categories': [{'measurements': [{'value': '9.0', 'spread': '5.7', 'groupId': 'OG000'}, {'value': '9.5', 'spread': '4.4', 'groupId': 'OG001'}, {'value': '8.5', 'spread': '6.7', 'groupId': 'OG002'}, {'value': '9.5', 'spread': '6.0', 'groupId': 'OG003'}, {'value': '7.0', 'spread': '6.8', 'groupId': 'OG004'}, {'value': '7.5', 'spread': '6.3', 'groupId': 'OG005'}]}]}, {'title': '3000 Hz', 'categories': [{'measurements': [{'value': '7.0', 'spread': '7.5', 'groupId': 'OG000'}, {'value': '8.5', 'spread': '4.7', 'groupId': 'OG001'}, {'value': '7.5', 'spread': '6.8', 'groupId': 'OG002'}, {'value': '8.0', 'spread': '4.2', 'groupId': 'OG003'}, {'value': '8.0', 'spread': '7.5', 'groupId': 'OG004'}, {'value': '5.0', 'spread': '3.3', 'groupId': 'OG005'}]}]}, {'title': '4000 Hz', 'categories': [{'measurements': [{'value': '10.5', 'spread': '9.0', 'groupId': 'OG000'}, {'value': '6.0', 'spread': '5.7', 'groupId': 'OG001'}, {'value': '9.5', 'spread': '10.1', 'groupId': 'OG002'}, {'value': '6.0', 'spread': '5.2', 'groupId': 'OG003'}, {'value': '8.5', 'spread': '10.5', 'groupId': 'OG004'}, {'value': '7.5', 'spread': '5.4', 'groupId': 'OG005'}]}]}, {'title': '6000 Hz', 'categories': [{'measurements': [{'value': '10.0', 'spread': '8.5', 'groupId': 'OG000'}, {'value': '12.0', 'spread': '8.9', 'groupId': 'OG001'}, {'value': '11.0', 'spread': '9.1', 'groupId': 'OG002'}, {'value': '11.0', 'spread': '9.9', 'groupId': 'OG003'}, {'value': '9.0', 'spread': '6.9', 'groupId': 'OG004'}, {'value': '10.0', 'spread': '9.7', 'groupId': 'OG005'}]}]}, {'title': '8000 Hz', 'categories': [{'measurements': [{'value': '5.5', 'spread': '7.6', 'groupId': 'OG000'}, {'value': '10.0', 'spread': '7.8', 'groupId': 'OG001'}, {'value': '8.5', 'spread': '8.8', 'groupId': 'OG002'}, {'value': '7.5', 'spread': '7.2', 'groupId': 'OG003'}, {'value': '9.0', 'spread': '7.1', 'groupId': 'OG004'}, {'value': '7.5', 'spread': '5.4', 'groupId': 'OG005'}]}]}, {'title': '12,000 Hz', 'categories': [{'measurements': [{'value': '9.5', 'spread': '13.0', 'groupId': 'OG000'}, {'value': '7.5', 'spread': '10.1', 'groupId': 'OG001'}, {'value': '8.5', 'spread': '11.8', 'groupId': 'OG002'}, {'value': '9.0', 'spread': '8.1', 'groupId': 'OG003'}, {'value': '9.5', 'spread': '12.4', 'groupId': 'OG004'}, {'value': '8.0', 'spread': '7.9', 'groupId': 'OG005'}]}]}, {'title': '16,000 Hz', 'categories': [{'measurements': [{'value': '24.0', 'spread': '21.2', 'groupId': 'OG000'}, {'value': '25.5', 'spread': '24.9', 'groupId': 'OG001'}, {'value': '21.0', 'spread': '22.6', 'groupId': 'OG002'}, {'value': '25.0', 'spread': '24.7', 'groupId': 'OG003'}, {'value': '22.0', 'spread': '20.0', 'groupId': 'OG004'}, {'value': '24.0', 'spread': '22.2', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, at the study midpoint, and at the study completion', 'description': 'Audiologic assessments including pure tone threshold determination at frequencies ranging from 250 to 16000 Hz were performed with volunteers serving as their own baseline controls for receptive changes during the study (i.e., week 0, \\~day 45, \\~day 90). Audiologic assessments including a pure-tone threshold determination at frequencies that ranged from 250 to 16000 Hz were performed with volunteers serving as their own baseline controls for receptive changes during the study. Decreases in hearing were considered clinically significant when one of the following 3 American Speech-Language-Hearing Association criteria were met: 1) a ≥20-dB decrease in the pure-tone threshold at one test frequency, 2) a ≥10-dB decrease at 2 adjacent test frequencies, or 3) the loss of 3 consecutive test frequencies where responses were previously obtained.', 'unitOfMeasure': 'dB', 'dispersionType': 'Standard Deviation', 'populationDescription': 'Participants that completed three months of cobalt supplementation'}, {'type': 'SECONDARY', 'title': 'Changes in Cardiac Function', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Prestudy', 'description': 'Comparison of left and right ventricular function in volunteers before and after cobalt supplementation'}, {'id': 'OG001', 'title': 'Study Midpoint', 'description': 'Comparison of left and right ventricular function in volunteers before and after cobalt supplementation'}, {'id': 'OG002', 'title': 'Study Completion', 'description': 'Comparison of left and right ventricular function in volunteers before and after cobalt supplementation'}], 'classes': [{'title': 'LVID (ed) (cm)', 'categories': [{'measurements': [{'value': '4.77', 'spread': '0.52', 'groupId': 'OG000'}, {'value': '4.75', 'spread': '0.55', 'groupId': 'OG001'}, {'value': '4.65', 'spread': '0.44', 'groupId': 'OG002'}]}]}, {'title': 'LVID (es) (cm)', 'categories': [{'measurements': [{'value': '3.15', 'spread': '0.38', 'groupId': 'OG000'}, {'value': '2.97', 'spread': '0.49', 'groupId': 'OG001'}, {'value': '2.95', 'spread': '0.55', 'groupId': 'OG002'}]}]}, {'title': 'RVID (ed) (cm)', 'categories': [{'measurements': [{'value': '2.08', 'spread': '0.46', 'groupId': 'OG000'}, {'value': '2.02', 'spread': '0.38', 'groupId': 'OG001'}, {'value': '2.16', 'spread': '0.35', 'groupId': 'OG002'}]}]}, {'title': 'Ao Root (ed) (cm)', 'categories': [{'measurements': [{'value': '2.99', 'spread': '0.38', 'groupId': 'OG000'}, {'value': '3.03', 'spread': '0.45', 'groupId': 'OG001'}, {'value': '3.01', 'spread': '0.44', 'groupId': 'OG002'}]}]}, {'title': 'IVS (ed) (cm)', 'categories': [{'measurements': [{'value': '1.07', 'spread': '0.19', 'groupId': 'OG000'}, {'value': '1.06', 'spread': '0.22', 'groupId': 'OG001'}, {'value': '1.05', 'spread': '0.13', 'groupId': 'OG002'}]}]}, {'title': 'IVS (es) (cm)', 'categories': [{'measurements': [{'value': '1.40', 'spread': '0.24', 'groupId': 'OG000'}, {'value': '1.46', 'spread': '0.24', 'groupId': 'OG001'}, {'value': '1.48', 'spread': '0.24', 'groupId': 'OG002'}]}]}, {'title': 'LVPWs (ed) (cm)', 'categories': [{'measurements': [{'value': '0.94', 'spread': '0.12', 'groupId': 'OG000'}, {'value': '0.95', 'spread': '0.11', 'groupId': 'OG001'}, {'value': '0.99', 'spread': '0.13', 'groupId': 'OG002'}]}]}, {'title': 'LVPWs (es) (cm)', 'categories': [{'measurements': [{'value': '1.49', 'spread': '0.19', 'groupId': 'OG000'}, {'value': '1.47', 'spread': '0.18', 'groupId': 'OG001'}, {'value': '1.52', 'spread': '0.15', 'groupId': 'OG002'}]}]}, {'title': 'LA (es) (cm)', 'categories': [{'measurements': [{'value': '3.15', 'spread': '0.21', 'groupId': 'OG000'}, {'value': '3.34', 'spread': '0.34', 'groupId': 'OG001'}, {'value': '3.13', 'spread': '0.44', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, at the study midpoint, and at the study completion', 'description': 'Two-dimensional and Doppler echocardiographic examinations were used to assess cardiac anatomy, structure, and function during the study with volunteers serving as their own baseline controls for changes during the study (i.e., week 0, \\~day 45, \\~day 90).', 'unitOfMeasure': 'cm', 'dispersionType': 'Standard Deviation', 'populationDescription': 'Participants that completed three months of cobalt supplementation'}, {'type': 'SECONDARY', 'title': 'Changes in Visual Function', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Prestudy - Right', 'description': 'Values of the right eye for select ONH variables'}, {'id': 'OG001', 'title': 'Prestudy - Left', 'description': 'Values of the left eye for select ONH variables'}, {'id': 'OG002', 'title': 'Study Midpoint - Right', 'description': 'Values of the right eye for select ONH variables'}, {'id': 'OG003', 'title': 'Study Midpoint - Left', 'description': 'Values of the left eye for select ONH variables'}, {'id': 'OG004', 'title': 'Study Completion - Right', 'description': 'Values of the right eye for select ONH variables'}, {'id': 'OG005', 'title': 'Study Completion - Left', 'description': 'Values of the left eye for select ONH variables'}], 'classes': [{'title': 'Rim area (mm^2)', 'categories': [{'measurements': [{'value': '1.29', 'spread': '0.23', 'groupId': 'OG000'}, {'value': '1.35', 'spread': '0.23', 'groupId': 'OG001'}, {'value': '1.38', 'spread': '0.23', 'groupId': 'OG002'}, {'value': '1.39', 'spread': '0.29', 'groupId': 'OG003'}, {'value': '1.31', 'spread': '0.19', 'groupId': 'OG004'}, {'value': '1.36', 'spread': '0.25', 'groupId': 'OG005'}]}]}, {'title': 'Disc Area (mm^2)', 'categories': [{'measurements': [{'value': '1.65', 'spread': '0.30', 'groupId': 'OG000'}, {'value': '1.73', 'spread': '0.31', 'groupId': 'OG001'}, {'value': '1.71', 'spread': '0.33', 'groupId': 'OG002'}, {'value': '1.74', 'spread': '0.42', 'groupId': 'OG003'}, {'value': '1.59', 'spread': '0.20', 'groupId': 'OG004'}, {'value': '1.63', 'spread': '0.27', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, at the study midpoint, and at the study completion', 'description': 'Ophthalmology studies included an assessment of visual acuity, slit lamp evaluations, and visual field testing. Retinal nerve fiber layer (RNFL) thickness and optic nerve head (ONH) were assessed using optical coherence tomography (OCT). Volunteers served as their own baseline controls for changes during the study (i.e., week 0, \\~day 45, \\~day 90).', 'unitOfMeasure': 'mm^2', 'dispersionType': 'Standard Deviation', 'populationDescription': 'Participants that completed three months of cobalt supplementation'}, {'type': 'SECONDARY', 'title': 'Changes in Neurological Function (Peroneal Motor Amplitude)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Prestudy', 'description': 'Values of the sural sensory and peroneal motor variables'}, {'id': 'OG001', 'title': 'Study Midpoint', 'description': 'Values of the sural sensory and peroneal motor variables'}, {'id': 'OG002', 'title': 'Study Completion', 'description': 'Values of the sural sensory and peroneal motor variables'}], 'classes': [{'categories': [{'measurements': [{'value': '5.1', 'spread': '2.3', 'groupId': 'OG000'}, {'value': '5.5', 'spread': '2.3', 'groupId': 'OG001'}, {'value': '5.6', 'spread': '3.0', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, at the study midpoint, and at the study completion', 'description': 'Values of the sural sensory and peroneal motor variables. Volunteers served as their own baseline controls for changes during the study (i.e., week 0, \\~day 45, \\~day 90, and \\~4-6 post-weeks).', 'unitOfMeasure': 'Peroneal Motor Amplitude (mV)', 'dispersionType': 'Standard Deviation', 'populationDescription': 'Participants that completed three months of cobalt supplementation'}, {'type': 'PRIMARY', 'title': 'Cobalt Whole Blood Concentrations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Female', 'description': 'Volunteers (males and females) were instructed to take the cobalt dietary supplement in the morning according to the manufacturer\'s label, which suggested a serving of 1 mg cobalt (\\~2 mL) daily "in water or juice as maintenance." Dietary supplementation lasted for approximately three months.'}, {'id': 'OG001', 'title': 'Male', 'description': 'Volunteers (males and females) were instructed to take the cobalt dietary supplement in the morning according to the manufacturer\'s label, which suggested a serving of 1 mg cobalt (\\~2 mL) daily "in water or juice as maintenance." Dietary supplementation lasted for approximately three months.'}], 'classes': [{'title': 'Day 4/5', 'categories': [{'measurements': [{'value': '14.6', 'spread': '8.2', 'groupId': 'OG000'}, {'value': '7.4', 'spread': '3.6', 'groupId': 'OG001'}]}]}, {'title': 'Day 8/9', 'categories': [{'measurements': [{'value': '33.9', 'spread': '24.0', 'groupId': 'OG000'}, {'value': '8.5', 'spread': '6.9', 'groupId': 'OG001'}]}]}, {'title': 'Day 14/16', 'categories': [{'measurements': [{'value': '29.9', 'spread': '22.0', 'groupId': 'OG000'}, {'value': '13.8', 'spread': '6.4', 'groupId': 'OG001'}]}]}, {'title': 'Day 22/23', 'categories': [{'measurements': [{'value': '25.6', 'spread': '17.8', 'groupId': 'OG000'}, {'value': '18.7', 'spread': '11.3', 'groupId': 'OG001'}]}]}, {'title': 'Day 29/30', 'categories': [{'measurements': [{'value': '37.1', 'spread': '24.8', 'groupId': 'OG000'}, {'value': '19.3', 'spread': '7.9', 'groupId': 'OG001'}]}]}, {'title': 'Day 43/44', 'categories': [{'measurements': [{'value': '35.9', 'spread': '27.1', 'groupId': 'OG000'}, {'value': '18.5', 'spread': '10.5', 'groupId': 'OG001'}]}]}, {'title': 'Day 57/58', 'categories': [{'measurements': [{'value': '40.7', 'spread': '28.1', 'groupId': 'OG000'}, {'value': '20.3', 'spread': '11.1', 'groupId': 'OG001'}]}]}, {'title': 'Day 71/72', 'categories': [{'measurements': [{'value': '37.1', 'spread': '33.7', 'groupId': 'OG000'}, {'value': '22.1', 'spread': '11.5', 'groupId': 'OG001'}]}]}, {'title': 'Day 88/90', 'categories': [{'measurements': [{'value': '53.3', 'spread': '45.3', 'groupId': 'OG000'}, {'value': '20.4', 'spread': '8.5', 'groupId': 'OG001'}]}]}, {'title': '1 wk post', 'categories': [{'measurements': [{'value': '22.2', 'spread': '19.3', 'groupId': 'OG000'}, {'value': '12.0', 'spread': '6.3', 'groupId': 'OG001'}]}]}, {'title': '2 wk post', 'categories': [{'measurements': [{'value': '15.9', 'spread': '13.3', 'groupId': 'OG000'}, {'value': '8.7', 'spread': '4.1', 'groupId': 'OG001'}]}]}, {'title': '6 wk post', 'categories': [{'measurements': [{'value': '9.7', 'spread': '7.9', 'groupId': 'OG000'}, {'value': '5.6', 'spread': '2.9', 'groupId': 'OG001'}]}]}, {'title': '10 wk post', 'categories': [{'measurements': [{'value': '5.9', 'spread': '5.4', 'groupId': 'OG000'}, {'value': '3.9', 'spread': '2.5', 'groupId': 'OG001'}]}]}, {'title': '16 wk post', 'categories': [{'measurements': [{'value': '1.1', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '0.7', 'spread': '0.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Before, during and after cobalt supplementation', 'description': 'The cobalt concentration in whole blood and serum was determined one to two weeks pre-dosing and on the day of the first day of dosing before taking the supplement. Samples were also analyzed during the dosing period as follows: Day 4/5, Day 8/9, Day 14/16, Day 22/23, Day 29/30, Day 43/44, Day 57/58, Day 71/72, and Day 88/90. Cobalt concentration in whole blood and serum was also determined at one, two, six, ten and 16 weeks post-dosing.', 'unitOfMeasure': 'µg Co/L', 'dispersionType': 'Standard Deviation', 'populationDescription': 'Participants that completed three months of cobalt supplementation'}, {'type': 'SECONDARY', 'title': 'White Blood Cell (WBC) Levels After 1, 2 and 3 Months of Cobalt Dietary Supplementation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Female WBC', 'description': 'WBC levels before, during and after dosing'}, {'id': 'OG001', 'title': 'Male WBC', 'description': 'WBC levels before, during, and after dosing'}], 'classes': [{'title': 'Baseline (n = 5, 5)', 'categories': [{'measurements': [{'value': '6.46', 'spread': '0.94', 'groupId': 'OG000'}, {'value': '6.79', 'spread': '1.12', 'groupId': 'OG001'}]}]}, {'title': 'Days 29 and 30 (n = 5, 5)', 'categories': [{'measurements': [{'value': '6.44', 'spread': '1.09', 'groupId': 'OG000'}, {'value': '6.42', 'spread': '0.79', 'groupId': 'OG001'}]}]}, {'title': 'Days 57 and 58 (n = 5, 5)', 'categories': [{'measurements': [{'value': '6.36', 'spread': '0.88', 'groupId': 'OG000'}, {'value': '6.94', 'spread': '0.94', 'groupId': 'OG001'}]}]}, {'title': 'Days 88 and 90 (n = 5, 5)', 'categories': [{'measurements': [{'value': '5.98', 'spread': '1.24', 'groupId': 'OG000'}, {'value': '6.34', 'spread': '0.75', 'groupId': 'OG001'}]}]}, {'title': '1 wk postdose (n = 5, 5)', 'categories': [{'measurements': [{'value': '6.1', 'spread': '1.51', 'groupId': 'OG000'}, {'value': '7.1', 'spread': '1.78', 'groupId': 'OG001'}]}]}, {'title': '2 wk postdose (n = 5, 5)', 'categories': [{'measurements': [{'value': '6.34', 'spread': '0.92', 'groupId': 'OG000'}, {'value': '6.42', 'spread': '0.46', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Study volunteers were assessed before, during and after cobalt supplementation (2 wk post)', 'description': 'Blood chemistries assessed during the study included a lipid panel, comprehensive metabolic panel, creatine kinase-myocardial band, thyroid stimulating hormone, free thyroxine, and complete blood count with differential, total iron, and ferritin. Blood chemistries were assessed at one or two week pre-dose, pre-dose/ Day 1 before taking the supplement, Day 29/30, Day 57/58, Day 88/90 and one and two weeks post-dose.', 'unitOfMeasure': 'thousand cells/µL', 'dispersionType': 'Standard Deviation', 'populationDescription': 'Participants that completed three months of cobalt supplementation. Individual baseline values for the 1-wk predose draw and the day 1 (predose) draw were averaged together to give one baseline value.'}, {'type': 'SECONDARY', 'title': 'Red Blood Cell (RBC) Levels After 1, 2 and 3 Months of Dosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Female RBC', 'description': 'RBC levels before, during and after dosing'}, {'id': 'OG001', 'title': 'Male RBC', 'description': 'RBC levels before, during, and after dosing'}], 'classes': [{'title': 'Baseline (n = 5, 5)', 'categories': [{'measurements': [{'value': '4.42', 'spread': '0.28', 'groupId': 'OG000'}, {'value': '4.71', 'spread': '0.2', 'groupId': 'OG001'}]}]}, {'title': 'Days 29 and 30 (n = 5, 5)', 'categories': [{'measurements': [{'value': '4.28', 'spread': '0.18', 'groupId': 'OG000'}, {'value': '4.70', 'spread': '0.20', 'groupId': 'OG001'}]}]}, {'title': 'Days 57 and 58 (n = 5, 5)', 'categories': [{'measurements': [{'value': '4.3', 'spread': '0.21', 'groupId': 'OG000'}, {'value': '4.81', 'spread': '0.18', 'groupId': 'OG001'}]}]}, {'title': 'Days 88 and 90 (n = 5, 5)', 'categories': [{'measurements': [{'value': '4.32', 'spread': '0.27', 'groupId': 'OG000'}, {'value': '4.72', 'spread': '0.32', 'groupId': 'OG001'}]}]}, {'title': '1 wk postdose (n = 5, 5)', 'categories': [{'measurements': [{'value': '4.42', 'spread': '0.37', 'groupId': 'OG000'}, {'value': '4.77', 'spread': '0.24', 'groupId': 'OG001'}]}]}, {'title': '2 wk postdose (n = 5, 5)', 'categories': [{'measurements': [{'value': '4.38', 'spread': '0.31', 'groupId': 'OG000'}, {'value': '4.79', 'spread': '0.21', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Study volunteers were assessed before, during and after cobalt supplementation (2 wk post)', 'description': 'Blood chemistries assessed during the study included a lipid panel, comprehensive metabolic panel, creatine kinase-myocardial band, thyroid stimulating hormone, free thyroxine, and complete blood count with differential, total iron, and ferritin. Blood chemistries were assessed at one or two week pre-dose, pre-dose/ Day 1 before taking the supplement, Day 29/30, Day 57/58, Day 88/90 and one and two weeks post-dose.', 'unitOfMeasure': 'million cells/µL', 'dispersionType': 'Standard Deviation', 'populationDescription': 'Participants that completed three months of cobalt supplementation. Individual male baseline values for the 1-wk predose draw and the day 1 (predose) draw were averaged together. For females, the average baseline is the 1-wk predose data only because there was a significant difference between the 1-wk predose draw and the day 1 (predose) draw.'}, {'type': 'SECONDARY', 'title': 'Hematocrit Levels After 1, 2 and 3 Months of Dosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Female Hematocrit', 'description': 'Hematocrit levels before, during and after dosing'}, {'id': 'OG001', 'title': 'Male Hematocrit', 'description': 'Hematocrit levels before, during, and after dosing'}], 'classes': [{'title': 'Baseline (n = 5, 5)', 'categories': [{'measurements': [{'value': '41.5', 'spread': '1.68', 'groupId': 'OG000'}, {'value': '45.1', 'spread': '2.53', 'groupId': 'OG001'}]}]}, {'title': 'Days 29 and 30 (n = 5, 5)', 'categories': [{'measurements': [{'value': '40.9', 'spread': '1.15', 'groupId': 'OG000'}, {'value': '45.0', 'spread': '2.54', 'groupId': 'OG001'}]}]}, {'title': 'Days 57 and 58 (n = 5, 5)', 'categories': [{'measurements': [{'value': '41.0', 'spread': '1.14', 'groupId': 'OG000'}, {'value': '46.3', 'spread': '2.75', 'groupId': 'OG001'}]}]}, {'title': 'Days 88 and 90 (n = 5, 5)', 'categories': [{'measurements': [{'value': '40.9', 'spread': '2.00', 'groupId': 'OG000'}, {'value': '45.0', 'spread': '2.9', 'groupId': 'OG001'}]}]}, {'title': '1 wk postdose (n = 5, 5)', 'categories': [{'measurements': [{'value': '41.7', 'spread': '2.17', 'groupId': 'OG000'}, {'value': '45.8', 'spread': '2.39', 'groupId': 'OG001'}]}]}, {'title': '2 wk postdose (n = 5, 5)', 'categories': [{'measurements': [{'value': '40.9', 'spread': '2.42', 'groupId': 'OG000'}, {'value': '45.7', 'spread': '1.11', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Study volunteers were assessed before, during and after cobalt supplementation (2 wk post)', 'description': 'Blood chemistries assessed during the study included a lipid panel, comprehensive metabolic panel, creatine kinase-myocardial band, thyroid stimulating hormone, free thyroxine, and complete blood count with differential, total iron, and ferritin. Blood chemistries were assessed at one or two week pre-dose, pre-dose/ Day 1 before taking the supplement, Day 29/30, Day 57/58, Day 88/90 and one and two weeks post-dose.', 'unitOfMeasure': 'Percentage', 'dispersionType': 'Standard Deviation', 'populationDescription': 'Participants that completed three months of cobalt supplementation. Individual baseline values for the 1-wk predose draw and the day 1 (predose) draw were averaged together to give one baseline value.'}, {'type': 'SECONDARY', 'title': 'Protein Levels After 1, 2 and 3 Months of Dosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Female Protein', 'description': 'Protein levels before, during and after dosing'}, {'id': 'OG001', 'title': 'Male Protein', 'description': 'Protein levels before, during, and after dosing'}], 'classes': [{'title': 'Baseline (n = 5, 5)', 'categories': [{'measurements': [{'value': '7.11', 'spread': '0.33', 'groupId': 'OG000'}, {'value': '7.26', 'spread': '0.30', 'groupId': 'OG001'}]}]}, {'title': 'Days 29 and 30 (n = 5, 5)', 'categories': [{'measurements': [{'value': '7.00', 'spread': '0.35', 'groupId': 'OG000'}, {'value': '7.24', 'spread': '0.30', 'groupId': 'OG001'}]}]}, {'title': 'Days 57 and 58 (n = 5, 5)', 'categories': [{'measurements': [{'value': '7.08', 'spread': '0.28', 'groupId': 'OG000'}, {'value': '7.16', 'spread': '0.31', 'groupId': 'OG001'}]}]}, {'title': 'Days 88 and 90 (n = 5, 5)', 'categories': [{'measurements': [{'value': '7.02', 'spread': '0.38', 'groupId': 'OG000'}, {'value': '7.14', 'spread': '0.11', 'groupId': 'OG001'}]}]}, {'title': '1 wk postdose (n = 5, 5)', 'categories': [{'measurements': [{'value': '6.96', 'spread': '0.48', 'groupId': 'OG000'}, {'value': '7.28', 'spread': '0.33', 'groupId': 'OG001'}]}]}, {'title': '2 wk postdose (n =5, 5)', 'categories': [{'measurements': [{'value': '7.04', 'spread': '0.29', 'groupId': 'OG000'}, {'value': '7.32', 'spread': '0.41', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Study volunteers were assessed before, during and after cobalt supplementation (2 wk post)', 'description': 'Blood chemistries assessed during the study included a lipid panel, comprehensive metabolic panel, creatine kinase-myocardial band, thyroid stimulating hormone, free thyroxine, and complete blood count with differential, total iron, and ferritin. Blood chemistries were assessed at one or two week pre-dose, pre-dose/ Day 1 before taking the supplement, Day 29/30, Day 57/58, Day 88/90 and one and two weeks post-dose.', 'unitOfMeasure': 'g/dL', 'dispersionType': 'Standard Deviation', 'populationDescription': 'Participants that completed three months of cobalt supplementation. Individual baseline values for the 1-wk predose draw and the day 1 (predose) draw were averaged together to give one baseline value.'}, {'type': 'SECONDARY', 'title': 'Albumin Levels After 1, 2 and 3 Months of Dosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Female Albumin', 'description': 'Albumin levels before, during and after dosing'}, {'id': 'OG001', 'title': 'Male Albumin', 'description': 'Albumin levels before, during, and after dosing'}], 'classes': [{'title': 'Baseline (n = 5, 5)', 'categories': [{'measurements': [{'value': '4.39', 'spread': '0.22', 'groupId': 'OG000'}, {'value': '4.63', 'spread': '0.32', 'groupId': 'OG001'}]}]}, {'title': 'Days 29 and 30 (n = 5, 5)', 'categories': [{'measurements': [{'value': '4.32', 'spread': '0.16', 'groupId': 'OG000'}, {'value': '4.60', 'spread': '0.37', 'groupId': 'OG001'}]}]}, {'title': 'Days 57 and 58 (n = 5, 5)', 'categories': [{'measurements': [{'value': '4.34', 'spread': '0.17', 'groupId': 'OG000'}, {'value': '4.56', 'spread': '0.23', 'groupId': 'OG001'}]}]}, {'title': 'Days 88 and 90 (n = 5, 5)', 'categories': [{'measurements': [{'value': '4.28', 'spread': '0.19', 'groupId': 'OG000'}, {'value': '4.48', 'spread': '0.25', 'groupId': 'OG001'}]}]}, {'title': '1 wk postdose (n = 5, 5)', 'categories': [{'measurements': [{'value': '4.20', 'spread': '0.27', 'groupId': 'OG000'}, {'value': '4.60', 'spread': '0.3', 'groupId': 'OG001'}]}]}, {'title': '2 wk postdose (n = 5, 5)', 'categories': [{'measurements': [{'value': '4.32', 'spread': '0.25', 'groupId': 'OG000'}, {'value': '4.56', 'spread': '0.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Study volunteers were assessed before, during and after cobalt supplementation (2 wk post)', 'description': 'Blood chemistries assessed during the study included a lipid panel, comprehensive metabolic panel, creatine kinase-myocardial band, thyroid stimulating hormone, free thyroxine, and complete blood count with differential, total iron, and ferritin. Blood chemistries were assessed at one or two week pre-dose, pre-dose/ Day 1 before taking the supplement, Day 29/30, Day 57/58, Day 88/90 and one and two weeks post-dose.', 'unitOfMeasure': 'g/dL', 'dispersionType': 'Standard Deviation', 'populationDescription': 'Participants that completed three months of cobalt supplementation. Individual baseline values for the 1-wk predose draw and the day 1 (predose) draw were averaged together to give one baseline value.'}, {'type': 'SECONDARY', 'title': 'Thyroid-Stimulating Hormone (TSH) Levels After 1, 2 and 3 Months of Dosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Female TSH', 'description': 'TSH levels before, during and after dosing'}, {'id': 'OG001', 'title': 'Male TSH', 'description': 'TSH levels before, during, and after dosing'}], 'classes': [{'title': 'Baseline (n = 5, 5)', 'categories': [{'measurements': [{'value': '1.73', 'spread': '0.77', 'groupId': 'OG000'}, {'value': '2.35', 'spread': '1.72', 'groupId': 'OG001'}]}]}, {'title': 'Days 29 and 30 (n = 5, 5)', 'categories': [{'measurements': [{'value': '1.53', 'spread': '1.03', 'groupId': 'OG000'}, {'value': '3.35', 'spread': '3.82', 'groupId': 'OG001'}]}]}, {'title': 'Days 57 and 58 (n = 5, 5)', 'categories': [{'measurements': [{'value': '1.65', 'spread': '1.08', 'groupId': 'OG000'}, {'value': '3.11', 'spread': '3.65', 'groupId': 'OG001'}]}]}, {'title': 'Days 88 and 90 (n = 5, 5)', 'categories': [{'measurements': [{'value': '2.30', 'spread': '1.90', 'groupId': 'OG000'}, {'value': '2.24', 'spread': '2.02', 'groupId': 'OG001'}]}]}, {'title': '1 wk postdose (n = 5, 5)', 'categories': [{'measurements': [{'value': '1.73', 'spread': '0.90', 'groupId': 'OG000'}, {'value': '2.30', 'spread': '1.93', 'groupId': 'OG001'}]}]}, {'title': '2 wk postdose (n = 5, 5)', 'categories': [{'measurements': [{'value': '1.55', 'spread': '0.63', 'groupId': 'OG000'}, {'value': '2.33', 'spread': '2.35', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Study volunteers were assessed before, during and after cobalt supplementation (2 wk post)', 'description': 'Blood chemistries assessed during the study included a lipid panel, comprehensive metabolic panel, creatine kinase-myocardial band, thyroid stimulating hormone, free thyroxine, and complete blood count with differential, total iron, and ferritin. Blood chemistries were assessed at one or two week pre-dose, pre-dose/ Day 1 before taking the supplement, Day 29/30, Day 57/58, Day 88/90 and one and two weeks post-dose.', 'unitOfMeasure': 'mIU/L', 'dispersionType': 'Standard Deviation', 'populationDescription': 'Participants that completed three months of cobalt supplementation. Individual baseline values for the 1-wk predose draw and the day 1 (predose) draw were averaged together to give one baseline value.'}, {'type': 'SECONDARY', 'title': 'T4 Levels After 1, 2 and 3 Months of Dosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Female T4', 'description': 'T4 levels before, during and after dosing'}, {'id': 'OG001', 'title': 'Male T4', 'description': 'T4 levels before, during, and after dosing'}], 'classes': [{'title': 'Baseline (n = 5, 5)', 'categories': [{'measurements': [{'value': '1.10', 'spread': '0.11', 'groupId': 'OG000'}, {'value': '1.15', 'spread': '0.15', 'groupId': 'OG001'}]}]}, {'title': 'Days 29 and 30 (n = 5, 5)', 'categories': [{'measurements': [{'value': '1.16', 'spread': '0.11', 'groupId': 'OG000'}, {'value': '1.16', 'spread': '0.13', 'groupId': 'OG001'}]}]}, {'title': 'Days 57 and 58 (n = 5, 5)', 'categories': [{'measurements': [{'value': '1.12', 'spread': '0.11', 'groupId': 'OG000'}, {'value': '1.16', 'spread': '0.13', 'groupId': 'OG001'}]}]}, {'title': 'Days 88 and 90 (n = 5, 5)', 'categories': [{'measurements': [{'value': '1.08', 'spread': '0.18', 'groupId': 'OG000'}, {'value': '1.12', 'spread': '0.08', 'groupId': 'OG001'}]}]}, {'title': '1 wk postdose (n = 5, 5)', 'categories': [{'measurements': [{'value': '1.22', 'spread': '0.13', 'groupId': 'OG000'}, {'value': '1.15', 'spread': '0.10', 'groupId': 'OG001'}]}]}, {'title': '2 wk postdose (n = 5, 5)', 'categories': [{'measurements': [{'value': '1.06', 'spread': '0.11', 'groupId': 'OG000'}, {'value': '1.14', 'spread': '0.05', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Study volunteers were assessed before, during and after cobalt supplementation (2 wk post)', 'description': 'Blood chemistries assessed during the study included a lipid panel, comprehensive metabolic panel, creatine kinase-myocardial band, thyroid stimulating hormone, free thyroxine, and complete blood count with differential, total iron, and ferritin. Blood chemistries were assessed at one or two week pre-dose, pre-dose/ Day 1 before taking the supplement, Day 29/30, Day 57/58, Day 88/90 and one and two weeks post-dose.', 'unitOfMeasure': 'ng/dL', 'dispersionType': 'Standard Deviation', 'populationDescription': 'Participants that completed three months of cobalt supplementation.Individual baseline values for the 1-wk predose draw and the day 1 (predose) draw were averaged together to give one baseline value.'}, {'type': 'SECONDARY', 'title': 'Total Iron Levels After 1, 2 and 3 Months of Dosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Female Total Iron', 'description': 'Total iron levels before, during and after dosing'}, {'id': 'OG001', 'title': 'Male Total Iron', 'description': 'Total iron levels before, during, and after dosing'}], 'classes': [{'title': 'Baseline (n = 5, 5)', 'categories': [{'measurements': [{'value': '88.4', 'spread': '12.6', 'groupId': 'OG000'}, {'value': '122', 'spread': '26.4', 'groupId': 'OG001'}]}]}, {'title': 'Days 29 and 30 (n = 5, 5)', 'categories': [{'measurements': [{'value': '77.4', 'spread': '21.5', 'groupId': 'OG000'}, {'value': '119', 'spread': '39.5', 'groupId': 'OG001'}]}]}, {'title': 'Days 57 and 58 (n = 5, 5)', 'categories': [{'measurements': [{'value': '84.6', 'spread': '19.4', 'groupId': 'OG000'}, {'value': '105', 'spread': '47.1', 'groupId': 'OG001'}]}]}, {'title': 'Days 88 and 90 (n = 5, 5)', 'categories': [{'measurements': [{'value': '79.2', 'spread': '21', 'groupId': 'OG000'}, {'value': '82.6', 'spread': '32.6', 'groupId': 'OG001'}]}]}, {'title': '1 wk postdose (n = 5, 5)', 'categories': [{'measurements': [{'value': '77.6', 'spread': '51.4', 'groupId': 'OG000'}, {'value': '115', 'spread': '37.1', 'groupId': 'OG001'}]}]}, {'title': '2 wk postdose (n = 5, 5)', 'categories': [{'measurements': [{'value': '64', 'spread': '11.6', 'groupId': 'OG000'}, {'value': '111', 'spread': '42.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Study volunteers were assessed before, during and after cobalt supplementation (2 wk post)', 'description': 'Blood chemistries assessed during the study included a lipid panel, comprehensive metabolic panel, creatine kinase-myocardial band, thyroid stimulating hormone, free thyroxine, and complete blood count with differential, total iron, and ferritin. Blood chemistries were assessed at one or two week pre-dose, pre-dose/ Day 1 before taking the supplement, Day 29/30, Day 57/58, Day 88/90 and one and two weeks post-dose.', 'unitOfMeasure': 'µg/dL', 'dispersionType': 'Standard Deviation', 'populationDescription': 'Participants that completed three months of cobalt supplementation. Individual baseline values for the 1-wk predose draw and the day 1 (predose) draw were averaged together to give one baseline value.'}, {'type': 'SECONDARY', 'title': 'Ferritin Levels After 1, 2 and 3 Months of Dosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Female Ferritin', 'description': 'Ferritin levels before, during and after dosing'}, {'id': 'OG001', 'title': 'Male Ferritin', 'description': 'Ferritin levels before, during, and after dosing'}], 'classes': [{'title': 'Baseline (n = 5, 5)', 'categories': [{'measurements': [{'value': '51.3', 'spread': '40.4', 'groupId': 'OG000'}, {'value': '136', 'spread': '77.3', 'groupId': 'OG001'}]}]}, {'title': 'Days 29 and 30 (n = 5, 5)', 'categories': [{'measurements': [{'value': '32.0', 'spread': '24.2', 'groupId': 'OG000'}, {'value': '95.2', 'spread': '57.5', 'groupId': 'OG001'}]}]}, {'title': 'Days 57 and 58 (n = 5, 5)', 'categories': [{'measurements': [{'value': '27.4', 'spread': '23.2', 'groupId': 'OG000'}, {'value': '86.6', 'spread': '59.6', 'groupId': 'OG001'}]}]}, {'title': 'Days 88 and 90 (n = 5, 5)', 'categories': [{'measurements': [{'value': '21.6', 'spread': '14.7', 'groupId': 'OG000'}, {'value': '85.2', 'spread': '53.1', 'groupId': 'OG001'}]}]}, {'title': '1 wk postdose (n = 5, 5)', 'categories': [{'measurements': [{'value': '34.6', 'spread': '43.4', 'groupId': 'OG000'}, {'value': '74.6', 'spread': '50.3', 'groupId': 'OG001'}]}]}, {'title': '2 wk postdose (n = 5, 5)', 'categories': [{'measurements': [{'value': '24.8', 'spread': '18.7', 'groupId': 'OG000'}, {'value': '90.4', 'spread': '66.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Study volunteers were assessed before, during and after cobalt supplementation (2 wk post)', 'description': 'Blood chemistries assessed during the study included a lipid panel, comprehensive metabolic panel, creatine kinase-myocardial band, thyroid stimulating hormone, free thyroxine, and complete blood count with differential, total iron, and ferritin. Blood chemistries were assessed at one or two week pre-dose, pre-dose/ Day 1 before taking the supplement, Day 29/30, Day 57/58, Day 88/90 and one and two weeks post-dose.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'populationDescription': 'Participants that completed three months of cobalt supplementation. Individual female baseline values for the 1-wk predose draw and the day 1 (predose) draw were averaged together. For males, the average baseline is the 1-wk predose data only because there was a significant difference between the 1-wk predose draw and the day 1 (predose) draw.'}, {'type': 'SECONDARY', 'title': 'Creatine Creatine Kinase-Myocardial Band (CK-MB) Levels After 1, 2 and 3 Months of Dosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Female CK-MB', 'description': 'CK-MB levels before, during and after dosing'}, {'id': 'OG001', 'title': 'Male CK-MB', 'description': 'CK-MB levels before, during, and after dosing'}], 'classes': [{'title': 'Baseline (n = 5, 5)', 'categories': [{'measurements': [{'value': '0.61', 'spread': '0.37', 'groupId': 'OG000'}, {'value': '1.58', 'spread': '0.68', 'groupId': 'OG001'}]}]}, {'title': 'Days 29 and 30 (n = 5, 5)', 'categories': [{'measurements': [{'value': '0.80', 'spread': '0.45', 'groupId': 'OG000'}, {'value': '0.97', 'spread': '0.95', 'groupId': 'OG001'}]}]}, {'title': 'Days 57 and 58 (n = 5, 5)', 'categories': [{'measurements': [{'value': '0.59', 'spread': '0.35', 'groupId': 'OG000'}, {'value': '0.92', 'spread': '0.85', 'groupId': 'OG001'}]}]}, {'title': 'Days 88 and 90 (n = 5, 5)', 'categories': [{'measurements': [{'value': '1.03', 'spread': '0.56', 'groupId': 'OG000'}, {'value': '1.23', 'spread': '0.82', 'groupId': 'OG001'}]}]}, {'title': '1 wk postdose (n = 5, 5)', 'categories': [{'measurements': [{'value': '0.81', 'spread': '0.36', 'groupId': 'OG000'}, {'value': '1.25', 'spread': '1.08', 'groupId': 'OG001'}]}]}, {'title': '2 wk postdose (n = 5, 5)', 'categories': [{'measurements': [{'value': '1.09', 'spread': '0.48', 'groupId': 'OG000'}, {'value': '1.42', 'spread': '1.53', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Study volunteers were assessed before, during and after cobalt supplementation (2 wk post)', 'description': 'Blood chemistries assessed during the study included a lipid panel, comprehensive metabolic panel, creatine kinase-myocardial band, thyroid stimulating hormone, free thyroxine, and complete blood count with differential, total iron, and ferritin. Blood chemistries were assessed at one or two week pre-dose, pre-dose/ Day 1 before taking the supplement, Day 29/30, Day 57/58, Day 88/90 and one and two weeks post-dose.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'populationDescription': 'Participants that completed three months of cobalt supplementation. Individual female baseline values for the 1-wk predose draw and the day 1 (predose) draw were averaged together. For males, the average baseline is the 1-wk predose data only because there was a significant difference between the 1-wk predose draw and the day 1 (predose) draw.'}, {'type': 'SECONDARY', 'title': 'Creatinine Levels After 1, 2 and 3 Months of Dosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Female Creatine', 'description': 'Creatine levels before, during and after dosing'}, {'id': 'OG001', 'title': 'Male Creatine', 'description': 'Creatine levels before, during, and after dosing'}], 'classes': [{'title': 'Baseline (n = 5, 5)', 'categories': [{'measurements': [{'value': '0.79', 'spread': '0.09', 'groupId': 'OG000'}, {'value': '1.05', 'spread': '0.09', 'groupId': 'OG001'}]}]}, {'title': 'Days 29 and 30 (n = 5, 5)', 'categories': [{'measurements': [{'value': '0.78', 'spread': '0.07', 'groupId': 'OG000'}, {'value': '1.01', 'spread': '0.16', 'groupId': 'OG001'}]}]}, {'title': 'Days 57 and 58 (n = 5, 5)', 'categories': [{'measurements': [{'value': '0.77', 'spread': '0.08', 'groupId': 'OG000'}, {'value': '1.04', 'spread': '0.11', 'groupId': 'OG001'}]}]}, {'title': 'Days 88 and 90 (n = 5, 5)', 'categories': [{'measurements': [{'value': '0.80', 'spread': '0.06', 'groupId': 'OG000'}, {'value': '0.99', 'spread': '0.10', 'groupId': 'OG001'}]}]}, {'title': '1 wk postdose (n = 5, 5)', 'categories': [{'measurements': [{'value': '0.84', 'spread': '0.09', 'groupId': 'OG000'}, {'value': '1.02', 'spread': '0.12', 'groupId': 'OG001'}]}]}, {'title': '2 wk postdose (n = 5, 5)', 'categories': [{'measurements': [{'value': '0.82', 'spread': '0.13', 'groupId': 'OG000'}, {'value': '1.05', 'spread': '0.10', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Study volunteers were assessed before, during and after cobalt supplementation (2 wk post)', 'description': 'Blood chemistries assessed during the study included a lipid panel, comprehensive metabolic panel, creatine kinase-myocardial band, thyroid stimulating hormone, free thyroxine, and complete blood count with differential, total iron, and ferritin. Blood chemistries were assessed at one or two week pre-dose, pre-dose/ Day 1 before taking the supplement, Day 29/30, Day 57/58, Day 88/90 and one and two weeks post-dose.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'populationDescription': 'Participants that completed three months of cobalt supplementation. Individual baseline values for the 1-wk predose draw and the day 1 (predose) draw were averaged together to give one baseline value.'}, {'type': 'SECONDARY', 'title': 'Alanine Aminotransferase (ALT) Levels After 1, 2 and 3 Months of Dosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Female ALT', 'description': 'ALT levels before, during and after dosing'}, {'id': 'OG001', 'title': 'Male ALT', 'description': 'ALT levels before, during, and after dosing'}], 'classes': [{'title': 'Baseline (n = 5, 5)', 'categories': [{'measurements': [{'value': '14.8', 'spread': '4.19', 'groupId': 'OG000'}, {'value': '30.6', 'spread': '19.3', 'groupId': 'OG001'}]}]}, {'title': 'Days 29 and 30 (n = 5, 5)', 'categories': [{'measurements': [{'value': '13.6', 'spread': '4.39', 'groupId': 'OG000'}, {'value': '26.2', 'spread': '13.5', 'groupId': 'OG001'}]}]}, {'title': 'Days 57 and 58 (n = 5, 5)', 'categories': [{'measurements': [{'value': '14.8', 'spread': '6.61', 'groupId': 'OG000'}, {'value': '32.0', 'spread': '19.3', 'groupId': 'OG001'}]}]}, {'title': 'Days 88 and 90 (n = 5, 5)', 'categories': [{'measurements': [{'value': '11.2', 'spread': '3.11', 'groupId': 'OG000'}, {'value': '29.4', 'spread': '17.1', 'groupId': 'OG001'}]}]}, {'title': '1 wk postdose (n = 5, 5)', 'categories': [{'measurements': [{'value': '12.6', 'spread': '3.85', 'groupId': 'OG000'}, {'value': '29.8', 'spread': '15.6', 'groupId': 'OG001'}]}]}, {'title': '2 wk postdose (n = 5, 5)', 'categories': [{'measurements': [{'value': '15.8', 'spread': '4.87', 'groupId': 'OG000'}, {'value': '29.8', 'spread': '14.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Study volunteers were assessed before, during and after cobalt supplementation (2 wk post)', 'description': 'Blood chemistries assessed during the study included a lipid panel, comprehensive metabolic panel, creatine kinase-myocardial band, thyroid stimulating hormone, free thyroxine, and complete blood count with differential, total iron, and ferritin. Blood chemistries were assessed at one or two week pre-dose, pre-dose/ Day 1 before taking the supplement, Day 29/30, Day 57/58, Day 88/90 and one and two weeks post-dose.', 'unitOfMeasure': 'U/L', 'dispersionType': 'Standard Deviation', 'populationDescription': 'Participants that completed three months of cobalt supplementation. Individual baseline values for the 1-wk predose draw and the day 1 (predose) draw were averaged together to give one baseline value.'}, {'type': 'SECONDARY', 'title': 'Aspartate Aminotransferase (AST) Levels After 1, 2 and 3 Months of Dosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Female AST', 'description': 'AST levels before, during and after dosing'}, {'id': 'OG001', 'title': 'Male AST', 'description': 'AST levels before, during, and after dosing'}], 'classes': [{'title': 'Baseline (n = 5, 5)', 'categories': [{'measurements': [{'value': '18.8', 'spread': '4.63', 'groupId': 'OG000'}, {'value': '22.9', 'spread': '4.26', 'groupId': 'OG001'}]}]}, {'title': 'Days 29 and 30 (n = 5, 5)', 'categories': [{'measurements': [{'value': '17.6', 'spread': '3.51', 'groupId': 'OG000'}, {'value': '21.0', 'spread': '4.06', 'groupId': 'OG001'}]}]}, {'title': 'Days 57 and 58 (n = 5, 5)', 'categories': [{'measurements': [{'value': '20.2', 'spread': '8.87', 'groupId': 'OG000'}, {'value': '22.4', 'spread': '7.02', 'groupId': 'OG001'}]}]}, {'title': 'Days 88 and 90 (n = 5, 5)', 'categories': [{'measurements': [{'value': '15.8', 'spread': '4.66', 'groupId': 'OG000'}, {'value': '23.4', 'spread': '6.5', 'groupId': 'OG001'}]}]}, {'title': '1 wk postdose (n = 5, 5)', 'categories': [{'measurements': [{'value': '16.8', 'spread': '5.36', 'groupId': 'OG000'}, {'value': '23.6', 'spread': '4.72', 'groupId': 'OG001'}]}]}, {'title': '2 wk postdose (n = 5, 5)', 'categories': [{'measurements': [{'value': '20.6', 'spread': '6.66', 'groupId': 'OG000'}, {'value': '25.8', 'spread': '9.60', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Study volunteers were assessed before, during and after cobalt supplementation (2 wk post)', 'description': 'Blood chemistries assessed during the study included a lipid panel, comprehensive metabolic panel, creatine kinase-myocardial band, thyroid stimulating hormone, free thyroxine, and complete blood count with differential, total iron, and ferritin. Blood chemistries were assessed at one or two week pre-dose, pre-dose/ Day 1 before taking the supplement, Day 29/30, Day 57/58, Day 88/90 and one and two weeks post-dose.', 'unitOfMeasure': 'U/L', 'dispersionType': 'Standard Deviation', 'populationDescription': 'Participants that completed three months of cobalt supplementation. Individual baseline values for the 1-wk predose draw and the day 1 (predose) draw were averaged together to give one baseline value.'}, {'type': 'SECONDARY', 'title': 'HDL Cholesterol Levels After 3 Months of Cobalt Supplementation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Female HDL Cholesterol', 'description': 'HDL cholesterol levels before and after cobalt supplementation'}, {'id': 'OG001', 'title': 'Male HDL Cholesterol', 'description': 'HDL cholesterol levels before and after cobalt supplementation'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '85.2', 'spread': '19.0', 'groupId': 'OG000'}, {'value': '50.2', 'spread': '14.1', 'groupId': 'OG001'}]}]}, {'title': 'Days 88 and 90', 'categories': [{'measurements': [{'value': '78.4', 'spread': '23.1', 'groupId': 'OG000'}, {'value': '50.6', 'spread': '11.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Study volunteers were assessed before and at the end of cobalt supplementation', 'description': 'Blood chemistries assessed during the study included a lipid panel, comprehensive metabolic panel, creatine kinase-myocardial band, thyroid stimulating hormone, free thyroxine, and complete blood count with differential, total iron, and ferritin. HDL cholesterol levels were assessed before cobalt dietary supplementation and after three months of supplementation.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'populationDescription': 'Participants that completed three months of cobalt supplementation'}, {'type': 'SECONDARY', 'title': 'Total Cholesterol Levels After 3 Months of Cobalt Supplementation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Female Total Cholesterol', 'description': 'Total cholesterol levels before and after cobalt supplementation'}, {'id': 'OG001', 'title': 'Male Total Cholesterol', 'description': 'Total cholesterol levels before and after cobalt supplementation'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '209', 'spread': '31.7', 'groupId': 'OG000'}, {'value': '179', 'spread': '26.6', 'groupId': 'OG001'}]}]}, {'title': 'Days 88 and 90', 'categories': [{'measurements': [{'value': '220', 'spread': '54.6', 'groupId': 'OG000'}, {'value': '188', 'spread': '46.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Study volunteers were assessed before and at the end of cobalt supplementation', 'description': 'Blood chemistries assessed during the study included a lipid panel, comprehensive metabolic panel, creatine kinase-myocardial band, thyroid stimulating hormone, free thyroxine, and complete blood count with differential, total iron, and ferritin. Total cholesterol levels were assessed before cobalt dietary supplementation and after three months of supplementation.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'populationDescription': 'Participants that completed three months of cobalt supplementation'}, {'type': 'SECONDARY', 'title': 'Triglyceride Levels After 3 Months of Cobalt Supplementation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Female Triglycerides', 'description': 'Triglyceride levels before and after cobalt supplementation'}, {'id': 'OG001', 'title': 'Male Triglycerides', 'description': 'Triglyceride levels before and after cobalt supplementation'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '105', 'spread': '41.3', 'groupId': 'OG000'}, {'value': '113', 'spread': '51.1', 'groupId': 'OG001'}]}]}, {'title': 'Days 88 and 90', 'categories': [{'measurements': [{'value': '95.6', 'spread': '29.6', 'groupId': 'OG000'}, {'value': '122', 'spread': '71.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Study volunteers were assessed before and at the end of cobalt supplementation', 'description': 'Blood chemistries assessed during the study included a lipid panel, comprehensive metabolic panel, creatine kinase-myocardial band, thyroid stimulating hormone, free thyroxine, and complete blood count with differential, total iron, and ferritin. Triglyceride levels were assessed before cobalt dietary supplementation and after three months of supplementation.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'populationDescription': 'Participants that completed three months of cobalt supplementation'}, {'type': 'SECONDARY', 'title': 'Glucose Levels After 1, 2 and 3 Months of Dosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Female Glucose', 'description': 'Glucose levels before, during and after dosing'}, {'id': 'OG001', 'title': 'Male Glucose', 'description': 'Glucose levels before, during, and after dosing'}], 'classes': [{'title': 'Baseline (n = 5, 5)', 'categories': [{'measurements': [{'value': '88.2', 'spread': '7.53', 'groupId': 'OG000'}, {'value': '89.9', 'spread': '13', 'groupId': 'OG001'}]}]}, {'title': 'Days 29 and 30 (n = 5, 5)', 'categories': [{'measurements': [{'value': '82.2', 'spread': '10.1', 'groupId': 'OG000'}, {'value': '83.4', 'spread': '9.76', 'groupId': 'OG001'}]}]}, {'title': 'Days 57 and 58 (n = 5, 5)', 'categories': [{'measurements': [{'value': '86.4', 'spread': '9.4', 'groupId': 'OG000'}, {'value': '81.2', 'spread': '26.1', 'groupId': 'OG001'}]}]}, {'title': 'Days 88 and 90 (n = 5, 5)', 'categories': [{'measurements': [{'value': '83.2', 'spread': '9.91', 'groupId': 'OG000'}, {'value': '87.4', 'spread': '13.8', 'groupId': 'OG001'}]}]}, {'title': '1 wk postdose (n = 5, 5)', 'categories': [{'measurements': [{'value': '79.6', 'spread': '14.5', 'groupId': 'OG000'}, {'value': '90.6', 'spread': '2.97', 'groupId': 'OG001'}]}]}, {'title': '2 wk postdose (n = 5, 5)', 'categories': [{'measurements': [{'value': '88.4', 'spread': '15.1', 'groupId': 'OG000'}, {'value': '79.4', 'spread': '9.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Study volunteers were assessed before, during and after cobalt supplementation (2 wk post)', 'description': 'Blood chemistries assessed during the study included a lipid panel, comprehensive metabolic panel, creatine kinase-myocardial band, thyroid stimulating hormone, free thyroxine, and complete blood count with differential, total iron, and ferritin. Blood chemistries were assessed at one or two week pre-dose, pre-dose/ Day 1 before taking the supplement, Day 29/30, Day 57/58, Day 88/90 and one and two weeks post-dose.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'populationDescription': 'Participants that completed three months of cobalt supplementation. Individual male baseline values for the 1-wk predose draw and the day 1 (predose) draw were averaged together. For females, the average baseline is the 1-wk predose data only because there was a significant difference between the 1-wk predose draw and the day 1 (predose) draw.'}, {'type': 'SECONDARY', 'title': 'Cobalt Urine Concentrations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Female Cobalt Urine Concentrations', 'description': 'Cobalt urine concentrations during daily oral intake of 1 mg Co.'}, {'id': 'OG001', 'title': 'Male Cobalt Urine Concentrations', 'description': 'Cobalt urine concentrations during daily oral intake of 1 mg Co.'}], 'classes': [{'title': 'Day 14/16', 'categories': [{'measurements': [{'value': '186', 'spread': '170', 'groupId': 'OG000'}, {'value': '119', 'spread': '114', 'groupId': 'OG001'}]}]}, {'title': 'Day 43/44', 'categories': [{'measurements': [{'value': '226', 'spread': '228', 'groupId': 'OG000'}, {'value': '46', 'spread': '35', 'groupId': 'OG001'}]}]}, {'title': 'Day 88/90', 'categories': [{'measurements': [{'value': '193', 'spread': '179', 'groupId': 'OG000'}, {'value': '70', 'spread': '29', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'During cobalt supplementation', 'description': 'A 24 hr urine collection for cobalt analysis was performed at Day 14/16, Day 43/44 and Day 88/90.', 'unitOfMeasure': 'µg/L', 'dispersionType': 'Standard Deviation', 'populationDescription': 'Participants that completed three months of cobalt supplementation'}, {'type': 'SECONDARY', 'title': 'Cobalt Urine Concentrations After Cessation of Cobalt Supplementation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Female Cobalt Urine Concentrations', 'description': 'Cobalt urine concentrations after cessation of cobalt supplementation'}, {'id': 'OG001', 'title': 'Male Cobalt Urine Concentrations', 'description': 'Cobalt urine concentrations after cessation of cobalt supplementation'}], 'classes': [{'title': '1 wk postdose (n = 5, 3)', 'categories': [{'measurements': [{'value': '38', 'spread': '29', 'groupId': 'OG000'}, {'value': '14', 'spread': '6', 'groupId': 'OG001'}]}]}, {'title': '2 wk postdose (n = 4, 3)', 'categories': [{'measurements': [{'value': '19', 'spread': '18', 'groupId': 'OG000'}, {'value': '7', 'spread': '2', 'groupId': 'OG001'}]}]}, {'title': '6 wk postdose (n = 2, 1)', 'categories': [{'measurements': [{'value': '6', 'spread': '5', 'groupId': 'OG000'}, {'value': '2', 'spread': '0', 'groupId': 'OG001'}]}]}, {'title': '10 wk postdose (n = 2, 1)', 'categories': [{'measurements': [{'value': '6', 'spread': '7', 'groupId': 'OG000'}, {'value': '1', 'spread': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'After cobalt supplementation', 'description': 'A 24 hr urine collection for cobalt analysis was performed on three volunteers (two females and one male) at one, two, six and ten weeks post-dosing. The one male volunteer provided three consecutive 24-hr urine samples at the one and two week post-dosing time points; data for individual urine collections were averaged together to give an average one and two week post-dosing data concentration.', 'unitOfMeasure': 'µg/L', 'dispersionType': 'Standard Deviation', 'populationDescription': 'Participants that completed three months of cobalt supplementation and volunteered to do additional urine collections after stopping cobalt supplementation. "n" represents the number of urine samples analyzd at each time point.'}, {'type': 'PRIMARY', 'title': 'Cobalt Serum Concentrations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Female Cobalt Serum Concentrations', 'description': 'Volunteers (males and females) were instructed to take the cobalt dietary supplement in the morning according to the manufacturer\'s label, which suggested a serving of 1 mg cobalt (\\~2 mL) daily "in water or juice as maintenance." Dietary supplementation lasted for approximately three months.'}, {'id': 'OG001', 'title': 'Male Cobalt Serum Concentrations', 'description': 'Volunteers (males and females) were instructed to take the cobalt dietary supplement in the morning according to the manufacturer\'s label, which suggested a serving of 1 mg cobalt (\\~2 mL) daily "in water or juice as maintenance." Dietary supplementation lasted for approximately three months.'}], 'classes': [{'title': 'Day 4/5', 'categories': [{'measurements': [{'value': '23.3', 'spread': '12.4', 'groupId': 'OG000'}, {'value': '11.0', 'spread': '5.7', 'groupId': 'OG001'}]}]}, {'title': 'Day 8/9', 'categories': [{'measurements': [{'value': '42.3', 'spread': '33.4', 'groupId': 'OG000'}, {'value': '11.8', 'spread': '9.7', 'groupId': 'OG001'}]}]}, {'title': 'Day 14/16', 'categories': [{'measurements': [{'value': '42.5', 'spread': '30.9', 'groupId': 'OG000'}, {'value': '20.4', 'spread': '11.5', 'groupId': 'OG001'}]}]}, {'title': 'Day 22/24', 'categories': [{'measurements': [{'value': '36.8', 'spread': '24.2', 'groupId': 'OG000'}, {'value': '34.7', 'spread': '23.1', 'groupId': 'OG001'}]}]}, {'title': 'Day 29/30', 'categories': [{'measurements': [{'value': '53.9', 'spread': '35.8', 'groupId': 'OG000'}, {'value': '23.9', 'spread': '8.7', 'groupId': 'OG001'}]}]}, {'title': 'Day 43/44', 'categories': [{'measurements': [{'value': '48.2', 'spread': '34.5', 'groupId': 'OG000'}, {'value': '24.3', 'spread': '16.5', 'groupId': 'OG001'}]}]}, {'title': 'Day 57/58', 'categories': [{'measurements': [{'value': '34.9', 'spread': '20.3', 'groupId': 'OG000'}, {'value': '24.1', 'spread': '15.7', 'groupId': 'OG001'}]}]}, {'title': 'Day 71/72', 'categories': [{'measurements': [{'value': '46.1', 'spread': '40.8', 'groupId': 'OG000'}, {'value': '28.2', 'spread': '18.0', 'groupId': 'OG001'}]}]}, {'title': 'Day 88/90', 'categories': [{'measurements': [{'value': '71.2', 'spread': '60.0', 'groupId': 'OG000'}, {'value': '25.2', 'spread': '13.2', 'groupId': 'OG001'}]}]}, {'title': '1 wk post', 'categories': [{'measurements': [{'value': '21.9', 'spread': '20.6', 'groupId': 'OG000'}, {'value': '8.4', 'spread': '3.1', 'groupId': 'OG001'}]}]}, {'title': '2 wk post', 'categories': [{'measurements': [{'value': '12.5', 'spread': '11.6', 'groupId': 'OG000'}, {'value': '4.6', 'spread': '1.6', 'groupId': 'OG001'}]}]}, {'title': '6 wk post', 'categories': [{'measurements': [{'value': '3.8', 'spread': '3.3', 'groupId': 'OG000'}, {'value': '1.4', 'spread': '0.8', 'groupId': 'OG001'}]}]}, {'title': '10 wk post', 'categories': [{'measurements': [{'value': '1.9', 'spread': '1.5', 'groupId': 'OG000'}, {'value': '0.9', 'spread': '0.4', 'groupId': 'OG001'}]}]}, {'title': '4 month post', 'categories': [{'measurements': [{'value': '0.96', 'spread': '0.6', 'groupId': 'OG000'}, {'value': '0.5', 'spread': '0.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Before, during and after cobalt supplementation', 'description': 'The cobalt concentration in whole blood and serum was determined one to two weeks pre-dosing and on the day of the first day of dosing before taking the supplement. Samples were also analyzed during the dosing period as follows: Day 4/5, Day 8/9, Day 14/16, Day 22/23, Day 29/30, Day 43/44, Day 57/58, Day 71/72, and Day 88/90. Cobalt concentration in whole blood and serum was also determined at one, two, six, ten and 16 weeks post-dosing.', 'unitOfMeasure': 'µg Co/L', 'dispersionType': 'Standard Deviation', 'populationDescription': 'Participants that completed three months of cobalt supplementation'}, {'type': 'SECONDARY', 'title': 'Changes in Cardiac Function (LVEF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Prestudy', 'description': 'Comparison of left and right ventricular function in volunteers before and after cobalt supplementation'}, {'id': 'OG001', 'title': 'Study Midpoint', 'description': 'Comparison of left and right ventricular function in volunteers before and after cobalt supplementation'}, {'id': 'OG002', 'title': 'Study Completion', 'description': 'Comparison of left and right ventricular function in volunteers before and after cobalt supplementation'}], 'classes': [{'categories': [{'measurements': [{'value': '65.9', 'spread': '4.43', 'groupId': 'OG000'}, {'value': '66.8', 'spread': '4.21', 'groupId': 'OG001'}, {'value': '65.0', 'spread': '2.54', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, at the study midpoint, and at the study completion', 'description': 'Two-dimensional and Doppler echocardiographic examinations were used to assess cardiac anatomy, structure, and function during the study with volunteers serving as their own baseline controls for changes during the study (i.e., week 0, \\~day 45, \\~day 90).', 'unitOfMeasure': 'LVEF (2D est) (%)', 'dispersionType': 'Standard Deviation', 'populationDescription': 'Participants that completed three months of cobalt supplementation'}, {'type': 'SECONDARY', 'title': 'Changes in Cardiac Function (LA Volume Index)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Prestudy', 'description': 'Comparison of left and right ventricular function in volunteers before and after cobalt supplementation'}, {'id': 'OG001', 'title': 'Study Midpoint', 'description': 'Comparison of left and right ventricular function in volunteers before and after cobalt supplementation'}, {'id': 'OG002', 'title': 'Study Completion', 'description': 'Comparison of left and right ventricular function in volunteers before and after cobalt supplementation'}], 'classes': [{'categories': [{'measurements': [{'value': '23.3', 'spread': '4.27', 'groupId': 'OG000'}, {'value': '24.2', 'spread': '5.33', 'groupId': 'OG001'}, {'value': '24.0', 'spread': '6.08', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, at the study midpoint, and at the study completion', 'description': 'Two-dimensional and Doppler echocardiographic examinations were used to assess cardiac anatomy, structure, and function during the study with volunteers serving as their own baseline controls for changes during the study (i.e., week 0, \\~day 45, \\~day 90).', 'unitOfMeasure': 'LA volume index (mL/m^2)', 'dispersionType': 'Standard Deviation', 'populationDescription': 'Participants that completed three months of cobalt supplementation'}, {'type': 'SECONDARY', 'title': 'Changes in Visual Function (Average RNFL Thickness)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Prestudy - Right', 'description': 'Values of the right eye for select RNFL variables'}, {'id': 'OG001', 'title': 'Prestudy - Left', 'description': 'Values of the left eye for select RNFL variables'}, {'id': 'OG002', 'title': 'Study Midpoint - Right', 'description': 'Values of the right eye for select RNFL variables'}, {'id': 'OG003', 'title': 'Study Midpoint - Left', 'description': 'Values of the left eye for select RNFL variables'}, {'id': 'OG004', 'title': 'Study Completion - Right', 'description': 'Values of the right eye for select RNFL variables'}, {'id': 'OG005', 'title': 'Study Completion - Left', 'description': 'Values of the left eye for select RNFL variables'}], 'classes': [{'categories': [{'measurements': [{'value': '97.10', 'spread': '7.89', 'groupId': 'OG000'}, {'value': '97.00', 'spread': '8.67', 'groupId': 'OG001'}, {'value': '97.00', 'spread': '7.89', 'groupId': 'OG002'}, {'value': '96.30', 'spread': '8.64', 'groupId': 'OG003'}, {'value': '96.50', 'spread': '7.81', 'groupId': 'OG004'}, {'value': '96.50', 'spread': '9.01', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, at the study midpoint, and at the study completion', 'description': 'Ophthalmology studies included an assessment of visual acuity, slit lamp evaluations, and visual field testing. Retinal nerve fiber layer (RNFL) thickness and optic nerve head (ONH) were assessed using optical coherence tomography (OCT). Volunteers served as their own baseline controls for changes during the study (i.e., week 0, \\~day 45, \\~day 90).', 'unitOfMeasure': 'Average RNFL thickness (µm)', 'dispersionType': 'Standard Deviation', 'populationDescription': 'Participants that completed three months of cobalt supplementation'}, {'type': 'SECONDARY', 'title': 'Changes in Visual Function (Average C:D Ratio)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Prestudy - Right', 'description': 'Values of the right eye for select OHN variables'}, {'id': 'OG001', 'title': 'Prestudy - Left', 'description': 'Values of the left eye for select OHN variables'}, {'id': 'OG002', 'title': 'Study Midpoint - Right', 'description': 'Values of the right eye for select OHN variables'}, {'id': 'OG003', 'title': 'Study Midpoint - Left', 'description': 'Values of the left eye for select OHN variables'}, {'id': 'OG004', 'title': 'Study Completion - Right', 'description': 'Values of the right eye for select OHN variables'}, {'id': 'OG005', 'title': 'Study Completion - Left', 'description': 'Values of the left eye for select OHN variables'}], 'classes': [{'title': 'Average C:D ratio', 'categories': [{'measurements': [{'value': '0.43', 'spread': '0.12', 'groupId': 'OG000'}, {'value': '0.44', 'spread': '0.11', 'groupId': 'OG001'}, {'value': '0.41', 'spread': '0.13', 'groupId': 'OG002'}, {'value': '0.42', 'spread': '0.12', 'groupId': 'OG003'}, {'value': '0.40', 'spread': '0.12', 'groupId': 'OG004'}, {'value': '0.40', 'spread': '0.11', 'groupId': 'OG005'}]}]}, {'title': 'Vertical C:D ratio', 'categories': [{'measurements': [{'value': '0.41', 'spread': '0.13', 'groupId': 'OG000'}, {'value': '0.40', 'spread': '0.10', 'groupId': 'OG001'}, {'value': '0.40', 'spread': '0.12', 'groupId': 'OG002'}, {'value': '0.39', 'spread': '0.11', 'groupId': 'OG003'}, {'value': '0.38', 'spread': '0.13', 'groupId': 'OG004'}, {'value': '0.36', 'spread': '0.10', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, at the study midpoint, and at the study completion', 'description': 'Ophthalmology studies included an assessment of visual acuity, slit lamp evaluations, and visual field testing. Retinal nerve fiber layer (RNFL) thickness and optic nerve head (ONH) were assessed using optical coherence tomography (OCT). Volunteers served as their own baseline controls for changes during the study (i.e., week 0, \\~day 45, \\~day 90).', 'unitOfMeasure': 'ratio', 'dispersionType': 'Standard Deviation', 'populationDescription': 'Participants that completed three months of cobalt supplementation'}, {'type': 'SECONDARY', 'title': 'Changes in Visual Function (Cup Volume)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Prestudy - Right', 'description': 'Values of the right eye for select OHN variables'}, {'id': 'OG001', 'title': 'Prestudy - Left', 'description': 'Values of the left eye for select OHN variables'}, {'id': 'OG002', 'title': 'Study Midpoint - Right', 'description': 'Values of the right eye for select OHN variables'}, {'id': 'OG003', 'title': 'Study Midpoint - Left', 'description': 'Values of the left eye for select OHN variables'}, {'id': 'OG004', 'title': 'Study Completion - Right', 'description': 'Values of the right eye for select OHN variables'}, {'id': 'OG005', 'title': 'Study Completion - Left', 'description': 'Values of the left eye for select OHN variables'}], 'classes': [{'categories': [{'measurements': [{'value': '0.09', 'spread': '0.06', 'groupId': 'OG000'}, {'value': '0.08', 'spread': '0.04', 'groupId': 'OG001'}, {'value': '0.08', 'spread': '0.05', 'groupId': 'OG002'}, {'value': '0.07', 'spread': '0.04', 'groupId': 'OG003'}, {'value': '0.08', 'spread': '0.05', 'groupId': 'OG004'}, {'value': '0.07', 'spread': '0.04', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, at the study midpoint, and at the study completion', 'description': 'Ophthalmology studies included an assessment of visual acuity, slit lamp evaluations, and visual field testing. Retinal nerve fiber layer (RNFL) thickness and optic nerve head (ONH) were assessed using optical coherence tomography (OCT). Volunteers served as their own baseline controls for changes during the study (i.e., week 0, \\~day 45, \\~day 90).', 'unitOfMeasure': 'mm^3', 'dispersionType': 'Standard Deviation'}, {'type': 'SECONDARY', 'title': 'Changes in Visual Function (VFI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Prestudy - Right', 'description': 'Values of the right eye for select VFI variables'}, {'id': 'OG001', 'title': 'Prestudy - Left', 'description': 'Values of the left eye for select VFI variables'}, {'id': 'OG002', 'title': 'Study Midpoint - Right', 'description': 'Values of the right eye for select VFI variables'}, {'id': 'OG003', 'title': 'Study Midpoint - Left', 'description': 'Values of the left eye for select VFI variables'}, {'id': 'OG004', 'title': 'Study Completion - Right', 'description': 'Values of the right eye for select VFI variables'}, {'id': 'OG005', 'title': 'Study Completion - Left', 'description': 'Values of the left eye for select VFI variables'}], 'classes': [{'categories': [{'measurements': [{'value': '99.40', 'spread': '0.70', 'groupId': 'OG000'}, {'value': '99.30', 'spread': '0.82', 'groupId': 'OG001'}, {'value': '99.30', 'spread': '0.48', 'groupId': 'OG002'}, {'value': '99.50', 'spread': '0.97', 'groupId': 'OG003'}, {'value': '99.60', 'spread': '0.52', 'groupId': 'OG004'}, {'value': '99.70', 'spread': '0.48', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, at the study midpoint, and at the study completion', 'description': 'Ophthalmology studies included an assessment of visual acuity, slit lamp evaluations, and visual field testing. Retinal nerve fiber layer (RNFL) thickness and optic nerve head (ONH) were assessed using optical coherence tomography (OCT). Volunteers served as their own baseline controls for changes during the study (i.e., week 0, \\~day 45, \\~day 90).', 'unitOfMeasure': 'VFI (%)', 'dispersionType': 'Standard Deviation'}, {'type': 'SECONDARY', 'title': 'Changes in Visual Function (Mean Deviation and PSD)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Prestudy - Right', 'description': 'Values of the right eye for select VFI variables'}, {'id': 'OG001', 'title': 'Prestudy - Left', 'description': 'Values of the left eye for select VFI variables'}, {'id': 'OG002', 'title': 'Study Midpoint - Right', 'description': 'Values of the right eye for select VFI variables'}, {'id': 'OG003', 'title': 'Study Midpoint - Left', 'description': 'Values of the left eye for select VFI variables'}, {'id': 'OG004', 'title': 'Study Completion - Right', 'description': 'Values of the right eye for select VFI variables'}, {'id': 'OG005', 'title': 'Study Completion - Left', 'description': 'Values of the left eye for select VFI variables'}], 'classes': [{'title': 'Mean deviation (dB)', 'categories': [{'measurements': [{'value': '-0.22', 'spread': '1.01', 'groupId': 'OG000'}, {'value': '-0.25', 'spread': '0.78', 'groupId': 'OG001'}, {'value': '0.29', 'spread': '0.85', 'groupId': 'OG002'}, {'value': '0.02', 'spread': '0.69', 'groupId': 'OG003'}, {'value': '0.26', 'spread': '0.82', 'groupId': 'OG004'}, {'value': '-0.09', 'spread': '0.89', 'groupId': 'OG005'}]}]}, {'title': 'PSD (dB)', 'categories': [{'measurements': [{'value': '1.44', 'spread': '0.31', 'groupId': 'OG000'}, {'value': '1.38', 'spread': '0.30', 'groupId': 'OG001'}, {'value': '1.37', 'spread': '0.30', 'groupId': 'OG002'}, {'value': '1.28', 'spread': '0.13', 'groupId': 'OG003'}, {'value': '1.26', 'spread': '0.16', 'groupId': 'OG004'}, {'value': '1.26', 'spread': '0.16', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, at the study midpoint, and at the study completion', 'description': 'Ophthalmology studies included an assessment of visual acuity, slit lamp evaluations, and visual field testing. Retinal nerve fiber layer (RNFL) thickness and optic nerve head (ONH) were assessed using optical coherence tomography (OCT). Volunteers served as their own baseline controls for changes during the study (i.e., week 0, \\~day 45, \\~day 90).', 'unitOfMeasure': 'dB', 'dispersionType': 'Standard Deviation'}, {'type': 'SECONDARY', 'title': 'Changes in Neurological Function (Sural Sensory Amplitude)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Prestudy', 'description': 'Values of the sural sensory and peroneal motor variables'}, {'id': 'OG001', 'title': 'Study Midpoint', 'description': 'Values of the sural sensory and peroneal motor variables'}, {'id': 'OG002', 'title': 'Study Completion', 'description': 'Values of the sural sensory and peroneal motor variables'}, {'id': 'OG003', 'title': '1 mo Postdose', 'description': 'Values of the sural sensory and peroneal motor variables'}], 'classes': [{'categories': [{'measurements': [{'value': '24.2', 'spread': '14.8', 'groupId': 'OG000'}, {'value': '23.4', 'spread': '14.9', 'groupId': 'OG001'}, {'value': '20.7', 'spread': '12.4', 'groupId': 'OG002'}, {'value': '28.3', 'spread': '24.2', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, at the study midpoint, and at the study completion', 'description': 'Values of the sural sensory and peroneal motor variables. Volunteers served as their own baseline controls for changes during the study (i.e., week 0, \\~day 45, \\~day 90, and \\~4-6 post-weeks).', 'unitOfMeasure': 'Sural Sensory Amplitude (µV)', 'dispersionType': 'Standard Deviation', 'populationDescription': 'Participants that completed three months of cobalt supplementation'}, {'type': 'SECONDARY', 'title': 'Changes in Neurological Function (Velocity)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Prestudy', 'description': 'Values of the sural sensory and peroneal motor variables'}, {'id': 'OG001', 'title': 'Study Midpoint', 'description': 'Values of the sural sensory and peroneal motor variables'}, {'id': 'OG002', 'title': 'Study Completion', 'description': 'Values of the sural sensory and peroneal motor variables'}, {'id': 'OG003', 'title': '1 mo Postdose', 'description': 'Values of the sural sensory and peroneal motor variables'}], 'classes': [{'title': 'Sural Sensory Velocity', 'categories': [{'measurements': [{'value': '42.4', 'spread': '5.8', 'groupId': 'OG000'}, {'value': '39.9', 'spread': '7.4', 'groupId': 'OG001'}, {'value': '36.4', 'spread': '7.0', 'groupId': 'OG002'}, {'value': '43.3', 'spread': '7.8', 'groupId': 'OG003'}]}]}, {'title': 'Peroneal Motor Velocity', 'categories': [{'measurements': [{'value': '58.7', 'spread': '13.7', 'groupId': 'OG000'}, {'value': '64.1', 'spread': '18.7', 'groupId': 'OG001'}, {'value': '63.2', 'spread': '24.8', 'groupId': 'OG002'}, {'value': '0', 'spread': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, at the study midpoint, and at the study completion', 'description': 'Values of the sural sensory and peroneal motor variables. Volunteers served as their own baseline controls for changes during the study (i.e., week 0, \\~day 45, \\~day 90, and \\~4-6 post-weeks).', 'unitOfMeasure': 'm/s', 'dispersionType': 'Standard Deviation', 'populationDescription': 'Participants that completed three months of cobalt supplementation'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Study Volunteers', 'description': 'Volunteers (males and females) were instructed to take the cobalt dietary supplement in the morning according to the manufacturer\'s label, which suggested a serving of 1 mg cobalt (\\~2 mL) daily "in water or juice as maintenance." Dietary supplementation lasted for approximately three months.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}]}, {'type': 'One Month Into Study', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Study Volunteers', 'description': 'Volunteers (males and females) were instructed to take the cobalt dietary supplement in the morning according to the manufacturer\'s label, which suggested a serving of 1 mg cobalt (\\~2 mL) daily "in water or juice as maintenance." Dietary supplementation lasted for approximately three months.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'title': 'Female Age (n=8)', 'categories': [{'measurements': [{'value': '34', 'spread': '10', 'groupId': 'BG000'}]}]}, {'title': 'Male Age (n=5)', 'categories': [{'measurements': [{'value': '33', 'spread': '11', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Weight', 'classes': [{'title': 'Female weight (n=5)', 'categories': [{'measurements': [{'value': '151', 'spread': '20', 'groupId': 'BG000'}]}]}, {'title': 'Male weight (n=5)', 'categories': [{'measurements': [{'value': '219', 'spread': '53', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'pounds (lbs)', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Our pair-wise comparisons had a power of 80% to detect a mean increase in RBC count of 0.34 million (sgma =0.2 million; n=5) and a mean increase of Hgb of 0.85 g/dL (sigma =0.5 g/dL; n=5), which are less than the minimum increases detected in the males that experienced polycythemia in Davis and Fields (1958).'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'whole blood, serum and urine'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 13}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-10', 'completionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-10-03', 'studyFirstSubmitDate': '2013-11-12', 'resultsFirstSubmitDate': '2014-07-30', 'studyFirstSubmitQcDate': '2013-11-16', 'lastUpdatePostDateStruct': {'date': '2014-10-06', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-10-03', 'studyFirstPostDateStruct': {'date': '2013-11-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-10-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cobalt Whole Blood Concentrations', 'timeFrame': 'Before, during and after cobalt supplementation', 'description': 'The cobalt concentration in whole blood and serum was determined one to two weeks pre-dosing and on the day of the first day of dosing before taking the supplement. Samples were also analyzed during the dosing period as follows: Day 4/5, Day 8/9, Day 14/16, Day 22/23, Day 29/30, Day 43/44, Day 57/58, Day 71/72, and Day 88/90. Cobalt concentration in whole blood and serum was also determined at one, two, six, ten and 16 weeks post-dosing.'}, {'measure': 'Cobalt Serum Concentrations', 'timeFrame': 'Before, during and after cobalt supplementation', 'description': 'The cobalt concentration in whole blood and serum was determined one to two weeks pre-dosing and on the day of the first day of dosing before taking the supplement. Samples were also analyzed during the dosing period as follows: Day 4/5, Day 8/9, Day 14/16, Day 22/23, Day 29/30, Day 43/44, Day 57/58, Day 71/72, and Day 88/90. Cobalt concentration in whole blood and serum was also determined at one, two, six, ten and 16 weeks post-dosing.'}], 'secondaryOutcomes': [{'measure': 'Albumin Bound Cobalt Fraction in Serum', 'timeFrame': 'Study volunteers will be followed for the duration of the study, an average of about 8 months for most volunteers', 'description': 'The fraction of albumin bound cobalt in serum was determined one to two weeks pre-dosing and on the day of the first dose before taking the supplement. Samples were also analyzed during the dosing period as follows: Day 4/5, Day 8/9, Day 14/16, Day 22/23, Day 29/30, Day 43/44, Day 57/58, Day 71/72, Day 88/90 and the fraction of albumin bound cobalt in serum was also determined at one and two weeks post-dosing.'}, {'measure': 'Effects on the Immune System', 'timeFrame': '0 weeks and three months', 'description': 'Sensitivity to metals before and after cobalt supplementation was assessed by an in vitro lymphocyte transformation test (LTT) performed at week 0 and after three months of cobalt supplementation. The average proliferation rate for each metal treatment was normalized to individual proliferation rates of untreated control cells which generated a stimulation index (SI). According to the manufacture, the SI ranges from 0-15, with an SI from 2 to 4 indicated mild reactivity, from 5 to 8 indicated moderate reactivity, and \\>8 indicated high reactivity to the metal. The data is presented as the averaged normalized lymphocyte transformation response to each metal in men and women combined (n = 10).'}, {'measure': 'Hemoglobin Levels After 1, 2 and 3 Months of Dosing', 'timeFrame': 'Study volunteers were assessed before, during and after cobalt supplementation (2 wk post)', 'description': 'Blood chemistries assessed during the study included a lipid panel, comprehensive metabolic panel, creatine kinase-myocardial band, thyroid stimulating hormone, free thyroxine, and complete blood count with differential, total iron, and ferritin. Blood chemistries were assessed at one or two week pre-dose, pre-dose/ Day 1 before taking the supplement, Day 29/30, Day 57/58, Day 88/90 and one and two weeks post-dose.'}, {'measure': 'Changes in Audiological Function', 'timeFrame': 'Baseline, at the study midpoint, and at the study completion', 'description': 'Audiologic assessments including pure tone threshold determination at frequencies ranging from 250 to 16000 Hz were performed with volunteers serving as their own baseline controls for receptive changes during the study (i.e., week 0, \\~day 45, \\~day 90). Audiologic assessments including a pure-tone threshold determination at frequencies that ranged from 250 to 16000 Hz were performed with volunteers serving as their own baseline controls for receptive changes during the study. Decreases in hearing were considered clinically significant when one of the following 3 American Speech-Language-Hearing Association criteria were met: 1) a ≥20-dB decrease in the pure-tone threshold at one test frequency, 2) a ≥10-dB decrease at 2 adjacent test frequencies, or 3) the loss of 3 consecutive test frequencies where responses were previously obtained.'}, {'measure': 'Changes in Cardiac Function', 'timeFrame': 'Baseline, at the study midpoint, and at the study completion', 'description': 'Two-dimensional and Doppler echocardiographic examinations were used to assess cardiac anatomy, structure, and function during the study with volunteers serving as their own baseline controls for changes during the study (i.e., week 0, \\~day 45, \\~day 90).'}, {'measure': 'Changes in Visual Function', 'timeFrame': 'Baseline, at the study midpoint, and at the study completion', 'description': 'Ophthalmology studies included an assessment of visual acuity, slit lamp evaluations, and visual field testing. Retinal nerve fiber layer (RNFL) thickness and optic nerve head (ONH) were assessed using optical coherence tomography (OCT). Volunteers served as their own baseline controls for changes during the study (i.e., week 0, \\~day 45, \\~day 90).'}, {'measure': 'Changes in Neurological Function (Peroneal Motor Amplitude)', 'timeFrame': 'Baseline, at the study midpoint, and at the study completion', 'description': 'Values of the sural sensory and peroneal motor variables. Volunteers served as their own baseline controls for changes during the study (i.e., week 0, \\~day 45, \\~day 90, and \\~4-6 post-weeks).'}, {'measure': 'White Blood Cell (WBC) Levels After 1, 2 and 3 Months of Cobalt Dietary Supplementation', 'timeFrame': 'Study volunteers were assessed before, during and after cobalt supplementation (2 wk post)', 'description': 'Blood chemistries assessed during the study included a lipid panel, comprehensive metabolic panel, creatine kinase-myocardial band, thyroid stimulating hormone, free thyroxine, and complete blood count with differential, total iron, and ferritin. Blood chemistries were assessed at one or two week pre-dose, pre-dose/ Day 1 before taking the supplement, Day 29/30, Day 57/58, Day 88/90 and one and two weeks post-dose.'}, {'measure': 'Red Blood Cell (RBC) Levels After 1, 2 and 3 Months of Dosing', 'timeFrame': 'Study volunteers were assessed before, during and after cobalt supplementation (2 wk post)', 'description': 'Blood chemistries assessed during the study included a lipid panel, comprehensive metabolic panel, creatine kinase-myocardial band, thyroid stimulating hormone, free thyroxine, and complete blood count with differential, total iron, and ferritin. Blood chemistries were assessed at one or two week pre-dose, pre-dose/ Day 1 before taking the supplement, Day 29/30, Day 57/58, Day 88/90 and one and two weeks post-dose.'}, {'measure': 'Hematocrit Levels After 1, 2 and 3 Months of Dosing', 'timeFrame': 'Study volunteers were assessed before, during and after cobalt supplementation (2 wk post)', 'description': 'Blood chemistries assessed during the study included a lipid panel, comprehensive metabolic panel, creatine kinase-myocardial band, thyroid stimulating hormone, free thyroxine, and complete blood count with differential, total iron, and ferritin. Blood chemistries were assessed at one or two week pre-dose, pre-dose/ Day 1 before taking the supplement, Day 29/30, Day 57/58, Day 88/90 and one and two weeks post-dose.'}, {'measure': 'Protein Levels After 1, 2 and 3 Months of Dosing', 'timeFrame': 'Study volunteers were assessed before, during and after cobalt supplementation (2 wk post)', 'description': 'Blood chemistries assessed during the study included a lipid panel, comprehensive metabolic panel, creatine kinase-myocardial band, thyroid stimulating hormone, free thyroxine, and complete blood count with differential, total iron, and ferritin. Blood chemistries were assessed at one or two week pre-dose, pre-dose/ Day 1 before taking the supplement, Day 29/30, Day 57/58, Day 88/90 and one and two weeks post-dose.'}, {'measure': 'Albumin Levels After 1, 2 and 3 Months of Dosing', 'timeFrame': 'Study volunteers were assessed before, during and after cobalt supplementation (2 wk post)', 'description': 'Blood chemistries assessed during the study included a lipid panel, comprehensive metabolic panel, creatine kinase-myocardial band, thyroid stimulating hormone, free thyroxine, and complete blood count with differential, total iron, and ferritin. Blood chemistries were assessed at one or two week pre-dose, pre-dose/ Day 1 before taking the supplement, Day 29/30, Day 57/58, Day 88/90 and one and two weeks post-dose.'}, {'measure': 'Thyroid-Stimulating Hormone (TSH) Levels After 1, 2 and 3 Months of Dosing', 'timeFrame': 'Study volunteers were assessed before, during and after cobalt supplementation (2 wk post)', 'description': 'Blood chemistries assessed during the study included a lipid panel, comprehensive metabolic panel, creatine kinase-myocardial band, thyroid stimulating hormone, free thyroxine, and complete blood count with differential, total iron, and ferritin. Blood chemistries were assessed at one or two week pre-dose, pre-dose/ Day 1 before taking the supplement, Day 29/30, Day 57/58, Day 88/90 and one and two weeks post-dose.'}, {'measure': 'T4 Levels After 1, 2 and 3 Months of Dosing', 'timeFrame': 'Study volunteers were assessed before, during and after cobalt supplementation (2 wk post)', 'description': 'Blood chemistries assessed during the study included a lipid panel, comprehensive metabolic panel, creatine kinase-myocardial band, thyroid stimulating hormone, free thyroxine, and complete blood count with differential, total iron, and ferritin. Blood chemistries were assessed at one or two week pre-dose, pre-dose/ Day 1 before taking the supplement, Day 29/30, Day 57/58, Day 88/90 and one and two weeks post-dose.'}, {'measure': 'Total Iron Levels After 1, 2 and 3 Months of Dosing', 'timeFrame': 'Study volunteers were assessed before, during and after cobalt supplementation (2 wk post)', 'description': 'Blood chemistries assessed during the study included a lipid panel, comprehensive metabolic panel, creatine kinase-myocardial band, thyroid stimulating hormone, free thyroxine, and complete blood count with differential, total iron, and ferritin. Blood chemistries were assessed at one or two week pre-dose, pre-dose/ Day 1 before taking the supplement, Day 29/30, Day 57/58, Day 88/90 and one and two weeks post-dose.'}, {'measure': 'Ferritin Levels After 1, 2 and 3 Months of Dosing', 'timeFrame': 'Study volunteers were assessed before, during and after cobalt supplementation (2 wk post)', 'description': 'Blood chemistries assessed during the study included a lipid panel, comprehensive metabolic panel, creatine kinase-myocardial band, thyroid stimulating hormone, free thyroxine, and complete blood count with differential, total iron, and ferritin. Blood chemistries were assessed at one or two week pre-dose, pre-dose/ Day 1 before taking the supplement, Day 29/30, Day 57/58, Day 88/90 and one and two weeks post-dose.'}, {'measure': 'Creatine Creatine Kinase-Myocardial Band (CK-MB) Levels After 1, 2 and 3 Months of Dosing', 'timeFrame': 'Study volunteers were assessed before, during and after cobalt supplementation (2 wk post)', 'description': 'Blood chemistries assessed during the study included a lipid panel, comprehensive metabolic panel, creatine kinase-myocardial band, thyroid stimulating hormone, free thyroxine, and complete blood count with differential, total iron, and ferritin. Blood chemistries were assessed at one or two week pre-dose, pre-dose/ Day 1 before taking the supplement, Day 29/30, Day 57/58, Day 88/90 and one and two weeks post-dose.'}, {'measure': 'Creatinine Levels After 1, 2 and 3 Months of Dosing', 'timeFrame': 'Study volunteers were assessed before, during and after cobalt supplementation (2 wk post)', 'description': 'Blood chemistries assessed during the study included a lipid panel, comprehensive metabolic panel, creatine kinase-myocardial band, thyroid stimulating hormone, free thyroxine, and complete blood count with differential, total iron, and ferritin. Blood chemistries were assessed at one or two week pre-dose, pre-dose/ Day 1 before taking the supplement, Day 29/30, Day 57/58, Day 88/90 and one and two weeks post-dose.'}, {'measure': 'Alanine Aminotransferase (ALT) Levels After 1, 2 and 3 Months of Dosing', 'timeFrame': 'Study volunteers were assessed before, during and after cobalt supplementation (2 wk post)', 'description': 'Blood chemistries assessed during the study included a lipid panel, comprehensive metabolic panel, creatine kinase-myocardial band, thyroid stimulating hormone, free thyroxine, and complete blood count with differential, total iron, and ferritin. Blood chemistries were assessed at one or two week pre-dose, pre-dose/ Day 1 before taking the supplement, Day 29/30, Day 57/58, Day 88/90 and one and two weeks post-dose.'}, {'measure': 'Aspartate Aminotransferase (AST) Levels After 1, 2 and 3 Months of Dosing', 'timeFrame': 'Study volunteers were assessed before, during and after cobalt supplementation (2 wk post)', 'description': 'Blood chemistries assessed during the study included a lipid panel, comprehensive metabolic panel, creatine kinase-myocardial band, thyroid stimulating hormone, free thyroxine, and complete blood count with differential, total iron, and ferritin. Blood chemistries were assessed at one or two week pre-dose, pre-dose/ Day 1 before taking the supplement, Day 29/30, Day 57/58, Day 88/90 and one and two weeks post-dose.'}, {'measure': 'HDL Cholesterol Levels After 3 Months of Cobalt Supplementation', 'timeFrame': 'Study volunteers were assessed before and at the end of cobalt supplementation', 'description': 'Blood chemistries assessed during the study included a lipid panel, comprehensive metabolic panel, creatine kinase-myocardial band, thyroid stimulating hormone, free thyroxine, and complete blood count with differential, total iron, and ferritin. HDL cholesterol levels were assessed before cobalt dietary supplementation and after three months of supplementation.'}, {'measure': 'Total Cholesterol Levels After 3 Months of Cobalt Supplementation', 'timeFrame': 'Study volunteers were assessed before and at the end of cobalt supplementation', 'description': 'Blood chemistries assessed during the study included a lipid panel, comprehensive metabolic panel, creatine kinase-myocardial band, thyroid stimulating hormone, free thyroxine, and complete blood count with differential, total iron, and ferritin. Total cholesterol levels were assessed before cobalt dietary supplementation and after three months of supplementation.'}, {'measure': 'Triglyceride Levels After 3 Months of Cobalt Supplementation', 'timeFrame': 'Study volunteers were assessed before and at the end of cobalt supplementation', 'description': 'Blood chemistries assessed during the study included a lipid panel, comprehensive metabolic panel, creatine kinase-myocardial band, thyroid stimulating hormone, free thyroxine, and complete blood count with differential, total iron, and ferritin. Triglyceride levels were assessed before cobalt dietary supplementation and after three months of supplementation.'}, {'measure': 'Glucose Levels After 1, 2 and 3 Months of Dosing', 'timeFrame': 'Study volunteers were assessed before, during and after cobalt supplementation (2 wk post)', 'description': 'Blood chemistries assessed during the study included a lipid panel, comprehensive metabolic panel, creatine kinase-myocardial band, thyroid stimulating hormone, free thyroxine, and complete blood count with differential, total iron, and ferritin. Blood chemistries were assessed at one or two week pre-dose, pre-dose/ Day 1 before taking the supplement, Day 29/30, Day 57/58, Day 88/90 and one and two weeks post-dose.'}, {'measure': 'Cobalt Urine Concentrations', 'timeFrame': 'During cobalt supplementation', 'description': 'A 24 hr urine collection for cobalt analysis was performed at Day 14/16, Day 43/44 and Day 88/90.'}, {'measure': 'Cobalt Urine Concentrations After Cessation of Cobalt Supplementation', 'timeFrame': 'After cobalt supplementation', 'description': 'A 24 hr urine collection for cobalt analysis was performed on three volunteers (two females and one male) at one, two, six and ten weeks post-dosing. The one male volunteer provided three consecutive 24-hr urine samples at the one and two week post-dosing time points; data for individual urine collections were averaged together to give an average one and two week post-dosing data concentration.'}, {'measure': 'Changes in Cardiac Function (LVEF)', 'timeFrame': 'Baseline, at the study midpoint, and at the study completion', 'description': 'Two-dimensional and Doppler echocardiographic examinations were used to assess cardiac anatomy, structure, and function during the study with volunteers serving as their own baseline controls for changes during the study (i.e., week 0, \\~day 45, \\~day 90).'}, {'measure': 'Changes in Cardiac Function (LA Volume Index)', 'timeFrame': 'Baseline, at the study midpoint, and at the study completion', 'description': 'Two-dimensional and Doppler echocardiographic examinations were used to assess cardiac anatomy, structure, and function during the study with volunteers serving as their own baseline controls for changes during the study (i.e., week 0, \\~day 45, \\~day 90).'}, {'measure': 'Changes in Visual Function (Average RNFL Thickness)', 'timeFrame': 'Baseline, at the study midpoint, and at the study completion', 'description': 'Ophthalmology studies included an assessment of visual acuity, slit lamp evaluations, and visual field testing. Retinal nerve fiber layer (RNFL) thickness and optic nerve head (ONH) were assessed using optical coherence tomography (OCT). Volunteers served as their own baseline controls for changes during the study (i.e., week 0, \\~day 45, \\~day 90).'}, {'measure': 'Changes in Visual Function (Average C:D Ratio)', 'timeFrame': 'Baseline, at the study midpoint, and at the study completion', 'description': 'Ophthalmology studies included an assessment of visual acuity, slit lamp evaluations, and visual field testing. Retinal nerve fiber layer (RNFL) thickness and optic nerve head (ONH) were assessed using optical coherence tomography (OCT). Volunteers served as their own baseline controls for changes during the study (i.e., week 0, \\~day 45, \\~day 90).'}, {'measure': 'Changes in Visual Function (Cup Volume)', 'timeFrame': 'Baseline, at the study midpoint, and at the study completion', 'description': 'Ophthalmology studies included an assessment of visual acuity, slit lamp evaluations, and visual field testing. Retinal nerve fiber layer (RNFL) thickness and optic nerve head (ONH) were assessed using optical coherence tomography (OCT). Volunteers served as their own baseline controls for changes during the study (i.e., week 0, \\~day 45, \\~day 90).'}, {'measure': 'Changes in Visual Function (VFI)', 'timeFrame': 'Baseline, at the study midpoint, and at the study completion', 'description': 'Ophthalmology studies included an assessment of visual acuity, slit lamp evaluations, and visual field testing. Retinal nerve fiber layer (RNFL) thickness and optic nerve head (ONH) were assessed using optical coherence tomography (OCT). Volunteers served as their own baseline controls for changes during the study (i.e., week 0, \\~day 45, \\~day 90).'}, {'measure': 'Changes in Visual Function (Mean Deviation and PSD)', 'timeFrame': 'Baseline, at the study midpoint, and at the study completion', 'description': 'Ophthalmology studies included an assessment of visual acuity, slit lamp evaluations, and visual field testing. Retinal nerve fiber layer (RNFL) thickness and optic nerve head (ONH) were assessed using optical coherence tomography (OCT). Volunteers served as their own baseline controls for changes during the study (i.e., week 0, \\~day 45, \\~day 90).'}, {'measure': 'Changes in Neurological Function (Sural Sensory Amplitude)', 'timeFrame': 'Baseline, at the study midpoint, and at the study completion', 'description': 'Values of the sural sensory and peroneal motor variables. Volunteers served as their own baseline controls for changes during the study (i.e., week 0, \\~day 45, \\~day 90, and \\~4-6 post-weeks).'}, {'measure': 'Changes in Neurological Function (Velocity)', 'timeFrame': 'Baseline, at the study midpoint, and at the study completion', 'description': 'Values of the sural sensory and peroneal motor variables. Volunteers served as their own baseline controls for changes during the study (i.e., week 0, \\~day 45, \\~day 90, and \\~4-6 post-weeks).'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Cobalt', 'Dietary Supplements', 'Hematological', 'Thyroid'], 'conditions': ['Cobalt Biokinetics', 'Safety of Cobalt Dietary Supplementation']}, 'referencesModule': {'references': [{'pmid': '24500148', 'type': 'DERIVED', 'citation': 'Tvermoes BE, Unice KM, Paustenbach DJ, Finley BL, Otani JM, Galbraith DA. Effects and blood concentrations of cobalt after ingestion of 1 mg/d by human volunteers for 90 d. Am J Clin Nutr. 2014 Mar;99(3):632-46. doi: 10.3945/ajcn.113.071449. Epub 2014 Feb 5.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate steady-state cobalt levels following dietary supplementation for 90 days with 1 mg cobalt/day (as cobalt chloride in solution) in healthy adult volunteers.', 'detailedDescription': "Over the counter cobalt (Co) dietary supplements are available for sale in the United States, but little is known regarding their clinical effects and biokinetic distribution and body burden with long-term use. This study assessed blood kinetics, steady-state levels, biochemical responses, and clinical effects in five adult males and five adult females who voluntarily ingested approximately 1.0 mg Co/day of a commercially available Co supplement over a three month period. Volunteers were instructed to take the Co-dietary supplement in the morning according to the manufacturer's label. Blood samples were collected and analyzed for a number of biochemical parameters before, during, and after dosing. Hearing, vision, cardiac, and neurological functions were also assessed in volunteers before, during, and after dosing."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy adult volunteers from work site and off work site', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subject ≥ 18 years old.\n* Subject able to understand and willing to sign a written informed consent form for the study.\n\nExclusion Criteria:\n\n* Subject is unwilling to discontinue current multivitamins or other types of dietary supplements while on study\n* Subject has a documented history of an allergy to cobalt\n* Subject has a documented history of severe cardiac problems (e.g., congestive heart failure, myocardial ischemia within past 12 months, cardiomyopathy)\n* Subject has a documented history of thyroid, kidney, or liver disease\n* Subject has insulin-dependent diabetes\n* Subject has a concurrent illness or personal stressor which in the opinion of the investigator may interfere with the subject's ability to perform the study's requirements.\n* Subject has a total joint replacement (e.g., knee, hip, shoulder)\n* Subject is pregnant or breastfeeding\n* Subject is unwilling to follow protocol requirements\n* Subject weight is less than 45 kg"}, 'identificationModule': {'nctId': 'NCT01990794', 'briefTitle': '90-Day Cobalt Supplementation Study to Investigate the Cobalt Body Burden in Ten Healthy Adult Volunteers', 'organization': {'class': 'OTHER', 'fullName': 'Cardno ChemRisk'}, 'officialTitle': 'A 90-Day Cobalt Supplementation Study to Investigate the Cobalt Body Burden in Ten Healthy Adult Volunteers', 'orgStudyIdInfo': {'id': 'CR103'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Study Volunteers', 'description': 'Volunteers (males and females) were instructed to take the cobalt dietary supplement in the morning according to the manufacturer\'s label, which suggested a serving of 1 mg cobalt (\\~2 mL) daily "in water or juice as maintenance." Dietary supplementation lasted for approximately three months.'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'David Galbraith, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cardno ChemRisk'}, {'name': 'David Galbraith, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Cardno ChemRisk'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cardno ChemRisk', 'class': 'OTHER'}, 'collaborators': [{'name': 'DePuy Orthopaedics', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}