Ignite Creation Date:
2025-12-24 @ 9:58 PM
Ignite Modification Date:
2026-03-12 @ 6:25 AM
Study NCT ID:
NCT01876732
Status:
COMPLETED
Last Update Posted:
2014-09-08
First Post:
2013-05-14
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Impact of Vitamin B12 Replacement on Epogen Dosing and Improvement of Quality of Life in Hemodialysis Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014806', 'term': 'Vitamin B 12 Deficiency'}], 'ancestors': [{'id': 'D014804', 'term': 'Vitamin B Deficiency'}, {'id': 'D001361', 'term': 'Avitaminosis'}, {'id': 'D003677', 'term': 'Deficiency Diseases'}, {'id': 'D044342', 'term': 'Malnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014805', 'term': 'Vitamin B 12'}], 'ancestors': [{'id': 'D045728', 'term': 'Corrinoids'}, {'id': 'D045725', 'term': 'Tetrapyrroles'}, {'id': 'D011758', 'term': 'Pyrroles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D047028', 'term': 'Macrocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'uviola@siuh.edu', 'phone': '718-226-6158', 'title': 'Suzanne El-Sayegh', 'organization': 'Staten Island University Hospital'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'There were too few patients with MMA levels over 800 to determine sensitivity.'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Vitamin B12', 'description': 'Those with an MMA over 800nmol/L are given 1000mcg of IM vitamin B12 weekly for the first month and then monthly for 3 consecutive months.\n\nVitamin B12: Consented subjects are screened for Vitamin B12 deficiency with measurements of serum vitamin B12 concentrations and plasma levels of MMA, drawn prior to the first HD session of the week. Those with an MMA over 800nmol/L are given 1000mcg of IM vitamin B12 weekly for the first month and then monthly for 3 consecutive months. Following therapy, serum B12, MMA levels, percent iron saturation, parathyroid levels and peripheral blood smear are to be repeated and compared to previous levels. Subjects also complete a KDQOL-36 prior to therapy and again post treatment.', 'otherNumAtRisk': 57, 'otherNumAffected': 0, 'seriousNumAtRisk': 57, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Amount of Epogen Required', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Vitamin B12', 'description': 'Those with an MMA over 800nmol/L are given 1000mcg of IM vitamin B12 weekly for the first month and then monthly for 3 consecutive months.\n\nVitamin B12: Consented subjects are screened for Vitamin B12 deficiency with measurements of serum vitamin B12 concentrations and plasma levels of MMA, drawn prior to the first HD session of the week. Those with an MMA over 800nmol/L are given 1000mcg of IM vitamin B12 weekly for the first month and then monthly for 3 consecutive months. Following therapy, serum B12, MMA levels, percent iron saturation, parathyroid levels and peripheral blood smear are to be repeated and compared to previous levels. Subjects also complete a KDQOL-36 prior to therapy and again post treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '-16,572', 'spread': '41,902', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 4 months', 'description': 'The effects of Vitamin B12 supplementation on erythropoitin alpha (Epogen) requirements in HD patients', 'unitOfMeasure': 'unit/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Quality of Life', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Vitamin B12', 'description': 'Those with an methylmalonic acid (MMA) over 800nmol/L are given 1000mcg of intramuscular (IM) vitamin B12 weekly for the first month and then monthly for 3 consecutive months.\n\nVitamin B 12: Consented subjects are screened for Vitamin B12 deficiency with measurements of serum vitamin B12 concentrations and plasma levels of MMA, drawn prior to the first hemodialysis (HD) session of the week. Those with an MMA over 800nmol/L are given 1000mcg of IM vitamin B12 weekly for the first month and then monthly for 3 consecutive months. Following therapy, serum B12, MMA levels, percent iron saturation, parathyroid levels and peripheral blood smear are to be repeated and compared to previous levels. Subjects also complete a Kidney Disease Quality of Life- 36 (KDQOL-36) prior to therapy and again post treatment.'}], 'classes': [{'title': 'Social Function (pre-test)', 'categories': [{'measurements': [{'value': '56.67', 'spread': '29.07', 'groupId': 'OG000'}]}]}, {'title': 'Social Function (post-test)', 'categories': [{'measurements': [{'value': '67.50', 'spread': '24.91', 'groupId': 'OG000'}]}]}, {'title': 'Symptom/problem list (pre-test)', 'categories': [{'measurements': [{'value': '76.62', 'spread': '18.60', 'groupId': 'OG000'}]}]}, {'title': 'Symptom/problem list (post-test)', 'categories': [{'measurements': [{'value': '75.69', 'spread': '19.98', 'groupId': 'OG000'}]}]}, {'title': 'Effects of kidney disease (pre-test)', 'categories': [{'measurements': [{'value': '52.29', 'spread': '26.08', 'groupId': 'OG000'}]}]}, {'title': 'Effects of kidney disease (post-test)', 'categories': [{'measurements': [{'value': '54.58', 'spread': '26.96', 'groupId': 'OG000'}]}]}, {'title': 'Burden of kidney disease pre-test', 'categories': [{'measurements': [{'value': '43.75', 'spread': '31.25', 'groupId': 'OG000'}]}]}, {'title': 'Burden of kidney disease (post-test)', 'categories': [{'measurements': [{'value': '37.50', 'spread': '29.60', 'groupId': 'OG000'}]}]}, {'title': 'Work status (pre-test)', 'categories': [{'measurements': [{'value': '26.67', 'spread': '32.00', 'groupId': 'OG000'}]}]}, {'title': 'Work status (post-test)', 'categories': [{'measurements': [{'value': '16.67', 'spread': '30.86', 'groupId': 'OG000'}]}]}, {'title': 'Cognitive function (pre-test)', 'categories': [{'measurements': [{'value': '71.11', 'spread': '28.91', 'groupId': 'OG000'}]}]}, {'title': 'Cognitive function (post-test)', 'categories': [{'measurements': [{'value': '72.44', 'spread': '29.26', 'groupId': 'OG000'}]}]}, {'title': 'Quality of social interaction (pre-test)', 'categories': [{'measurements': [{'value': '70.67', 'spread': '26.04', 'groupId': 'OG000'}]}]}, {'title': 'Quality of social interaction (post-test)', 'categories': [{'measurements': [{'value': '79.11', 'spread': '18.15', 'groupId': 'OG000'}]}]}, {'title': 'Sexual function (pre-test)', 'categories': [{'measurements': [{'value': '87.50', 'spread': '17.68', 'groupId': 'OG000'}]}]}, {'title': 'Sexual function (post-test)', 'categories': [{'measurements': [{'value': '100.00', 'spread': '0.00', 'groupId': 'OG000'}]}]}, {'title': 'Sleep (pre-test)', 'categories': [{'measurements': [{'value': '51.00', 'spread': '23.81', 'groupId': 'OG000'}]}]}, {'title': 'Sleep (post-test)', 'categories': [{'measurements': [{'value': '51.33', 'spread': '24.03', 'groupId': 'OG000'}]}]}, {'title': 'Social support (pre-test)', 'categories': [{'measurements': [{'value': '77.78', 'spread': '32.53', 'groupId': 'OG000'}]}]}, {'title': 'Social support (post-test)', 'categories': [{'measurements': [{'value': '77.78', 'spread': '29.99', 'groupId': 'OG000'}]}]}, {'title': 'Dialysis staff encouragement (pre-test)', 'categories': [{'measurements': [{'value': '83.33', 'spread': '15.43', 'groupId': 'OG000'}]}]}, {'title': 'Dialysis staff encouragement (post-test)', 'categories': [{'measurements': [{'value': '82.50', 'spread': '16.90', 'groupId': 'OG000'}]}]}, {'title': 'Overall health (pre-test)', 'categories': [{'measurements': [{'value': '54.67', 'spread': '24.46', 'groupId': 'OG000'}]}]}, {'title': 'Overall health (post-test)', 'categories': [{'measurements': [{'value': '60.00', 'spread': '27.77', 'groupId': 'OG000'}]}]}, {'title': 'Patient satisfaction (pre-test)', 'categories': [{'measurements': [{'value': '71.11', 'spread': '22.24', 'groupId': 'OG000'}]}]}, {'title': 'Patient satisfaction (post-test)', 'categories': [{'measurements': [{'value': '62.22', 'spread': '17.21', 'groupId': 'OG000'}]}]}, {'title': 'Physical functioning (pre-test)', 'categories': [{'measurements': [{'value': '39.33', 'spread': '30.41', 'groupId': 'OG000'}]}]}, {'title': 'Physical functioning (post-test)', 'categories': [{'measurements': [{'value': '37.00', 'spread': '27.37', 'groupId': 'OG000'}]}]}, {'title': 'Role-physical (pre-test)', 'categories': [{'measurements': [{'value': '28.33', 'spread': '38.81', 'groupId': 'OG000'}]}]}, {'title': 'Role-physical (post-test)', 'categories': [{'measurements': [{'value': '40.00', 'spread': '40.97', 'groupId': 'OG000'}]}]}, {'title': 'Pain (pre-test)', 'categories': [{'measurements': [{'value': '55.83', 'spread': '36.57', 'groupId': 'OG000'}]}]}, {'title': 'Pain (post-test)', 'categories': [{'measurements': [{'value': '65.83', 'spread': '33.54', 'groupId': 'OG000'}]}]}, {'title': 'General health (pre-test)', 'categories': [{'measurements': [{'value': '36.92', 'spread': '17.97', 'groupId': 'OG000'}]}]}, {'title': 'General health (post-test)', 'categories': [{'measurements': [{'value': '44.33', 'spread': '24.56', 'groupId': 'OG000'}]}]}, {'title': 'Emotional well-being (pre-test)', 'categories': [{'measurements': [{'value': '68.00', 'spread': '21.43', 'groupId': 'OG000'}]}]}, {'title': 'Emotional well-being (post-test)', 'categories': [{'measurements': [{'value': '64.00', 'spread': '20.51', 'groupId': 'OG000'}]}]}, {'title': 'Role-emotional (pre-test)', 'categories': [{'measurements': [{'value': '35.56', 'spread': '44.48', 'groupId': 'OG000'}]}]}, {'title': 'Role-emotional (post-test)', 'categories': [{'measurements': [{'value': '55.56', 'spread': '46.58', 'groupId': 'OG000'}]}]}, {'title': 'Energy/fatigue (pre-test)', 'categories': [{'measurements': [{'value': '40.33', 'spread': '27.48', 'groupId': 'OG000'}]}]}, {'title': 'Energy/fatigue (post-test)', 'categories': [{'measurements': [{'value': '48.00', 'spread': '17.61', 'groupId': 'OG000'}]}]}, {'title': 'SF-12 physical composite (pre-test)', 'categories': [{'measurements': [{'value': '34.06', 'spread': '8.81', 'groupId': 'OG000'}]}]}, {'title': 'SF-12 physical composite (post-test)', 'categories': [{'measurements': [{'value': '36.12', 'spread': '9.44', 'groupId': 'OG000'}]}]}, {'title': 'SF-12 mental composite (pre-test)', 'categories': [{'measurements': [{'value': '41.88', 'spread': '11.45', 'groupId': 'OG000'}]}]}, {'title': 'SF-12 mental composite (post-test)', 'categories': [{'measurements': [{'value': '44.83', 'spread': '11.18', 'groupId': 'OG000'}]}]}, {'title': 'Social function (pre to post change)', 'categories': [{'measurements': [{'value': '10.83', 'spread': '19.40', 'groupId': 'OG000'}]}]}, {'title': 'Symptom/problem list (pre to post change)', 'categories': [{'measurements': [{'value': '-3.13', 'spread': '14.72', 'groupId': 'OG000'}]}]}, {'title': 'Effects of kidney disease (pre to post change)', 'categories': [{'measurements': [{'value': '2.29', 'spread': '9.99', 'groupId': 'OG000'}]}]}, {'title': 'Burden of kidney disease (pre to post change)', 'categories': [{'measurements': [{'value': '-6.25', 'spread': '17.52', 'groupId': 'OG000'}]}]}, {'title': 'Work status (pre to post change)', 'categories': [{'measurements': [{'value': '-10.00', 'spread': '20.70', 'groupId': 'OG000'}]}]}, {'title': 'Cognitive function (pre to post change)', 'categories': [{'measurements': [{'value': '1.33', 'spread': '28.75', 'groupId': 'OG000'}]}]}, {'title': 'Quality of social interaction (pre to post change)', 'categories': [{'measurements': [{'value': '8.44', 'spread': '25.63', 'groupId': 'OG000'}]}]}, {'title': 'Sleep (pre to post change)', 'categories': [{'measurements': [{'value': '0.33', 'spread': '20.81', 'groupId': 'OG000'}]}]}, {'title': 'Social support (pre to post change)', 'categories': [{'measurements': [{'value': '0.00', 'spread': '39.34', 'groupId': 'OG000'}]}]}, {'title': 'Dialysis staff encouragement (pre to post change)', 'categories': [{'measurements': [{'value': '-0.83', 'spread': '21.89', 'groupId': 'OG000'}]}]}, {'title': 'Overall health (pre to post change)', 'categories': [{'measurements': [{'value': '5.33', 'spread': '19.95', 'groupId': 'OG000'}]}]}, {'title': 'Patient satisfaction (pre to post change)', 'categories': [{'measurements': [{'value': '-8.89', 'spread': '15.26', 'groupId': 'OG000'}]}]}, {'title': 'Physical functioning (pre to post change)', 'categories': [{'measurements': [{'value': '-2.33', 'spread': '17.10', 'groupId': 'OG000'}]}]}, {'title': 'Role-physical (pre to post change)', 'categories': [{'measurements': [{'value': '11.67', 'spread': '43.16', 'groupId': 'OG000'}]}]}, {'title': 'Pain (pre to post change)', 'categories': [{'measurements': [{'value': '10.00', 'spread': '36.29', 'groupId': 'OG000'}]}]}, {'title': 'General health (pre to post change)', 'categories': [{'measurements': [{'value': '7.42', 'spread': '15.81', 'groupId': 'OG000'}]}]}, {'title': 'Emotional well-being (pre to post change)', 'categories': [{'measurements': [{'value': '-4.00', 'spread': '23.71', 'groupId': 'OG000'}]}]}, {'title': 'Role-emotional (pre to post change)', 'categories': [{'measurements': [{'value': '20.00', 'spread': '46.80', 'groupId': 'OG000'}]}]}, {'title': 'Energy/fatigue (pre to post change)', 'categories': [{'measurements': [{'value': '7.67', 'spread': '21.29', 'groupId': 'OG000'}]}]}, {'title': 'SF-12 physical composite (pre to post change)', 'categories': [{'measurements': [{'value': '2.06', 'spread': '8.63', 'groupId': 'OG000'}]}]}, {'title': 'SF-12 mental composite (pre to post change)', 'categories': [{'measurements': [{'value': '2.94', 'spread': '9.84', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.047', 'groupIds': ['OG000'], 'pValueComment': 'P- value for "social function"', 'statisticalMethod': 'Wilcoxon signed-rank test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.688', 'groupIds': ['OG000'], 'pValueComment': 'P- value of " symptom/problem list "', 'statisticalMethod': 'Wilcoxon signed-rank test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.772', 'groupIds': ['OG000'], 'pValueComment': 'P- value of " effects of kidney disease "', 'statisticalMethod': 'Wilcoxon signed-rank test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.301', 'groupIds': ['OG000'], 'pValueComment': 'P-value of " burden of kidney disease "', 'statisticalMethod': 'Wilcoxon signed-rank test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.250', 'groupIds': ['OG000'], 'pValueComment': 'P-value of " work status "', 'statisticalMethod': 'Wilcoxon signed-rank test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.895', 'groupIds': ['OG000'], 'pValueComment': 'P-value of " cognitive function "', 'statisticalMethod': 'Wilcoxon signed-rank test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.281', 'groupIds': ['OG000'], 'pValueComment': 'P-value of " quality of social interaction "', 'statisticalMethod': 'Wilcoxon signed-rank test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '1.00', 'groupIds': ['OG000'], 'pValueComment': 'P-value of " sleep "', 'statisticalMethod': 'Wilcoxon signed-rank test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '1.00', 'groupIds': ['OG000'], 'pValueComment': 'P-value of " social support "', 'statisticalMethod': 'Wilcoxon signed-rank test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.943', 'groupIds': ['OG000'], 'pValueComment': 'P-value of " dialysis staff encouragement "', 'statisticalMethod': 'Wilcoxon signed-rank test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '1.00', 'groupIds': ['OG000'], 'pValueComment': 'P-value of " overall health "', 'statisticalMethod': 'Wilcoxon signed-rank test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.090', 'groupIds': ['OG000'], 'pValueComment': 'P-value of " patient satisfaction "', 'statisticalMethod': 'Wilcoxon signed-rank test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.391', 'groupIds': ['OG000'], 'pValueComment': 'P-value of " physical functioning "', 'statisticalMethod': 'Wilcoxon signed-rank test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.438', 'groupIds': ['OG000'], 'pValueComment': 'P-value of " role-physical "', 'statisticalMethod': 'Wilcoxon signed-rank test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.424', 'groupIds': ['OG000'], 'pValueComment': 'P-value of " pain "', 'statisticalMethod': 'Wilcoxon signed-rank test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.169', 'groupIds': ['OG000'], 'pValueComment': 'P-value of " general health "', 'statisticalMethod': 'Wilcoxon signed-rank test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.858', 'groupIds': ['OG000'], 'pValueComment': 'P-value of " emotional well-being "', 'statisticalMethod': 'Wilcoxon signed-rank test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.156', 'groupIds': ['OG000'], 'pValueComment': 'P-value of " role-emotional "', 'statisticalMethod': 'Wilcoxon signed-rank test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.084', 'groupIds': ['OG000'], 'pValueComment': 'P-value of " energy/fatigue "', 'statisticalMethod': 'Wilcoxon signed-rank test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.583', 'groupIds': ['OG000'], 'pValueComment': 'P-value of " SF-12 physical composite "', 'statisticalMethod': 'Wilcoxon signed-rank test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.358', 'groupIds': ['OG000'], 'pValueComment': 'p-value of " SF-12 mental composite "', 'statisticalMethod': 'Wilcoxon signed-rank test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '3 month', 'description': 'The scoring procedure for the KDQOL-36 (Kidney Disease Quality of Life Instrument adopted for quality of life assessment of patients with kidney disease),first transforms the raw precoded numeric values of items to a 0-100 possible range with higher transformed scores reflecting a better quality of life. Each item is put on a 0 to100 range so that the lowest and highest possible scores are set at 0 and100, respectively. The results entered in the outcome data is the mean absolute difference between the mean pre-test score and the mean post-test score.', 'unitOfMeasure': 'Scores on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects were asked to complete a KDQOL-36 (Kidney Disease Quality of Life Instrument adopted for quality of life assessment of patients with kidney disease), once prior to therapy, and then again at the end of 3 months when therapy (when therapy is completed), was completed. Pre and post results will be compared.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Vitamin B12', 'description': 'Those with an methylmalonic acid (MMA) over 800nmol/L are given 1000mcg of intramuscular (IM) vitamin B12 weekly for the first month and then monthly for 3 consecutive months.\n\nVitamin B 12: Consented subjects are screened for Vitamin B12 deficiency with measurements of serum vitamin B12 concentrations and plasma levels of MMA, drawn prior to the first hemodialysis (HD) session of the week. Those with an MMA over 800nmol/L are given 1000mcg of IM vitamin B12 weekly for the first month and then monthly for 3 consecutive months. Following therapy, serum B12, MMA levels, percent iron saturation, parathyroid levels and peripheral blood smear are to be repeated and compared to previous levels. Subjects also complete a Kidney Disease Quality of Life- 36 (KDQOL-36) prior to therapy and again post treatment.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '132'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '57'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '75'}]}], 'dropWithdraws': [{'type': 'MMA was not over 800mg/dL', 'reasons': [{'groupId': 'FG000', 'numSubjects': '75'}]}]}], 'recruitmentDetails': 'Those with an MMA over 800nmol/L are given 1000mcg of IM vitamin B12 weekly for the first month and then monthly for 3 consecutive months.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Vitamin B12', 'description': 'Those with an MMA over 800nmol/L are given 1000mcg of IM vitamin B12 weekly for the first month and then monthly for 3 consecutive months.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '50', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'From a single center dialysis unit, patients 18-80 on hemodialysis at least 6 months and taking Epogen were screened for serum Vitamin B12 levels and plasma MMA. Those with an MMA level greater than 800mmol/L had smears of their peripheral blood examined to assess for characteristic findings that are consistent with vitamin B12 deficiency.', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '63.43', 'spread': '14.6', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '34', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '23', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '57', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 132}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-09', 'completionDateStruct': {'date': '2011-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-09-05', 'studyFirstSubmitDate': '2013-05-14', 'resultsFirstSubmitDate': '2014-02-06', 'studyFirstSubmitQcDate': '2013-06-10', 'lastUpdatePostDateStruct': {'date': '2014-09-08', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-09-05', 'studyFirstPostDateStruct': {'date': '2013-06-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-09-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Amount of Epogen Required', 'timeFrame': 'Baseline and 4 months', 'description': 'The effects of Vitamin B12 supplementation on erythropoitin alpha (Epogen) requirements in HD patients'}], 'secondaryOutcomes': [{'measure': 'Change in Quality of Life', 'timeFrame': '3 month', 'description': 'The scoring procedure for the KDQOL-36 (Kidney Disease Quality of Life Instrument adopted for quality of life assessment of patients with kidney disease),first transforms the raw precoded numeric values of items to a 0-100 possible range with higher transformed scores reflecting a better quality of life. Each item is put on a 0 to100 range so that the lowest and highest possible scores are set at 0 and100, respectively. The results entered in the outcome data is the mean absolute difference between the mean pre-test score and the mean post-test score.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['hemodialysis', 'viatmin B12 deficiency', 'Epogen'], 'conditions': ['Vitamin B12 Deficiency']}, 'descriptionModule': {'briefSummary': 'Vitamin B12 has several important functions in the body, two of which are production of red blood cells and the maintenance of a healthy nervous system. When vitamin B12 is deficient, abnormal red blood cells form. These cells are called megaloblasts. The end result is a decreased number of red blood cells; a condition called anemia. Some symptoms of anemia include fatigue, weakness, shortness of breath, and pallor. Vitamin B12 is also important in maintaining a healthy nervous system. Nerves are surrounded by an insulating material that helps them conduct impulses. Patients with low B12 levels who receive this vitamin in injection form, state that there quality of life is better. Anemia in Hemodialysis patients is treated with Epogen, a synthetic material which helps your body make blood cells. The investigators believe that if you have a low vitamin B12 level in your blood and the investigators give you the vitamin during dialysis your requirement for epogen will be lower and you will be able to produce blood cells better. When evaluating for Vitamin B12 deficiency a special test is needed called methylmalonic acid level (MMA). This is a blood test that will be performed and when this level is high and your vitamin B12 level is in the low normal range the investigators can make a diagnosis of vitamin B12 deficiency.', 'detailedDescription': 'BACKGROUND: Vitamin B12 deficiency may have deleterious effects on end stage renal disease (ESRD) patients on maintenance hemodialysis, and may increase erythropoietin stimulating agent (ESA) resistance, yet little is known about its prevalence in this population.\n\nMETHODS: Serum vitamin B12 and methylmalonic acid (MMA) levels were drawn from ESRD patients prior to hemodialysis. All patients with MMA levels greater than 800 nmol/L had peripheral smears evaluated for B12 deficiency. Those with confirmatory smears were considered to be deficient and received intramuscular vitamin B12 injections for 4 months. Post-treatment MMA levels and smears were obtained. Erythropoietin dosages were monitored throughout the treatment period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* · Patients on Hemodialysis for at least 6 months\n\n * Patients on stable dose of epogen and iron supplementation for at least 1 month prior to B12 and MMA assay.\n\nExclusion Criteria:\n\n* · On B12 treatment\n\n * Hematological Cancer\n * Methotrexate use\n * Alcohol use greater then 2 drinks per day\n * Vegetarian Diet\n * Gastric Surgery\n * Inflammatory Bowel Disease\n * Pernicious Anemia\n * Recent transfusion'}, 'identificationModule': {'nctId': 'NCT01876732', 'briefTitle': 'Impact of Vitamin B12 Replacement on Epogen Dosing and Improvement of Quality of Life in Hemodialysis Patients', 'nctIdAliases': ['NCT01360983'], 'organization': {'class': 'OTHER', 'fullName': 'Northwell Health'}, 'officialTitle': 'Impact of Vitamin B12 Replacement on Epogen Dosing and Improvement of Quality of Life in Hemodialysis Patients', 'orgStudyIdInfo': {'id': '09-024'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Vitamin B12', 'description': 'Those with an MMA over 800nmol/L are given 1000mcg of intramuscular (IM) vitamin B12 weekly for the first month and then monthly for 3 consecutive months.', 'interventionNames': ['Drug: Vitamin B12']}], 'interventions': [{'name': 'Vitamin B12', 'type': 'DRUG', 'otherNames': ['Cyanocobalamin'], 'description': 'Consented subjects are screened for Vitamin B12 deficiency with measurements of serum vitamin B12 concentrations and plasma levels of MMA, drawn prior to the first hemodialysis (HD) session of the week. Those with an MMA over 800nmol/L are given 1000mcg of IM vitamin B12 weekly for the first month and then monthly for 3 consecutive months. Following therapy, serum B12, MMA levels, percent iron saturation, parathyroid levels and peripheral blood smear are to be repeated and compared to previous levels. Subjects also complete a Kidney Disease Quality of Life- 36 (KDQOL-36) prior to therapy and again post treatment.', 'armGroupLabels': ['Vitamin B12']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10305', 'city': 'Staten Island', 'state': 'New York', 'country': 'United States', 'facility': 'Island Rehab', 'geoPoint': {'lat': 40.56233, 'lon': -74.13986}}], 'overallOfficials': [{'name': 'Suzanne El-Sayegh, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'SIUH'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Northwell Health', 'class': 'OTHER'}, 'collaborators': [{'name': 'Staten Island University Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Nephrology Attending, Assoc. Chair of Medicine', 'investigatorFullName': 'Suzanne El-Sayegh', 'investigatorAffiliation': 'Northwell Health'}}}}