Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2026-04-14 @ 1:53 AM
Study NCT ID:
NCT01942694
Status:
COMPLETED
Last Update Posted:
2022-08-16
First Post:
2013-08-09
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Vitamin D and Type 2 Diabetes Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011236', 'term': 'Prediabetic State'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002762', 'term': 'Cholecalciferol'}], 'ancestors': [{'id': 'D002782', 'term': 'Cholestenes'}, {'id': 'D002776', 'term': 'Cholestanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013261', 'term': 'Sterols'}, {'id': 'D014807', 'term': 'Vitamin D'}, {'id': 'D012632', 'term': 'Secosteroids'}, {'id': 'D008563', 'term': 'Membrane Lipids'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'apittas@tuftsmedicalcenter.org', 'phone': '617-636-3232', 'title': 'Dr. Anastassios Pittas', 'organization': 'Division of Endocrinology, Diabetes, and Metabolism, Tufts Medical Center'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '2.5 years', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'One pill daily\n\nPlacebo: Administered as one soft-gel pill daily by mouth', 'otherNumAtRisk': 1212, 'deathsNumAtRisk': 1212, 'otherNumAffected': 26, 'seriousNumAtRisk': 1212, 'deathsNumAffected': 5, 'seriousNumAffected': 153}, {'id': 'EG001', 'title': 'Vitamin D (Cholecalciferol)', 'description': 'One vitamin D pill daily\n\nVitamin D (Cholecalciferol): Vitamin D (Cholecalciferol) 4000 IU, administered as 1 soft-gel pill daily by mouth.', 'otherNumAtRisk': 1211, 'deathsNumAtRisk': 1211, 'otherNumAffected': 31, 'seriousNumAtRisk': 1211, 'deathsNumAffected': 5, 'seriousNumAffected': 173}], 'otherEvents': [{'term': 'Hypercalcemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1212, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 1211, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fasting urine calcium: creatinine ratio >0.375', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1212, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1211, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Low estimated glomerular filtration rate', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1212, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1211, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1212, 'numEvents': 21, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 1211, 'numEvents': 25, 'numAffected': 24}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1212, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 1211, 'numAffected': 5}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1212, 'numAffected': 148}, {'groupId': 'EG001', 'numAtRisk': 1211, 'numAffected': 168}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Time to Development of Diabetes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1212', 'groupId': 'OG000'}, {'value': '1211', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'One pill daily\n\nPlacebo: Administered as one soft-gel pill daily by mouth'}, {'id': 'OG001', 'title': 'Vitamin D (Cholecalciferol)', 'description': 'One vitamin D pill daily\n\nVitamin D (Cholecalciferol): Vitamin D (Cholecalciferol) 4000 IU, administered as 1 soft-gel pill daily by mouth.'}], 'classes': [{'categories': [{'measurements': [{'value': '323', 'groupId': 'OG000'}, {'value': '293', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Approximately 48 months', 'description': 'New-onset diabetes was based on annual glycemic testing of fasting plasma glucose, glycated hemoglobin, and 2-hour post-load plasma glucose and semiannual testing of fasting plasma glucose and glycated hemoglobin. If two or three of the glycemic measures met the 2010 ADA thresholds for diabetes, the participant was considered to have met the diabetes outcome. When only the measure for fasting plasma glucose or glycated hemoglobin met the threshold, confirmatory testing was performed for the positive measure within 8 weeks. If only the measure for 2-hour post-load plasma glucose met the threshold, then a 75-g oral glucose tolerance test to reassess all three glycemic measures was repeated. If the repeat measure was positive or both fasting plasma glucose and glycated hemoglobin were positive (in the case of a repeat oral glucose tolerance test), than the participant was considered to have met the diabetes outcome.', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Variability of Response to Vitamin D Supplementation by Baseline Characteristic: 25OHD Concentration', 'timeFrame': 'Approximately 48 months', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Variability of Response to Vitamin D Supplementation by Baseline Characteristic: Race (as a Proxy for Skin Pigmentation)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1212', 'groupId': 'OG000'}, {'value': '1211', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'One pill daily\n\nPlacebo: Administered as one soft-gel pill daily by mouth'}, {'id': 'OG001', 'title': 'Vitamin D (Cholecalciferol)', 'description': 'One vitamin D pill daily\n\nVitamin D (Cholecalciferol): Vitamin D (Cholecalciferol) 4000 IU, administered as 1 soft-gel pill daily by mouth.'}], 'classes': [{'title': 'Race: White', 'categories': [{'measurements': [{'value': '806', 'groupId': 'OG000'}, {'value': '810', 'groupId': 'OG001'}]}]}, {'title': 'Race: Black', 'categories': [{'measurements': [{'value': '315', 'groupId': 'OG000'}, {'value': '301', 'groupId': 'OG001'}]}]}, {'title': 'Race: Other', 'categories': [{'measurements': [{'value': '91', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}]}, {'title': 'Ethnic Group: Hispanic', 'categories': [{'measurements': [{'value': '105', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG001'}]}]}, {'title': 'Ethnic Group: Non-Hispanic', 'categories': [{'measurements': [{'value': '1107', 'groupId': 'OG000'}, {'value': '1091', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Approximately 48 months', 'description': 'Race and ethnic group were reporting by the participant. The category "other" includes American Indian or Alaska Native; Native Hawaiian or other Pacific Islander; and other race. Ethnic group includes any race.', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Variability of Response to Vitamin D Supplementation by Baseline Characteristic: Pre-diabetes Criteria (Two vs. Three Criteria)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1212', 'groupId': 'OG000'}, {'value': '1211', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'One pill daily\n\nPlacebo: Administered as one soft-gel pill daily by mouth'}, {'id': 'OG001', 'title': 'Vitamin D (Cholecalciferol)', 'description': 'One vitamin D pill daily\n\nVitamin D (Cholecalciferol): Vitamin D (Cholecalciferol) 4000 IU, administered as 1 soft-gel pill daily by mouth.'}], 'classes': [{'title': 'Met all three criteria', 'categories': [{'measurements': [{'value': '429', 'groupId': 'OG000'}, {'value': '427', 'groupId': 'OG001'}]}]}, {'title': 'Met two criteria', 'categories': [{'measurements': [{'value': '783', 'groupId': 'OG000'}, {'value': '784', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Approximately 48 months', 'description': 'Participants met at least two of three glycemic criteria for prediabetes: fasting plasma glucose level, 100 to 125 mg per deciliter (5.6 to 6.9 mmol per liter); plasma glucose level 2 hours after a 75-g oral glucose load, 140 to 199 mg per deciliter (7.8 to 11.0 mmol per liter) (impaired glucose tolerance); and glycated hemoglobin level, 5.7 to 6.4% (39 to 47 mmol per mole).', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Variability of Response to Vitamin D Supplementation by Baseline Characteristic: BMI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1212', 'groupId': 'OG000'}, {'value': '1211', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'One pill daily\n\nPlacebo: Administered as one soft-gel pill daily by mouth'}, {'id': 'OG001', 'title': 'Vitamin D (Cholecalciferol)', 'description': 'One vitamin D pill daily\n\nVitamin D (Cholecalciferol): Vitamin D (Cholecalciferol) 4000 IU, administered as 1 soft-gel pill daily by mouth.'}], 'classes': [{'title': '<30', 'categories': [{'measurements': [{'value': '429', 'groupId': 'OG000'}, {'value': '435', 'groupId': 'OG001'}]}]}, {'title': '≥30', 'categories': [{'measurements': [{'value': '783', 'groupId': 'OG000'}, {'value': '776', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Approximately 48 months', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Variability of Response to Vitamin D Supplementation by Baseline Characteristic: Waist Circumference', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1212', 'groupId': 'OG000'}, {'value': '1211', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'One pill daily\n\nPlacebo: Administered as one soft-gel pill daily by mouth'}, {'id': 'OG001', 'title': 'Vitamin D (Cholecalciferol)', 'description': 'One vitamin D pill daily\n\nVitamin D (Cholecalciferol): Vitamin D (Cholecalciferol) 4000 IU, administered as 1 soft-gel pill daily by mouth.'}], 'classes': [{'title': '<Median of 104.2 cm', 'categories': [{'measurements': [{'value': '585', 'groupId': 'OG000'}, {'value': '620', 'groupId': 'OG001'}]}]}, {'title': '≥Median of 104.2 cm', 'categories': [{'measurements': [{'value': '627', 'groupId': 'OG000'}, {'value': '591', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Approximately 48 months', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Variability of Response to Vitamin D Supplementation by Baseline Characteristic: Age', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1212', 'groupId': 'OG000'}, {'value': '1211', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'One pill daily\n\nPlacebo: Administered as one soft-gel pill daily by mouth'}, {'id': 'OG001', 'title': 'Vitamin D (Cholecalciferol)', 'description': 'One vitamin D pill daily\n\nVitamin D (Cholecalciferol): Vitamin D (Cholecalciferol) 4000 IU, administered as 1 soft-gel pill daily by mouth.'}], 'classes': [{'title': '25-44', 'categories': [{'measurements': [{'value': '103', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}]}]}, {'title': '45-59', 'categories': [{'measurements': [{'value': '439', 'groupId': 'OG000'}, {'value': '468', 'groupId': 'OG001'}]}]}, {'title': '≥ 60', 'categories': [{'measurements': [{'value': '670', 'groupId': 'OG000'}, {'value': '637', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Approximately 48 months', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Variability of Response to Vitamin D Supplementation by Baseline Characteristic: Geographic Location (as a Proxy for Sun Exposure)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1212', 'groupId': 'OG000'}, {'value': '1211', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'One pill daily\n\nPlacebo: Administered as one soft-gel pill daily by mouth'}, {'id': 'OG001', 'title': 'Vitamin D (Cholecalciferol)', 'description': 'One vitamin D pill daily\n\nVitamin D (Cholecalciferol): Vitamin D (Cholecalciferol) 4000 IU, administered as 1 soft-gel pill daily by mouth.'}], 'classes': [{'title': 'At or above 37° north latitude', 'categories': [{'measurements': [{'value': '898', 'groupId': 'OG000'}, {'value': '892', 'groupId': 'OG001'}]}]}, {'title': 'Below 37° north latitude', 'categories': [{'measurements': [{'value': '314', 'groupId': 'OG000'}, {'value': '319', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Approximately 48 months', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Variability of Response to Vitamin D Supplementation by Baseline Characteristic: Calcium Intake From Supplements', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1212', 'groupId': 'OG000'}, {'value': '1211', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'One pill daily\n\nPlacebo: Administered as one soft-gel pill daily by mouth'}, {'id': 'OG001', 'title': 'Vitamin D (Cholecalciferol)', 'description': 'One vitamin D pill daily\n\nVitamin D (Cholecalciferol): Vitamin D (Cholecalciferol) 4000 IU, administered as 1 soft-gel pill daily by mouth.'}], 'classes': [{'title': 'No intake', 'categories': [{'measurements': [{'value': '793', 'groupId': 'OG000'}, {'value': '826', 'groupId': 'OG001'}]}]}, {'title': 'Any intake', 'categories': [{'measurements': [{'value': '419', 'groupId': 'OG000'}, {'value': '385', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Approximately 48 months', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Blood Plasma 25OHD Concentration.', 'timeFrame': 'Approximately 48 months', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Adverse Events.', 'timeFrame': 'Approximately 48 months', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Change in Blood Pressure as a Continuous Variable.', 'timeFrame': 'Approximately 48 months', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Discontinue Study Pills.', 'timeFrame': 'Approximately 48 months', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Change in FPG as a Continuous Variable.', 'timeFrame': 'Every 12 months for approximately 48 months', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Change in 2hPG as a Continuous Variable.', 'timeFrame': 'Every 12 months for approximately 48 months.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Change in HbA1c as a Continuous Variable.', 'timeFrame': 'Every 6 months for approximately 48 months', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Measurement of Insulin Resistance (Derived From the OGTT).', 'timeFrame': 'Every 12 months for approximately 48 months', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Measurement of Beta Cell Secretion (Derived From the OGTT)', 'timeFrame': 'Every 12 months for approximately 48 months', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Identification of Characteristics Associated With the Variability in Achieved 25OHD Concentration.', 'timeFrame': 'Every 12 months for approximately 48 months', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Variability of Response to Vitamin D Supplementation by Baseline Characteristic: Sex', 'timeFrame': 'Approximately 48 months.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Variability of Response to Vitamin D Supplementation by Baseline Characteristic: Ethnicity', 'timeFrame': 'Approximately 48 months.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Variability of Response to Vitamin D Supplementation by Baseline Characteristic: 2 Hour Plasma Glucose', 'timeFrame': 'Approximately 48 months', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Time to Development of Cancer.', 'timeFrame': 'Approximately 48 months.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Time to Development of Cardiovascular Event.', 'timeFrame': 'Approximately 48 months.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Incidence of Cancer in a Pre-diabetes Population Defined by the Modern American Diabetes Association Criteria.', 'timeFrame': 'Approximately 48 months.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Incidence of Cardiovascular Disease in a Pre-diabetes Population Defined by the Modern American Diabetes Association Criteria.', 'timeFrame': 'Approximately 48 months.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Quality of Life and Mood Scores in Pre-diabetes Population Using a Validated Instrument (PROMIS-29 Profile v2.0 and a General Question on Perception of Overall Health From the PROMIS Scale 1.2).', 'timeFrame': 'One time assessment at the month 24 visit.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'One pill daily\n\nPlacebo: Administered as one soft-gel pill daily by mouth'}, {'id': 'FG001', 'title': 'Vitamin D (Cholecalciferol)', 'description': 'One vitamin D pill daily\n\nVitamin D (Cholecalciferol): Vitamin D (Cholecalciferol) 4000 IU, administered as 1 soft-gel pill daily by mouth.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1212'}, {'groupId': 'FG001', 'numSubjects': '1211'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1211'}, {'groupId': 'FG001', 'numSubjects': '1211'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1212', 'groupId': 'BG000'}, {'value': '1211', 'groupId': 'BG001'}, {'value': '2423', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'One pill daily\n\nPlacebo: Administered as one soft-gel pill daily by mouth'}, {'id': 'BG001', 'title': 'Vitamin D (Cholecalciferol)', 'description': 'One vitamin D pill daily\n\nVitamin D (Cholecalciferol): Vitamin D (Cholecalciferol) 4000 IU, administered as 1 soft-gel pill daily by mouth.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '60.4', 'spread': '10.0', 'groupId': 'BG000'}, {'value': '59.6', 'spread': '9.9', 'groupId': 'BG001'}, {'value': '60.0', 'spread': '9.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '545', 'groupId': 'BG000'}, {'value': '541', 'groupId': 'BG001'}, {'value': '1086', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '667', 'groupId': 'BG000'}, {'value': '670', 'groupId': 'BG001'}, {'value': '1337', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '105', 'groupId': 'BG000'}, {'value': '120', 'groupId': 'BG001'}, {'value': '225', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '1107', 'groupId': 'BG000'}, {'value': '1091', 'groupId': 'BG001'}, {'value': '2198', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '64', 'groupId': 'BG000'}, {'value': '66', 'groupId': 'BG001'}, {'value': '130', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '315', 'groupId': 'BG000'}, {'value': '301', 'groupId': 'BG001'}, {'value': '616', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '806', 'groupId': 'BG000'}, {'value': '810', 'groupId': 'BG001'}, {'value': '1616', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '1212', 'groupId': 'BG000'}, {'value': '1211', 'groupId': 'BG001'}, {'value': '2423', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Fasting plasma glucose (mg/dl)', 'classes': [{'categories': [{'measurements': [{'value': '107.8', 'spread': '7.4', 'groupId': 'BG000'}, {'value': '108.0', 'spread': '7.4', 'groupId': 'BG001'}, {'value': '107.9', 'spread': '7.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dl', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': '2-Hr post-load plasma glucose (mg/dl)', 'classes': [{'categories': [{'measurements': [{'value': '137.6', 'spread': '34.3', 'groupId': 'BG000'}, {'value': '136.9', 'spread': '34.3', 'groupId': 'BG001'}, {'value': '137.2', 'spread': '34.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dl', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Glycated hemoglobin (%)', 'classes': [{'categories': [{'measurements': [{'value': '5.9', 'spread': '0.2', 'groupId': 'BG000'}, {'value': '5.9', 'spread': '0.2', 'groupId': 'BG001'}, {'value': '5.9', 'spread': '0.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': '%', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Serum 25-hydroxyvitamin D (ng/ml)', 'classes': [{'categories': [{'measurements': [{'value': '28.2', 'spread': '10.1', 'groupId': 'BG000'}, {'value': '27.7', 'spread': '10.2', 'groupId': 'BG001'}, {'value': '28.0', 'spread': '10.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'ng/ml', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-07-11', 'size': 1995756, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-02-03T12:37', 'hasProtocol': True}, {'date': '2018-03-20', 'size': 995996, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2020-02-03T15:53', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2423}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2018-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-07-22', 'studyFirstSubmitDate': '2013-08-09', 'resultsFirstSubmitDate': '2020-08-10', 'studyFirstSubmitQcDate': '2013-09-10', 'lastUpdatePostDateStruct': {'date': '2022-08-16', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-08-20', 'studyFirstPostDateStruct': {'date': '2013-09-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-09-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Variability of Response to Vitamin D Supplementation by Baseline Characteristic: Sex', 'timeFrame': 'Approximately 48 months.'}, {'measure': 'Variability of Response to Vitamin D Supplementation by Baseline Characteristic: Ethnicity', 'timeFrame': 'Approximately 48 months.'}, {'measure': 'Variability of Response to Vitamin D Supplementation by Baseline Characteristic: 2 Hour Plasma Glucose', 'timeFrame': 'Approximately 48 months'}, {'measure': 'Time to Development of Cancer.', 'timeFrame': 'Approximately 48 months.'}, {'measure': 'Time to Development of Cardiovascular Event.', 'timeFrame': 'Approximately 48 months.'}, {'measure': 'Incidence of Cancer in a Pre-diabetes Population Defined by the Modern American Diabetes Association Criteria.', 'timeFrame': 'Approximately 48 months.'}, {'measure': 'Incidence of Cardiovascular Disease in a Pre-diabetes Population Defined by the Modern American Diabetes Association Criteria.', 'timeFrame': 'Approximately 48 months.'}, {'measure': 'Quality of Life and Mood Scores in Pre-diabetes Population Using a Validated Instrument (PROMIS-29 Profile v2.0 and a General Question on Perception of Overall Health From the PROMIS Scale 1.2).', 'timeFrame': 'One time assessment at the month 24 visit.'}], 'primaryOutcomes': [{'measure': 'Time to Development of Diabetes', 'timeFrame': 'Approximately 48 months', 'description': 'New-onset diabetes was based on annual glycemic testing of fasting plasma glucose, glycated hemoglobin, and 2-hour post-load plasma glucose and semiannual testing of fasting plasma glucose and glycated hemoglobin. If two or three of the glycemic measures met the 2010 ADA thresholds for diabetes, the participant was considered to have met the diabetes outcome. When only the measure for fasting plasma glucose or glycated hemoglobin met the threshold, confirmatory testing was performed for the positive measure within 8 weeks. If only the measure for 2-hour post-load plasma glucose met the threshold, then a 75-g oral glucose tolerance test to reassess all three glycemic measures was repeated. If the repeat measure was positive or both fasting plasma glucose and glycated hemoglobin were positive (in the case of a repeat oral glucose tolerance test), than the participant was considered to have met the diabetes outcome.'}], 'secondaryOutcomes': [{'measure': 'Variability of Response to Vitamin D Supplementation by Baseline Characteristic: 25OHD Concentration', 'timeFrame': 'Approximately 48 months'}, {'measure': 'Variability of Response to Vitamin D Supplementation by Baseline Characteristic: Race (as a Proxy for Skin Pigmentation)', 'timeFrame': 'Approximately 48 months', 'description': 'Race and ethnic group were reporting by the participant. The category "other" includes American Indian or Alaska Native; Native Hawaiian or other Pacific Islander; and other race. Ethnic group includes any race.'}, {'measure': 'Variability of Response to Vitamin D Supplementation by Baseline Characteristic: Pre-diabetes Criteria (Two vs. Three Criteria)', 'timeFrame': 'Approximately 48 months', 'description': 'Participants met at least two of three glycemic criteria for prediabetes: fasting plasma glucose level, 100 to 125 mg per deciliter (5.6 to 6.9 mmol per liter); plasma glucose level 2 hours after a 75-g oral glucose load, 140 to 199 mg per deciliter (7.8 to 11.0 mmol per liter) (impaired glucose tolerance); and glycated hemoglobin level, 5.7 to 6.4% (39 to 47 mmol per mole).'}, {'measure': 'Variability of Response to Vitamin D Supplementation by Baseline Characteristic: BMI', 'timeFrame': 'Approximately 48 months'}, {'measure': 'Variability of Response to Vitamin D Supplementation by Baseline Characteristic: Waist Circumference', 'timeFrame': 'Approximately 48 months'}, {'measure': 'Variability of Response to Vitamin D Supplementation by Baseline Characteristic: Age', 'timeFrame': 'Approximately 48 months'}, {'measure': 'Variability of Response to Vitamin D Supplementation by Baseline Characteristic: Geographic Location (as a Proxy for Sun Exposure)', 'timeFrame': 'Approximately 48 months'}, {'measure': 'Variability of Response to Vitamin D Supplementation by Baseline Characteristic: Calcium Intake From Supplements', 'timeFrame': 'Approximately 48 months'}, {'measure': 'Blood Plasma 25OHD Concentration.', 'timeFrame': 'Approximately 48 months'}, {'measure': 'Number of Participants With Adverse Events.', 'timeFrame': 'Approximately 48 months'}, {'measure': 'Change in Blood Pressure as a Continuous Variable.', 'timeFrame': 'Approximately 48 months'}, {'measure': 'Number of Participants Who Discontinue Study Pills.', 'timeFrame': 'Approximately 48 months'}, {'measure': 'Change in FPG as a Continuous Variable.', 'timeFrame': 'Every 12 months for approximately 48 months'}, {'measure': 'Change in 2hPG as a Continuous Variable.', 'timeFrame': 'Every 12 months for approximately 48 months.'}, {'measure': 'Change in HbA1c as a Continuous Variable.', 'timeFrame': 'Every 6 months for approximately 48 months'}, {'measure': 'Measurement of Insulin Resistance (Derived From the OGTT).', 'timeFrame': 'Every 12 months for approximately 48 months'}, {'measure': 'Measurement of Beta Cell Secretion (Derived From the OGTT)', 'timeFrame': 'Every 12 months for approximately 48 months'}, {'measure': 'Identification of Characteristics Associated With the Variability in Achieved 25OHD Concentration.', 'timeFrame': 'Every 12 months for approximately 48 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Prediabetes', 'Vitamin D'], 'conditions': ['Prediabetes', 'Type 2 Diabetes']}, 'referencesModule': {'references': [{'pmid': '37104979', 'type': 'DERIVED', 'citation': 'Corbin KD, Pittas AG, Desouza C, Grdinovac KK, Herzig KH, Kashyap SR, Kim SH, Nelson J, Rasouli N, Vickery EM, Knowler WC, Pratley RE. Indices of hepatic steatosis and fibrosis in prediabetes and association with diabetes development in the vitamin D and type 2 diabetes study. J Diabetes Complications. 2023 Jun;37(6):108475. doi: 10.1016/j.jdiacomp.2023.108475. Epub 2023 Apr 12.'}, {'pmid': '37001590', 'type': 'DERIVED', 'citation': 'Chatterjee R, Davenport CA, Vickery EM, Johnson KC, Kashyap SR, LeBlanc ES, Nelson J, Dagogo-Jack S, Pittas AG, Hughes BD; D2d Research Group. Effect of intratrial mean 25(OH)D concentration on diabetes risk, by race and weight: an ancillary analysis in the D2d study. Am J Clin Nutr. 2023 Jul;118(1):59-67. doi: 10.1016/j.ajcnut.2023.03.021. Epub 2023 Mar 29.'}, {'pmid': '35753926', 'type': 'DERIVED', 'citation': 'Desouza C, Chatterjee R, Vickery EM, Nelson J, Johnson KC, Kashyap SR, Lewis MR, Margolis K, Pratley R, Rasouli N, Sheehan PR, Pittas AG; D2d Research Group. Electronic address: d2d@tuftsmedicalcenter.org. The effect of vitamin D supplementation on cardiovascular risk in patients with prediabetes: A secondary analysis of the D2d study. J Diabetes Complications. 2022 Aug;36(8):108230. doi: 10.1016/j.jdiacomp.2022.108230. Epub 2022 Jun 12.'}, {'pmid': '35140313', 'type': 'DERIVED', 'citation': 'Johnson KC, Pittas AG, Margolis KL, Peters AL, Phillips LS, Vickery EM, Nelson J, Sheehan PR, Reboussin D, Malozowski S, Chatterjee R; D2d research group. Safety and tolerability of high-dose daily vitamin D3 supplementation in the vitamin D and type 2 diabetes (D2d) study-a randomized trial in persons with prediabetes. Eur J Clin Nutr. 2022 Aug;76(8):1117-1124. doi: 10.1038/s41430-022-01068-8. Epub 2022 Feb 9.'}, {'pmid': '33693713', 'type': 'DERIVED', 'citation': 'Chatterjee R, Fuss P, Vickery EM, LeBlanc ES, Sheehan PR, Lewis MR, Dolor RJ, Johnson KC, Kashyap SR, Nelson J, Pittas AG; D2d Research Group. Vitamin D Supplementation for Prevention of Cancer: The D2d Cancer Outcomes (D2dCA) Ancillary Study. J Clin Endocrinol Metab. 2021 Aug 18;106(9):2767-2778. doi: 10.1210/clinem/dgab153.'}, {'pmid': '31965161', 'type': 'DERIVED', 'citation': 'Hsia DS, Rasouli N, Pittas AG, Lary CW, Peters A, Lewis MR, Kashyap SR, Johnson KC, LeBlanc ES, Phillips LS, Hempe JM, Desouza CV; D2d Research Group. Implications of the Hemoglobin Glycation Index on the Diagnosis of Prediabetes and Diabetes. J Clin Endocrinol Metab. 2020 Mar 1;105(3):e130-8. doi: 10.1210/clinem/dgaa029.'}, {'pmid': '31173679', 'type': 'DERIVED', 'citation': "Pittas AG, Dawson-Hughes B, Sheehan P, Ware JH, Knowler WC, Aroda VR, Brodsky I, Ceglia L, Chadha C, Chatterjee R, Desouza C, Dolor R, Foreyt J, Fuss P, Ghazi A, Hsia DS, Johnson KC, Kashyap SR, Kim S, LeBlanc ES, Lewis MR, Liao E, Neff LM, Nelson J, O'Neil P, Park J, Peters A, Phillips LS, Pratley R, Raskin P, Rasouli N, Robbins D, Rosen C, Vickery EM, Staten M; D2d Research Group. Vitamin D Supplementation and Prevention of Type 2 Diabetes. N Engl J Med. 2019 Aug 8;381(6):520-530. doi: 10.1056/NEJMoa1900906. Epub 2019 Jun 7."}, {'pmid': '31007049', 'type': 'DERIVED', 'citation': 'Aroda VR, Sheehan PR, Vickery EM, Staten MA, LeBlanc ES, Phillips LS, Brodsky IG, Chadha C, Chatterjee R, Ouellette MG, Desouza C, Pittas AG; D2d Research Group. Establishing an electronic health record-supported approach for outreach to and recruitment of persons at high risk of type 2 diabetes in clinical trials: The vitamin D and type 2 diabetes (D2d) study experience. Clin Trials. 2019 Jun;16(3):306-315. doi: 10.1177/1740774519839062. Epub 2019 Apr 22.'}, {'pmid': '29941495', 'type': 'DERIVED', 'citation': "LeBlanc ES, Pratley RE, Dawson-Hughes B, Staten MA, Sheehan PR, Lewis MR, Peters A, Kim SH, Chatterjee R, Aroda VR, Chadha C, Neff LM, Brodsky IG, Rosen C, Desouza CV, Foreyt JP, Hsia DS, Johnson KC, Raskin P, Kashyap SR, O'Neil P, Phillips LS, Rasouli N, Liao EP, Robbins DC, Pittas AG; D2d Research Group. Baseline Characteristics of the Vitamin D and Type 2 Diabetes (D2d) Study: A Contemporary Prediabetes Cohort That Will Inform Diabetes Prevention Efforts. Diabetes Care. 2018 Aug;41(8):1590-1599. doi: 10.2337/dc18-0240. Epub 2018 Jun 25."}, {'pmid': '27899488', 'type': 'DERIVED', 'citation': 'Lewis MR, Macauley RC, Sheehan PR, Staten MA, Phillips LS, Rasouli N, Pittas AG; D2d Research Group. Management of Hemoglobin Variants Detected Incidentally in HbA1c Testing: A Common Problem Currently Lacking a Standard Approach. Diabetes Care. 2017 Feb;40(2):e8-e9. doi: 10.2337/dc16-1667. Epub 2016 Nov 29. No abstract available.'}, {'pmid': '25205139', 'type': 'DERIVED', 'citation': 'Pittas AG, Dawson-Hughes B, Sheehan PR, Rosen CJ, Ware JH, Knowler WC, Staten MA; D2d Research Group. Rationale and design of the Vitamin D and Type 2 Diabetes (D2d) study: a diabetes prevention trial. Diabetes Care. 2014 Dec;37(12):3227-34. doi: 10.2337/dc14-1005. Epub 2014 Sep 9.'}]}, 'descriptionModule': {'briefSummary': 'The goal of the Vitamin D and type 2 diabetes (D2d) study is to determine if vitamin D supplementation works to delay the onset of type 2 diabetes in people at risk for the disease and to gain a better understand how vitamin D affects glucose (sugar) metabolism.', 'detailedDescription': 'The goal of the Vitamin D and type 2 diabetes (D2d) study is to determine if vitamin D supplementation works to delay the onset of type 2 diabetes in people at risk for the disease and to gain a better understand how vitamin D affects glucose (sugar) metabolism. Researchers at US sites will enroll people with pre-diabetes (people who have higher than normal blood glucose level but not high enough to meet the diagnosis of diabetes). The study will enroll participants over approximately 2 years and participants will be followed for approximately 3 years. Participants will receive either Vitamin D or a placebo by chance. Participants will take 1 pill a day for the duration of the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Pre-diabetes ("at increased risk for diabetes") defined by meeting 2-out-of-3 of the following glycemic criteria at the baseline visit:\n\n 1. Fasting plasma glucose (FPG) 100-125 mg/dL\n 2. 2-hour plasma glucose (2hPG) 140-199 mg/dL\n 3. Hemoglobin A1c (HbA1c) 5.7-6.4%\n2. Age ≥ 30 years .(≥25 years for people of the following races: American-Indian, Alaska Native, Native Hawaiian or Other Pacific Islander).\n3. Body Mass Index ≥ 24.0 (22.5 for Asians) and ≤ 42.0 kg/m2\n4. Provision of signed and dated written informed consent prior to any study procedures.\n\nMajor Exclusion Criteria:\n\n1. Diabetes based on either of the following criteria:\n\n 1. History (past 1 year) of hypoglycemic pharmacotherapy (oral or injectable medication approved by the FDA for type 2 diabetes), used for any condition (e.g. pre-diabetes, diabetes, polycystic ovarian syndrome.\n 2. Meeting the diagnosis criteria for diabetes\n2. History (past 3 years) of hyperparathyroidism, nephrolithiasis or hypercalcemia.\n3. Pregnancy (past 1 year by report or positive pregnancy test at screening), intent to become pregnant in the next 4 years or unprotected intercourse. History of gestational diabetes is not an exclusion criterion.\n4. Currently breastfeeding.'}, 'identificationModule': {'nctId': 'NCT01942694', 'acronym': 'D2d', 'briefTitle': 'Vitamin D and Type 2 Diabetes Study', 'nctIdAliases': ['NCT02015052', 'NCT02239471'], 'organization': {'class': 'OTHER', 'fullName': 'Tufts Medical Center'}, 'officialTitle': 'Vitamin D and Type 2 Diabetes Study', 'orgStudyIdInfo': {'id': 'U01DK098245', 'link': 'https://reporter.nih.gov/quickSearch/U01DK098245', 'type': 'NIH'}, 'secondaryIdInfos': [{'id': 'U01DK098245', 'link': 'https://reporter.nih.gov/quickSearch/U01DK098245', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'One pill daily', 'interventionNames': ['Other: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Vitamin D (Cholecalciferol)', 'description': 'One vitamin D pill daily', 'interventionNames': ['Dietary Supplement: Vitamin D (Cholecalciferol)']}], 'interventions': [{'name': 'Vitamin D (Cholecalciferol)', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Vitamin D (Cholecalciferol) 4000 IU, administered as 1 soft-gel pill daily by mouth.', 'armGroupLabels': ['Vitamin D (Cholecalciferol)']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Administered as one soft-gel pill daily by mouth', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85016', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Southwest American Indian Center', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '90022', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'University of Southern California', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '94304', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado, Denver', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '32803', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Orlando VA Medical Center', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '32804', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida Hospital Translational Research Institute', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '30033', 'city': 'Decatur', 'state': 'Georgia', 'country': 'United States', 'facility': 'Atlanta VA Medical Center', 'geoPoint': {'lat': 33.77483, 'lon': -84.29631}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern University', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '66205', 'city': 'Kansas City', 'state': 'Kansas', 'country': 'United States', 'facility': 'University of Kansas Medical Center', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}, {'zip': '70808', 'city': 'Baton Rouge', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Pennington Biomedical Research Center', 'geoPoint': {'lat': 30.44332, 'lon': -91.18747}}, {'zip': '70112', 'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Tulane University Health Sciences', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'zip': '04074', 'city': 'Scarborough', 'state': 'Maine', 'country': 'United States', 'facility': 'Maine Medical Center', 'geoPoint': {'lat': 43.57814, 'lon': -70.32172}}, {'zip': '20782', 'city': 'Hyattsville', 'state': 'Maryland', 'country': 'United States', 'facility': 'MedStar Community Clinical Research Center', 'geoPoint': {'lat': 38.95594, 'lon': -76.94553}}, {'zip': '02111', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Tufts Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '55454', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Health Partners Riverside Clinic', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '68105', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Omaha VA Medical Center', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '68198', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'University of Nebraska Medical Center', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '10003', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Beth Israel Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '27704', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '97227', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Kaiser Permanente Center for Health Research', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '29425', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Medical University of South Carolina', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '38105', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': 'University of Tennessee Health Science Center', 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}, {'zip': '75390', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas Southwestern Medical Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Baylor College of Medicine', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Anastassios Pittas, MD, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tufts Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tufts Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}, {'name': 'Office of Dietary Supplements (ODS)', 'class': 'NIH'}, {'name': 'American Diabetes Association', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}