Ignite Creation Date:
2025-12-25 @ 5:09 AM
Ignite Modification Date:
2025-12-26 @ 4:13 AM
Study NCT ID:
NCT03046927
Status:
COMPLETED
Last Update Posted:
2024-07-10
First Post:
2017-02-01
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Vitamin D and Residual Beta-Cell Function in Type 1 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2022-05-06', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}], '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'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004872', 'term': 'Ergocalciferols'}, {'id': 'D014807', 'term': 'Vitamin D'}], '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': 'D012632', 'term': 'Secosteroids'}, {'id': 'D008563', 'term': 'Membrane Lipids'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'bnwosu1@northwell.edu', 'phone': '5083406936', 'title': 'Benjamin U. Nwosu, MD', 'organization': 'University of Mass Medical'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '12 months', 'eventGroups': [{'id': 'EG000', 'title': 'Ergocalciferol', 'description': 'Oral administration of 50,000 IU of ergocalciferol one capsule per week for 2 months; and then once every 2 weeks for 10 months in 20 subjects of 10-21yr with newly diagnosed T1D\n\nErgocalciferol: Each subject on the experimental arm will receive one capsule of ergocalciferol per week for 2 months; and then once every 2 weeks for 10 months', 'otherNumAtRisk': 18, 'deathsNumAtRisk': 18, 'otherNumAffected': 1, 'seriousNumAtRisk': 18, 'deathsNumAffected': 0, 'seriousNumAffected': 7}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Oral administration of placebo one capsule per week for 2 months; and then once every 2 weeks for 10 months in 20 subjects of 10-21yr with newly diagnosed T1D\n\nPlacebo: Each subject on the placebo arm will receive one capsule of placebo per week for 2 months; and then once every 2 weeks for 10 months', 'otherNumAtRisk': 18, 'deathsNumAtRisk': 18, 'otherNumAffected': 5, 'seriousNumAtRisk': 18, 'deathsNumAffected': 0, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'upper respiratory infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'mild hair loss', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Diabetic ketoacidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hyperglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'mild hypoglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'moderate hypoglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Residual Beta-cell Function (RBCF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ergocalciferol', 'description': 'Oral administration of 50,000 IU of ergocalciferol one capsule per week for 2 months; and then once every 2 weeks for 10 months in 20 subjects of 10-21yr with newly diagnosed T1D\n\nErgocalciferol: Each subject on the experimental arm will receive one capsule of ergocalciferol per week for 2 months; and then once every 2 weeks for 10 months'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Oral administration of placebo one capsule per week for 2 months; and then once every 2 weeks for 10 months in 20 subjects of 10-21yr with newly diagnosed T1D\n\nPlacebo: Each subject on the placebo arm will receive one capsule of placebo per week for 2 months; and then once every 2 weeks for 10 months'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '1.78', 'spread': '0.28', 'groupId': 'OG000'}, {'value': '2.27', 'spread': '0.31', 'groupId': 'OG001'}]}]}, {'title': 'Mo 3', 'categories': [{'measurements': [{'value': '1.56', 'spread': '0.25', 'groupId': 'OG000'}, {'value': '1.76', 'spread': '0.21', 'groupId': 'OG001'}]}]}, {'title': 'Mo 6', 'categories': [{'measurements': [{'value': '1.40', 'spread': '0.26', 'groupId': 'OG000'}, {'value': '1.53', 'spread': '0.25', 'groupId': 'OG001'}]}]}, {'title': 'Mo 9', 'categories': [{'measurements': [{'value': '1.25', 'spread': '0.24', 'groupId': 'OG000'}, {'value': '1.36', 'spread': '0.31', 'groupId': 'OG001'}]}]}, {'title': 'Mo 12', 'categories': [{'measurements': [{'value': '1.05', 'spread': '0.22', 'groupId': 'OG000'}, {'value': '1.15', 'spread': '0.29', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.08', 'estimateComment': 'Trend analysis was performed using generalized linear model with GEE for repeated measures.', 'statisticalMethod': 'generalized linear model with dependent', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'p values were obtained using generalized linear model with GEE for repeated measures.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to 12 months at 3 months interval', 'description': 'Investigation of the effect of vitamin D on residual beta cell function (RBCF) in the first 12 months after the diagnosis of T1D by using stimulated C-peptide levels to quantify RBCF.', 'unitOfMeasure': 'ng/ml', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'individuals aged 10-21 years with newly diagnosed T1D in a 12-month RCT of ergocalciferol vs placebo to determine the effect of vitamin D on RBCF and PR in youth with newly diagnosed T1D.'}, {'type': 'SECONDARY', 'title': 'Change in Percent of HbA1c From Baseline Over Time During Partial Clinical Remission (PCR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ergocalciferol', 'description': 'Oral administration of 50,000 IU of ergocalciferol one capsule per week for 2 months; and then once every 2 weeks for 10 months in 20 subjects of 10-21yr with newly diagnosed T1D\n\nErgocalciferol: Each subject on the experimental arm will receive one capsule of ergocalciferol per week for 2 months; and then once every 2 weeks for 10 months'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Oral administration of placebo one capsule per week for 2 months; and then once every 2 weeks for 10 months in 20 subjects of 10-21yr with newly diagnosed T1D\n\nPlacebo: Each subject on the placebo arm will receive one capsule of placebo per week for 2 months; and then once every 2 weeks for 10 months'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '7.62', 'spread': '0.32', 'groupId': 'OG000'}, {'value': '7.47', 'spread': '0.39', 'groupId': 'OG001'}]}]}, {'title': 'Mo 3', 'categories': [{'measurements': [{'value': '7.25', 'spread': '0.37', 'groupId': 'OG000'}, {'value': '6.67', 'spread': '0.28', 'groupId': 'OG001'}]}]}, {'title': 'Mo 6', 'categories': [{'measurements': [{'value': '7.28', 'spread': '0.27', 'groupId': 'OG000'}, {'value': '7.15', 'spread': '0.34', 'groupId': 'OG001'}]}]}, {'title': 'Mo 9', 'categories': [{'measurements': [{'value': '7.48', 'spread': '0.35', 'groupId': 'OG000'}, {'value': '7.61', 'spread': '0.32', 'groupId': 'OG001'}]}]}, {'title': 'Mo 12', 'categories': [{'measurements': [{'value': '7.65', 'spread': '0.57', 'groupId': 'OG000'}, {'value': '8.03', 'spread': '0.41', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.01', 'groupIds': ['OG000', 'OG001'], 'paramType': 'trend analysis', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.04', 'pValueComment': 'The threshold for statistical significance was p=0.05', 'estimateComment': 'Trend analysis was performed using generalized linear model with GEE for repeated measures.', 'statisticalMethod': 'generalized linear model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'p values were obtained using generalized linear model with GEE for repeated measures.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to 12 months', 'description': 'Effect of vitamin D supplementation on glycemic control during the partial clinical remission phase as shown by the change in percent HbA1c from baseline across longitudinal measurements at 0, 3, 6, 9, and 12 months.', 'unitOfMeasure': 'percent of HbA1C', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Glucagon-like Peptide-1 (GLP-1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ergocalciferol', 'description': 'Oral administration of 50,000 IU of ergocalciferol one capsule per week for 2 months; and then once every 2 weeks for 10 months in 20 subjects of 10-21yr with newly diagnosed T1D\n\nErgocalciferol: Each subject on the experimental arm will receive one capsule of ergocalciferol per week for 2 months; and then once every 2 weeks for 10 months'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Oral administration of placebo one capsule per week for 2 months; and then once every 2 weeks for 10 months in 20 subjects of 10-21yr with newly diagnosed T1D\n\nPlacebo: Each subject on the placebo arm will receive one capsule of placebo per week for 2 months; and then once every 2 weeks for 10 months'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '10.26', 'spread': '7.54', 'groupId': 'OG000'}, {'value': '5.81', 'spread': '3.38', 'groupId': 'OG001'}]}]}, {'title': 'Mo 3', 'categories': [{'measurements': [{'value': '8.58', 'spread': '5.02', 'groupId': 'OG000'}, {'value': '8.4', 'spread': '5.48', 'groupId': 'OG001'}]}]}, {'title': 'Mo 6', 'categories': [{'measurements': [{'value': '10.24', 'spread': '5.69', 'groupId': 'OG000'}, {'value': '6.86', 'spread': '3.01', 'groupId': 'OG001'}]}]}, {'title': 'Mo 9', 'categories': [{'measurements': [{'value': '10.26', 'spread': '5.57', 'groupId': 'OG000'}, {'value': '8.89', 'spread': '5.69', 'groupId': 'OG001'}]}]}, {'title': 'Mo 12', 'categories': [{'measurements': [{'value': '9.11', 'spread': '4.44', 'groupId': 'OG000'}, {'value': '9.63', 'spread': '5.92', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0241', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.507', 'ciLowerLimit': '0.066', 'ciUpperLimit': '0.947', 'pValueComment': 'The p-value was derived from a statistical model adjusted for age, sex, and BMI', 'statisticalMethod': 'General linear models', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'p values were derived from trend analysis using generalized linear models'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 12 months at 3 months interval', 'description': 'Investigation of the effect of vitamin D supplementation on GLP-1 during PCR.', 'unitOfMeasure': 'ng/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'individuals aged 10-21 years with newly diagnosed T1D in a 12-month RCT of ergocalciferol vs placebo to determine the effect of vitamin D on RBCF and PR in youth with newly diagnosed T1D.'}, {'type': 'SECONDARY', 'title': 'Vitamin D Binding Protein (VDBP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ergocalciferol', 'description': 'Oral administration of 50,000 IU of ergocalciferol one capsule per week for 2 months; and then once every 2 weeks for 10 months in 20 subjects of 10-21yr with newly diagnosed T1D\n\nErgocalciferol: Each subject on the experimental arm will receive one capsule of ergocalciferol per week for 2 months; and then once every 2 weeks for 10 months'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Oral administration of placebo one capsule per week for 2 months; and then once every 2 weeks for 10 months in 20 subjects of 10-21yr with newly diagnosed T1D\n\nPlacebo: Each subject on the placebo arm will receive one capsule of placebo per week for 2 months; and then once every 2 weeks for 10 months'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '134.32', 'spread': '22.82', 'groupId': 'OG000'}, {'value': '111.56', 'spread': '28.82', 'groupId': 'OG001'}]}]}, {'title': 'Mo 3', 'categories': [{'measurements': [{'value': '118.11', 'spread': '27.93', 'groupId': 'OG000'}, {'value': '118.79', 'spread': '22.96', 'groupId': 'OG001'}]}]}, {'title': 'Mo 6', 'categories': [{'measurements': [{'value': '135.32', 'spread': '27.51', 'groupId': 'OG000'}, {'value': '138.18', 'spread': '33.15', 'groupId': 'OG001'}]}]}, {'title': 'Mo 9', 'categories': [{'measurements': [{'value': '135.79', 'spread': '38.47', 'groupId': 'OG000'}, {'value': '131.51', 'spread': '38.86', 'groupId': 'OG001'}]}]}, {'title': 'Mo 12', 'categories': [{'measurements': [{'value': '141.34', 'spread': '32.8', 'groupId': 'OG000'}, {'value': '152.42', 'spread': '31.19', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.23', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '10.37', 'ciLowerLimit': '-6.40', 'ciUpperLimit': '27.13', 'pValueComment': 'The p-value was derived from a statistical model adjusted for age, sex, and BMI', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'p values were obtained from a generalized linear model with repeated measures'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 12 months at 3 months interval', 'description': 'Investigation of the effect of vitamin D supplementation on VDBP during PCR.', 'unitOfMeasure': 'ng/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'individuals aged 10-21 years with newly diagnosed T1D in a 12-month RCT of ergocalciferol vs placebo to determine the effect of vitamin D on RBCF and PR in youth with newly diagnosed T1D.'}, {'type': 'SECONDARY', 'title': 'Effect of Vitamin D Supplementation on the Duration of Partial Clinical Remission (PCR) of Type 1 Diabetes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ergocalciferol', 'description': 'Oral administration of 50,000 IU of ergocalciferol one capsule per week for 2 months; and then once every 2 weeks for 10 months in 20 subjects of 10-21yr with newly diagnosed T1D\n\nErgocalciferol: Each subject on the experimental arm will receive one capsule of ergocalciferol per week for 2 months; and then once every 2 weeks for 10 months'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Oral administration of placebo one capsule per week for 2 months; and then once every 2 weeks for 10 months in 20 subjects of 10-21yr with newly diagnosed T1D\n\nPlacebo: Each subject on the placebo arm will receive one capsule of placebo per week for 2 months; and then once every 2 weeks for 10 months'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '9.9', 'spread': '0.4', 'groupId': 'OG000'}, {'value': '9.4', 'spread': '0.6', 'groupId': 'OG001'}]}]}, {'title': 'Mo 3', 'categories': [{'measurements': [{'value': '9.7', 'spread': '0.6', 'groupId': 'OG000'}, {'value': '8.4', 'spread': '0.4', 'groupId': 'OG001'}]}]}, {'title': 'Mo 6', 'categories': [{'measurements': [{'value': '10.0', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '9', 'spread': '0.5', 'groupId': 'OG001'}]}]}, {'title': 'Mo 9', 'categories': [{'measurements': [{'value': '10.4', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '10.1', 'spread': '0.5', 'groupId': 'OG001'}]}]}, {'title': 'Mo 12', 'categories': [{'measurements': [{'value': '10.6', 'spread': '0.6', 'groupId': 'OG000'}, {'value': '10.7', 'spread': '0.6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'trend analysis', 'ciNumSides': 'TWO_SIDED', 'paramValue': '.02', 'statisticalMethod': 'generalized linear model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'p values were obtained using generalized linear model with GEE for repeated measures.', 'otherAnalysisDescription': 'Trend analysis was obtained using generalized linear model GEE.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to12 months 3 monthly', 'description': 'Insulin dose-adjusted hemoglobin A1c (HbA1c) (IDAA1C)', 'unitOfMeasure': '% of IDAA1c', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'individuals aged 10 to 21 years with newly diagnosed T1D in a 12-month RCT of ergocalciferol vs placebo to determine the effect of vitamin D on RBCF and PR in youth with newly diagnosed T1D.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Ergocalciferol', 'description': 'Oral administration of 50,000 IU of ergocalciferol one capsule per week for 2 months; and then once every 2 weeks for 10 months in 20 subjects of 10-21yr with newly diagnosed T1D\n\nErgocalciferol: Each subject on the experimental arm will receive one capsule of ergocalciferol per week for 2 months; and then once every 2 weeks for 10 months'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Oral administration of placebo one capsule per week for 2 months; and then once every 2 weeks for 10 months in 20 subjects of 10-21yr with newly diagnosed T1D\n\nPlacebo: Each subject on the placebo arm will receive one capsule of placebo per week for 2 months; and then once every 2 weeks for 10 months'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '18'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}], 'preAssignmentDetails': 'Out of 48 enrolled participants, 36 met the inclusion criteria and were randomized to the treatment.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Ergocalciferol', 'description': 'Oral administration of 50,000 IU of ergocalciferol one capsule per week for 2 months; and then once every 2 weeks for 10 months in 20 subjects of 10-21yr with newly diagnosed T1D\n\nErgocalciferol: Each subject on the experimental arm will receive one capsule of ergocalciferol per week for 2 months; and then once every 2 weeks for 10 months'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Oral administration of placebo one capsule per week for 2 months; and then once every 2 weeks for 10 months in 20 subjects of 10-21yr with newly diagnosed T1D\n\nPlacebo: Each subject on the placebo arm will receive one capsule of placebo per week for 2 months; and then once every 2 weeks for 10 months'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '13.25', 'spread': '2.76', 'groupId': 'BG000'}, {'value': '14.28', 'spread': '2.86', 'groupId': 'BG001'}, {'value': '13.77', 'spread': '2.82', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '27', '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': '4', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'HbA1C', 'classes': [{'categories': [{'measurements': [{'value': '7.62', 'spread': '1.35', 'groupId': 'BG000'}, {'value': '7.47', 'spread': '1.69', 'groupId': 'BG001'}, {'value': '7.54', 'spread': '1.52', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Percentage of HbA1C', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body mass index', 'classes': [{'categories': [{'measurements': [{'value': '22.03', 'spread': '5.41', 'groupId': 'BG000'}, {'value': '22.01', 'spread': '4.15', 'groupId': 'BG001'}, {'value': '22.02', 'spread': '4.73', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Fasting plasma glucose', 'classes': [{'categories': [{'measurements': [{'value': '125.83', 'spread': '25', 'groupId': 'BG000'}, {'value': '111.13', 'spread': '35.78', 'groupId': 'BG001'}, {'value': '118.91', 'spread': '30.97', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dl', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Waist Circumference', 'classes': [{'categories': [{'measurements': [{'value': '76.16', 'spread': '14.83', 'groupId': 'BG000'}, {'value': '76.22', 'spread': '11.56', 'groupId': 'BG001'}, {'value': '76.19', 'spread': '13.14', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Height', 'classes': [{'categories': [{'measurements': [{'value': '156.12', 'spread': '12.77', 'groupId': 'BG000'}, {'value': '158.65', 'spread': '11.30', 'groupId': 'BG001'}, {'value': '157.38', 'spread': '11.96', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Height Z-score', 'classes': [{'categories': [{'measurements': [{'value': '0.50', 'spread': '0.73', 'groupId': 'BG000'}, {'value': '0.48', 'spread': '1.18', 'groupId': 'BG001'}, {'value': '0.49', 'spread': '0.96', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'A z-score is the same as standard deviation score; A height z-score of 0 represents the population mean; A z-score above the mean is considered better than a z-score below the mean; A height z-score of \\>2 indicates tall stature, while a height z-score \\<2 indicates short stature', 'unitOfMeasure': 'Z-score', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'weight', 'classes': [{'categories': [{'measurements': [{'value': '53.33', 'spread': '15.19', 'groupId': 'BG000'}, {'value': '56.16', 'spread': '14.66', 'groupId': 'BG001'}, {'value': '54.78', 'spread': '14.77', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Weight z-score', 'classes': [{'categories': [{'measurements': [{'value': '0.86', 'spread': '0.81', 'groupId': 'BG000'}, {'value': '0.67', 'spread': '0.68', 'groupId': 'BG001'}, {'value': '0.76', 'spread': '0.74', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'A z-score is the same as standard deviation score; A weight z-score of 0 represents the population mean; A weight z-score below the mean is considered better than a z-score above the mean; A weight z-score of \\>2 indicates overweight/obesity, while a weight z-score \\<2 indicates underweight', 'unitOfMeasure': 'Z-score', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body mass index z-score', 'classes': [{'categories': [{'measurements': [{'value': '0.89', 'spread': '0.94', 'groupId': 'BG000'}, {'value': '0.74', 'spread': '0.68', 'groupId': 'BG001'}, {'value': '0.82', 'spread': '0.81', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'A z-score is the same as standard deviation score; A BMI z-score of 0 represents the population mean; A BMI z-score below the mean is considered better than a BMI z-score above the mean; A BMI z-score of \\>2 indicates overweight/obesity, while a weight z-score \\<2 indicates underweight', 'unitOfMeasure': 'Z-score', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'systolic blood pressure', 'classes': [{'categories': [{'measurements': [{'value': '104.94', 'spread': '9.06', 'groupId': 'BG000'}, {'value': '106.44', 'spread': '10.60', 'groupId': 'BG001'}, {'value': '105.69', 'spread': '9.74', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmHg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'diastolic blood pressure', 'classes': [{'categories': [{'measurements': [{'value': '64.72', 'spread': '9.14', 'groupId': 'BG000'}, {'value': '64.67', 'spread': '6.80', 'groupId': 'BG001'}, {'value': '64.69', 'spread': '7.94', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmHg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Total Daily Dose (TDD) Insulin', 'classes': [{'categories': [{'measurements': [{'value': '37', 'spread': '29.61', 'groupId': 'BG000'}, {'value': '27.17', 'spread': '14.41', 'groupId': 'BG001'}, {'value': '31.94', 'spread': '23.27', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'units/d', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Total Daily Dose Insulin', 'classes': [{'categories': [{'measurements': [{'value': '0.51', 'spread': '0.23', 'groupId': 'BG000'}, {'value': '0.48', 'spread': '0.23', 'groupId': 'BG001'}, {'value': '0.50', 'spread': '0.23', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'units/kg/d', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Total Daily Dose Long-acting insulin only', 'classes': [{'categories': [{'measurements': [{'value': '18.50', 'spread': '14.81', 'groupId': 'BG000'}, {'value': '14.14', 'spread': '7.30', 'groupId': 'BG001'}, {'value': '16.26', 'spread': '11.60', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'units', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'puberty stage, tanner II-V', 'classes': [{'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-03-28', 'size': 620930, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-04-05T11:35', 'hasProtocol': True}, {'date': '2022-03-28', 'size': 117952, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-04-05T11:36', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Ergocalciferol and placebo will be prepared as identical capsules by Boulevard Pharmaceutical Compounding Center. Randomization will be conducted by the Investigational Drug Services (IDS), UMMS, using a randomization scheme generated by Dr. Barton. Randomization will be 1:1 (ergocalciferol: placebo) and will use a permuted block design with blocking for every 2 or 4 subjects (at random). IDS will maintain blinding information and PI will contact IDS for emergency unblinding.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '12-month randomized, double-blind, placebo-controlled, parallel design trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-10-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2021-04-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-18', 'studyFirstSubmitDate': '2017-02-01', 'resultsFirstSubmitDate': '2022-04-08', 'studyFirstSubmitQcDate': '2017-02-05', 'lastUpdatePostDateStruct': {'date': '2024-07-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-06-18', 'studyFirstPostDateStruct': {'date': '2017-02-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2024-07-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Residual Beta-cell Function (RBCF)', 'timeFrame': 'Baseline to 12 months at 3 months interval', 'description': 'Investigation of the effect of vitamin D on residual beta cell function (RBCF) in the first 12 months after the diagnosis of T1D by using stimulated C-peptide levels to quantify RBCF.'}], 'secondaryOutcomes': [{'measure': 'Change in Percent of HbA1c From Baseline Over Time During Partial Clinical Remission (PCR)', 'timeFrame': 'Baseline to 12 months', 'description': 'Effect of vitamin D supplementation on glycemic control during the partial clinical remission phase as shown by the change in percent HbA1c from baseline across longitudinal measurements at 0, 3, 6, 9, and 12 months.'}, {'measure': 'Glucagon-like Peptide-1 (GLP-1)', 'timeFrame': 'Baseline to 12 months at 3 months interval', 'description': 'Investigation of the effect of vitamin D supplementation on GLP-1 during PCR.'}, {'measure': 'Vitamin D Binding Protein (VDBP)', 'timeFrame': 'Baseline to 12 months at 3 months interval', 'description': 'Investigation of the effect of vitamin D supplementation on VDBP during PCR.'}, {'measure': 'Effect of Vitamin D Supplementation on the Duration of Partial Clinical Remission (PCR) of Type 1 Diabetes', 'timeFrame': 'Baseline to12 months 3 monthly', 'description': 'Insulin dose-adjusted hemoglobin A1c (HbA1c) (IDAA1C)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Type 1 diabetes', 'vitamin D', 'honeymoon phase'], 'conditions': ['Type 1 Diabetes']}, 'descriptionModule': {'briefSummary': 'This project is designed to study the role of vitamin D supplementation on the honeymoon phase of type 1 diabetes in children who are on standardized insulin treatment. The results could lead to significant changes in the approach to the early phase of type 1 diabetes with a strong emphasis on prolonging the honeymoon phase by using vitamin D and maintaining these patients on a standardized insulin regimen. The overall goal is to reduce the long-term complications of type 1 diabetes.', 'detailedDescription': "Prolonging the duration of the partial clinical remission (PCR), or 'honeymoon' phase, of type 1 diabetes (T1D) improves glycemic control and reduces long-term complications. Recent studies suggest the exciting possibility that vitamin D supplementation, a safe and easy-to-implement therapy in children, may lengthen PCR and increase residual beta cell function (RBCF).\n\nHowever, existing studies employed a suboptimal vitamin D dose or lacked a standardized insulin treatment protocol, precluding solid conclusions and preventing the field from moving forward with translation to clinical practice. This trial's rationale is to securely establish the effect of an adequate dose of vitamin D on PCR and RBCF.\n\nWe hypothesize that vitamin D will increase RBCF and prolong PCR. The primary aim is to determine the effect of adjunctive vitamin D on RBCF and PCR in youth with T1D maintained on a standardized insulin protocol. We propose a 12-month randomized, double-blind, placebo-controlled, parallel design trial of ergocalciferol vs. placebo in 40 subjects of 10-21 years with newly-diagnosed T1D. The primary outcome is the change over time in stimulated C-peptide (a measure of RBCF). Secondary outcomes include change over time in insulin-dose-adjusted-hemoglobin-A1c (HbA1c) (IDAA1C; a measure of PCR), HbA1c, and total daily dose of insulin. Mechanistic studies will explore whether beneficial effects of vitamin D are associated with increased GLP-1 levels or decreased inflammatory markers, and whether response to vitamin D is impacted by T1D-risk polymorphisms. If our hypotheses are true, these findings may completely alter the approach to the early management of T1D, with strong emphasis on prolonging the honeymoon phase using a readily available and easily affordable vitamin D while maintaining these patients on a standardized insulin treatment regimen."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '21 Years', 'minimumAge': '10 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age: 10-21 years.\n2. Sex: male and female subjects will be enrolled.\n3. Tanner stage: I-V.\n4. T1D duration of \\<3 months (i.e., from first insulin injection) to ensure the inclusion of patients in PCR.\n5. Presence of at least one diabetes-associated autoantibody.\n6. Normal-weight, overweight-, and obese subjects with T1D\n7. Fasting serum C-peptide level of \\>0.1 nmol/L (0.3 ng/mL)1; or 2-hour post-meal stimulated C-peptide level of 0.2 nmol/L (≥0.6 ng/mL).\n\nExclusion Criteria:\n\n1. Subjects on weight altering medications, such as orlistat.\n2. Subjects with eating disorders\n3. Subjects on medications other than insulin that can affect blood glucose level.\n4. Subjects with 25-hydroxyvitamin D \\[25(OH)D\\] levels of \\>70 ng/mL, as this may lead to vitamin D toxicity in the study subjects.\n5. Subjects with systemic diseases other than T1D.\n6. Subjects with recurrent diabetic ketoacidosis (\\>2 episodes since the diagnosis of T1D or in the preceding 3 months); or \\>2 episodes of severe hypoglycemia in the preceding 3 mo.\n7. Pregnant or breast-feeding female subjects.\n8. The receipt of any investigational drug within 6 months prior to this trial.\n9. Active malignant neoplasm.'}, 'identificationModule': {'nctId': 'NCT03046927', 'acronym': 'PCR', 'briefTitle': 'Vitamin D and Residual Beta-Cell Function in Type 1 Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'University of Massachusetts, Worcester'}, 'officialTitle': 'Vitamin D and Residual Beta-Cell Function in Type 1 Diabetes', 'orgStudyIdInfo': {'id': 'H00010550'}, 'secondaryIdInfos': [{'id': '1R21DK113353', 'link': 'https://reporter.nih.gov/quickSearch/1R21DK113353', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ergocalciferol', 'description': 'Oral administration of 50,000 IU of ergocalciferol one capsule per week for 2 months; and then once every 2 weeks for 10 months in 20 subjects of 10-21yr with newly diagnosed T1D', 'interventionNames': ['Drug: Ergocalciferol']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Oral administration of placebo one capsule per week for 2 months; and then once every 2 weeks for 10 months in 20 subjects of 10-21yr with newly diagnosed T1D', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Ergocalciferol', 'type': 'DRUG', 'otherNames': ['Vitamin D'], 'description': 'Each subject on the experimental arm will receive one capsule of ergocalciferol per week for 2 months; and then once every 2 weeks for 10 months', 'armGroupLabels': ['Ergocalciferol']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Each subject on the placebo arm will receive one capsule of placebo per week for 2 months; and then once every 2 weeks for 10 months', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '01655', 'city': 'Worcester', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'University of Massachusetts Medical School', 'geoPoint': {'lat': 42.26259, 'lon': -71.80229}}], 'overallOfficials': [{'name': 'Benjamin U Nwosu, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Massachusetts, Worcester'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'No.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Benjamin U. Nwosu, MD', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Massachusetts, Worcester', 'class': 'OTHER'}, {'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Benjamin U. Nwosu, MD', 'investigatorAffiliation': 'University of Massachusetts, Worcester'}}}}