Ignite Creation Date:
2025-12-24 @ 3:51 PM
Ignite Modification Date:
2025-12-26 @ 2:41 PM
Study NCT ID:
NCT01029392
Status:
COMPLETED
Last Update Posted:
2017-04-17
First Post:
2009-12-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Prevalence of Vitamin D Deficiency in Type 1 Diabetes Mellitus and Effect of Supplementation on Insulin Requirements
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'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': 'D014807', 'term': 'Vitamin D'}, {'id': 'D002762', 'term': 'Cholecalciferol'}], 'ancestors': [{'id': 'D012632', 'term': 'Secosteroids'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D002782', 'term': 'Cholestenes'}, {'id': 'D002776', 'term': 'Cholestanes'}, {'id': 'D013261', 'term': 'Sterols'}, {'id': 'D008563', 'term': 'Membrane Lipids'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'peter.gerrits@beaumont.org', 'phone': '248-551-0487', 'title': 'Dr. Peter Gerrits', 'organization': 'William Beaumont Hospital'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '6 months', 'eventGroups': [{'id': 'EG000', 'title': 'Those Requiring Vit D Supplement', 'description': 'Those who had a Vit D level of \\< 30 ng/mL Vitamin D: 2000iu once a day', 'otherNumAtRisk': 37, 'deathsNumAtRisk': 37, 'otherNumAffected': 0, 'seriousNumAtRisk': 37, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'No Vit D Supplementation', 'description': 'Normal vitamin D levels (50-80 ng/mL) No vitamin D supplementation', 'otherNumAtRisk': 38, 'deathsNumAtRisk': 38, 'otherNumAffected': 0, 'seriousNumAtRisk': 38, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'seriousEvents': [{'term': 'Increased dose of Vitamin D needed', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Hemoglobin A1c', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Those Requiring Vit D Supplement', 'description': 'Those who had a Vit D level of \\< 30 Vitamin D: 2000iu once a day'}, {'id': 'OG001', 'title': 'No Vitamin D Supplementation', 'description': 'Those with normal vitamin D levels (50-80 ng/mL) No vitamin D supplemenation'}], 'classes': [{'categories': [{'measurements': [{'value': '2.67', 'spread': '0.58', 'groupId': 'OG000'}, {'value': '1.05', 'spread': '0.58', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'Change in hemoglobin A1c calculated as a percentage change from baseline measurement', 'unitOfMeasure': 'percentage change from baseline', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '20 patients in the Vitamin D Supplement arm and 11 patients in the No-Vitamin D supplement arm were withdrawn and not analyzed.'}, {'type': 'SECONDARY', 'title': 'Change in Insulin Requirements', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vitamin D Supplement', 'description': 'Those who had a Vit D level of \\< 30 ng/mKL\n\nVitamin D: 2000 IU once a day'}, {'id': 'OG001', 'title': 'No Vitamin D Supplementation', 'description': 'Screening vitamin D level in normal range for children (50-80 ng.mL)'}], 'classes': [{'categories': [{'measurements': [{'value': '2.62', 'spread': '4.05', 'groupId': 'OG000'}, {'value': '1.80', 'spread': '1.55', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'Percentage change from baseline number of units of lantus insulin over 6 months.', 'unitOfMeasure': 'percentage change of baseline insulin', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '20 patients in the Vitamin D Supplement arm and 11 patients in the No-Vitamin D supplement arm were withdrawn and not analyzed.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Vitamin D Supplement', 'description': 'Those who had a Vit D level of \\< 30 ng/mKL\n\nVitamin D: 2000 IU once a day'}, {'id': 'FG001', 'title': 'No Vitamin D Supplementation', 'description': 'Screening vitamin D level in normal range for children (50-80 ng.mL)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '37'}, {'groupId': 'FG001', 'numSubjects': '38'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '27'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '11'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'Blood vitamin D level checked to assign to treatment or no-treatment arm'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '75', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Those Requiring Vit D Supplement', 'description': 'Those who had a Vit D level of \\< 30\n\nVitamin D: 2000iu once a day'}, {'id': 'BG001', 'title': 'No Vit D Supplementation', 'description': 'Normal vitamin D levels No Vitamin D supplement'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': '20 patients in the Vitamin D Supplement arm and 11 patients in the No-Vitamin D supplement arm were withdrawn and not analyzed.'}, {'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '75', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '10.4', 'spread': '4.2', 'groupId': 'BG000'}, {'value': '8.9', 'spread': '4.1', 'groupId': 'BG001'}, {'value': '9.95', 'spread': '4.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '75', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '75', 'groupId': 'BG002'}]}], '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': '7', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '59', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '75', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '75', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Patients with clinically significantly low Vitamin D levels (\\<30 ng/mL) were supplemented with Vitamin D and compared to patients with normal vitamin D levels (50-80 nG/mL).'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 75}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-12', 'completionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-03', 'studyFirstSubmitDate': '2009-12-09', 'resultsFirstSubmitDate': '2016-12-13', 'studyFirstSubmitQcDate': '2009-12-09', 'lastUpdatePostDateStruct': {'date': '2017-04-17', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-03-03', 'studyFirstPostDateStruct': {'date': '2009-12-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-04-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Hemoglobin A1c', 'timeFrame': '6 months', 'description': 'Change in hemoglobin A1c calculated as a percentage change from baseline measurement'}], 'secondaryOutcomes': [{'measure': 'Change in Insulin Requirements', 'timeFrame': '6 months', 'description': 'Percentage change from baseline number of units of lantus insulin over 6 months.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Diabetes', 'Type I', 'Newly Diagnosis Type I Diabetes Mellitus'], 'conditions': ['Type 1 Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'Our objective is to demonstrate that providing supplemental vitamin D to children with new onset DM will significantly decrease the levels of HbA1c and insulin requirement by the following methods.\n\n1. Identify how often vitamin D levels are low in patients with new onset Type 1 diabetes mellitus (DM).\n2. Record the hemoglobin A1c (HbA1c) level (which reflects the average blood sugar level over the past few months) and document insulin requirements before and after vitamin supplementation is given.\n\nHypothesis: Maintaining vitamin D levels \\>30 ng/ml will decrease HbA1c and insulin requirements.', 'detailedDescription': 'New onset type 1 DM patients who present at William Beaumont Hospital, Royal Oak or to the Pediatric Endocrine Clinic will be approached about the study at their presentation and time will be given for the patient and family to discuss and ask questions regarding the study. Patients will then be enrolled following informed consent. Glucose levels and insulin requirements will be monitored continuously from the faxed weekly logbooks from the point of diagnosis for 3 months (as standard practice for all newly diagnosed diabetic patients in our clinic). At the baseline visit a Vitamin D level will be drawn and frozen for 3 months prior to processing. .After 3 months vitamin D, calcium, alkaline phosphatase, phosphorus and other standard of care lab draws will be done. Approximately an additional 3 tsp of blood will be taken. All female subjects of child bearing potential will have a pregnancy test done. EMLA cream to anesthetize the area will be used prior to blood draw. A vitamin D level of \\<30 ng/ml is considered insufficient and the patient will then be given vitamin D supplement. The vitamin D level, calcium, alkaline phosphatase and phosphorus will be rechecked at 6 months (additional 3 tsp of blood) . Glucose levels and insulin requirements will be monitored continuously from the faxed weekly logbooks again for another 3 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '1 Year', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Newly diagnosed type I DM.\n* Age \\<18 years\n\nExclusion Criteria:\n\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT01029392', 'briefTitle': 'Prevalence of Vitamin D Deficiency in Type 1 Diabetes Mellitus and Effect of Supplementation on Insulin Requirements', 'organization': {'class': 'OTHER', 'fullName': 'Corewell Health East'}, 'officialTitle': 'Prevalence of Vitamin D Deficiency in Type 1 Diabetes Mellitus and Effect on Insulin Requirements After Supplementation With Vitamin D-A Pilot Study', 'orgStudyIdInfo': {'id': '2009-189'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Required Vitamin D', 'description': 'Those children whose Vitamin D level was low (\\<30 ng/mL) are given Vitamin D supplementation', 'interventionNames': ['Drug: Vitamin D']}, {'type': 'NO_INTERVENTION', 'label': 'Normal Vitamin D', 'description': 'Those children whose Vitamin D level was normal (50-80 ng/mL) did not receive Vitamin D supplementation'}], 'interventions': [{'name': 'Vitamin D', 'type': 'DRUG', 'otherNames': ['cholecalciferol'], 'description': '2000iu once a day', 'armGroupLabels': ['Required Vitamin D']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48073', 'city': 'Royal Oak', 'state': 'Michigan', 'country': 'United States', 'facility': 'WilliamBH', 'geoPoint': {'lat': 42.48948, 'lon': -83.14465}}], 'overallOfficials': [{'name': 'Peter Gerrits, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Corewell Health East'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'No data sharing.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Corewell Health East', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Peter Gerrits, MD', 'investigatorAffiliation': 'Corewell Health East'}}}}