Ignite Creation Date:
2025-12-25 @ 4:59 AM
Ignite Modification Date:
2025-12-26 @ 3:59 AM
Study NCT ID:
NCT00749918
Status:
COMPLETED
Last Update Posted:
2008-10-20
First Post:
2008-09-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Vitamin D Deficiency and Vitamin D Supplementation on Glucose Metabolism
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011236', 'term': 'Prediabetic State'}, {'id': 'D014808', 'term': 'Vitamin D Deficiency'}, {'id': 'D007333', 'term': 'Insulin Resistance'}], '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': 'D001361', 'term': 'Avitaminosis'}, {'id': 'D003677', 'term': 'Deficiency Diseases'}, {'id': 'D044342', 'term': 'Malnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}]}, '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-10', 'completionDateStruct': {'date': '2008-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-10-16', 'studyFirstSubmitDate': '2008-09-08', 'studyFirstSubmitQcDate': '2008-09-08', 'lastUpdatePostDateStruct': {'date': '2008-10-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-09-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessment of insulin sensitivity before and after oral vitamin D3 supplementation with 10,000 IU/day for one month.', 'timeFrame': 'At baseline and after 4 weeks of vitamin D supplementation'}], 'secondaryOutcomes': [{'measure': 'Monitor effect of vitamin D supplementation with 10,000 IU/day for one month on serum calcium and parathyroid hormone levels.', 'timeFrame': 'One month'}, {'measure': 'Assess effect of vitamin D supplementation on beta cell function as measured by analysis of data collected through a modified FSIGT test.', 'timeFrame': 'One month'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['vitamin D', 'Cholecalciferol', 'Insulin sensitivity', 'MinMod Millennium', 'FSIGT', 'modified frequently sampled IV glucose tolerance test'], 'conditions': ['Prediabetes', 'Vitamin D Deficiency']}, 'descriptionModule': {'briefSummary': 'This study was intended to evaluate the effect of vitamin D supplementation on insulin sensitivity and pancreatic islet beta-cell function. Our hypothesis was that vitamin D supplementation to normal levels in patients with impaired fasting glucose will result in improved insulin sensitivity and improved beta cell function.', 'detailedDescription': 'A modified frequently sampled intravenous glucose tolerance (mFSIGT) test was used. On day 0, baseline 22 time point mFSIGT was performed. Subjects were then treated with cholecalciferol (vitamin D3) supplementation - 10,000 IU/day - for 28 consecutive days. mFSIGT was then repeated measuring glucose, insulin and c-peptide at all time points. 25-OH vitamin D, PTH, and calcium were also measured at time point 0 pre and post vitamin D supplementation. Data was analyzed using the Bergman/Boston minimal model for insulin homeostasis with MinMod Millennium software.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Impaired fasting glucose\n* Adult, age between 18 and 65\n* Serum vitamin D level below 30 ng/mL\n\nExclusion Criteria:\n\n* History of nephrolithiasis\n* Any medications that can effect insulin sensitivity or beta cell function (i.e. antipsychotics, metformin)\n* Pregnancy\n* Liver disease\n* Renal disease'}, 'identificationModule': {'nctId': 'NCT00749918', 'briefTitle': 'Effect of Vitamin D Deficiency and Vitamin D Supplementation on Glucose Metabolism', 'organization': {'class': 'OTHER', 'fullName': 'University of Minnesota'}, 'officialTitle': 'Improved Insulin Sensitivity With Therapeutic Vitamin D Replacement in Pre-Diabetic Vitamin D Deficient Individuals', 'orgStudyIdInfo': {'id': '0609M92006'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Each subject was evaluated and data was collected before and after the intervention', 'interventionNames': ['Dietary Supplement: Cholecalciferol (vitamin D3)']}], 'interventions': [{'name': 'Cholecalciferol (vitamin D3)', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Cholecalciferol by BIO-TECH Pharmacal, Inc.'], 'description': 'Oral capsules of cholecalciferol, 5000 IU/ capsule, two capsules daily for one month.', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55455', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'University of Minnesota, Division of Endocrinology', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}], 'overallOfficials': [{'name': 'Cary Mariash, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Minnesota'}, {'name': 'Shaban Nazarian, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Minnesota'}, {'name': 'Sidney Jones, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Minnesota'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Minnesota', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hennepin Healthcare Research Institute', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Shaban Nazarian', 'oldOrganization': 'University of Minnesota'}}}}