Ignite Creation Date:
2025-12-25 @ 1:44 AM
Ignite Modification Date:
2026-01-07 @ 5:48 PM
Study NCT ID:
NCT00685594
Status:
COMPLETED
Last Update Posted:
2015-09-22
First Post:
2008-05-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vitamin D for the Prevention of Diabetes Type 2
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018149', 'term': 'Glucose Intolerance'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D006943', 'term': 'Hyperglycemia'}, {'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'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 511}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'completionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-09-18', 'studyFirstSubmitDate': '2008-05-09', 'studyFirstSubmitQcDate': '2008-05-27', 'lastUpdatePostDateStruct': {'date': '2015-09-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-05-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Oral glucose tolerance response to vitamin D supplementation in relation to polymorphisms in the vitamin D system', 'timeFrame': '1 year', 'description': 'The response to oral glucose tolerance test (fasting and 2 h blood glucose, serum insulin, C-peptide, measures of insulin resistiance as well as metabolic parameters (lipids, blood pressure)) will be evaluated in the results at the 1-year visit in relation to genetic polymorphisms in the vitamin D system'}], 'primaryOutcomes': [{'measure': 'development of diabetes type 2', 'timeFrame': '5 years'}], 'secondaryOutcomes': [{'measure': 'change in glucose metabolism', 'timeFrame': '5 years'}, {'measure': 'change in lipid status', 'timeFrame': '5 years'}, {'measure': 'change in mood', 'timeFrame': '5 years'}, {'measure': 'change in BMD hip', 'timeFrame': '5 years'}, {'measure': 'change in intima media thickness carotid artery', 'timeFrame': '5 years'}, {'measure': 'change in frequency of infections', 'timeFrame': '5 years'}, {'measure': 'change in blood pressure', 'timeFrame': '5 years'}, {'measure': 'Change in Insulin sensitivity', 'timeFrame': '5 years'}, {'measure': 'change in HbA1c', 'timeFrame': '5 years'}, {'measure': 'change in weight', 'timeFrame': '5 years'}, {'measure': 'change in telomer length', 'timeFrame': '5 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['diabetes', 'vitamin D', 'cholecalciferol', 'glucose tolerance'], 'conditions': ['Impaired Glucose Tolerance']}, 'referencesModule': {'references': [{'pmid': '26829443', 'type': 'DERIVED', 'citation': 'Jorde R, Sollid ST, Svartberg J, Schirmer H, Joakimsen RM, Njolstad I, Fuskevag OM, Figenschau Y, Hutchinson MY. Vitamin D 20,000 IU per Week for Five Years Does Not Prevent Progression From Prediabetes to Diabetes. J Clin Endocrinol Metab. 2016 Apr;101(4):1647-55. doi: 10.1210/jc.2015-4013. Epub 2016 Feb 1.'}]}, 'descriptionModule': {'briefSummary': 'The prevalence of type 2 diabetes is increasing, which for most societies has considerable consequences not only regarding health but also economy. Type 2 diabetes develops through a "prediabetic" stage with impaired glucose tolerance. Intervention at this stage with change in lifestyle or with medication may prevent such progression. There are indications that vitamin D is of importance in glucose metabolism, and that supplementation with vitamin D may increase both insulin secretion and insulin sensitivity. Accordingly, supplementation with vitamin D may improve glucose tolerance and potentially prevent the development of type 2 diabetes in subjects at risk. However, this has so far not been demonstrated in a prospective, randomised clinical study. In the present study we will therefore include 600 subjects with impaired glucose tolerance (or impaired fasting glucose) detected in the Tromso study 2007/2008 and randomize to supplementation with vitamin D 20.000IU per week or placebo for 5 years. A glucose tolerance test will be performed each year, and development of type 2 diabetes will be the main endpoint.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Impaired glucose tolerance\n\nExclusion Criteria:\n\n* Serious heart disease\n* Renal stone disease\n* Hypercalcemia\n* Sarcoidosis'}, 'identificationModule': {'nctId': 'NCT00685594', 'briefTitle': 'Vitamin D for the Prevention of Diabetes Type 2', 'organization': {'class': 'OTHER', 'fullName': 'University of Tromso'}, 'officialTitle': 'Prevention of Type 2 Diabetes With Vitamin D Supplementation in Subjects With Reduced Glucose Tolerance Detected in the Tromso Study 2007/2008', 'orgStudyIdInfo': {'id': 'UIT-ENDO-2008-1'}, 'secondaryIdInfos': [{'id': 'NFR 184766/V50'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Cholecalciferol 20.000 IU per week for 5 years', 'interventionNames': ['Drug: cholecalciferol']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'cholecalciferol', 'type': 'DRUG', 'otherNames': ['vitamin D'], 'description': '20.000 IU cholecalciferol per week for 5 years versus placebo', 'armGroupLabels': ['1']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo capsule once a week, identical to cholecalciferol capsule', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9037', 'city': 'Tromsø', 'country': 'Norway', 'facility': 'University of Tromso', 'geoPoint': {'lat': 69.6489, 'lon': 18.95508}}], 'overallOfficials': [{'name': 'Rolf Jorde, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Tromso'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Tromso', 'class': 'OTHER'}, 'collaborators': [{'name': 'University Hospital of North Norway', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}