Ignite Creation Date:
2025-12-24 @ 11:19 PM
Ignite Modification Date:
2026-01-25 @ 7:02 AM
Study NCT ID:
NCT00243256
Status:
COMPLETED
Last Update Posted:
2008-05-14
First Post:
2005-10-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment of Obesity With Vitamin D (40.000 IE Per Week for 1 Year)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, '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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 450}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-05', 'completionDateStruct': {'date': '2007-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-05-08', 'studyFirstSubmitDate': '2005-10-20', 'studyFirstSubmitQcDate': '2005-10-20', 'lastUpdatePostDateStruct': {'date': '2008-05-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-10-21', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Body Weight'}, {'measure': 'Body composition'}, {'measure': 'Measures of calcium metabolism'}, {'measure': 'Insulin sensitivity'}, {'measure': 'Muscle strength'}, {'measure': 'Depression score'}, {'measure': 'Blood pressure'}]}, 'conditionsModule': {'conditions': ['Obesity']}, 'referencesModule': {'references': [{'pmid': '20056003', 'type': 'DERIVED', 'citation': 'Jorde R, Sneve M, Torjesen PA, Figenschau Y, Hansen JB, Grimnes G. No significant effect on bone mineral density by high doses of vitamin D3 given to overweight subjects for one year. Nutr J. 2010 Jan 7;9:1. doi: 10.1186/1475-2891-9-1.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to evaluate if supplementation with vitamin D in doses of 20.000IU per week and 40.000 IU per week will result in weight loss in obese subjects as compared to placebo during 1 year.', 'detailedDescription': 'We will include 450 obese subjects that will be devided in 3 groups: 40.000IU cholecalciferol per week, 20.000 IU cholecalciferol per week, and placebo. All subjects will be given 500 mg calcium per day. There will be visits every tird month. In addition to weight reduction, we will also evaluate the calcium metabolism (blood test and urin samples), insulin sensitivity, muscle strenght, blood pressure and depression.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* BMI 30 - 40\n* serum calcium \\< 2.55 mmol/L\n\nExclusion Criteria:\n\n* serious diseases\n* reduced kidney function\n* renal stone disease\n* using psychopharmaca\n* using drugs for weight reduction'}, 'identificationModule': {'nctId': 'NCT00243256', 'briefTitle': 'Treatment of Obesity With Vitamin D (40.000 IE Per Week for 1 Year)', 'organization': {'class': 'OTHER', 'fullName': 'University of Tromso'}, 'orgStudyIdInfo': {'id': 'CSEMDT-2005-2'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Cholecalciferol', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '9038', 'city': 'Tromsø', 'country': 'Norway', 'facility': 'Clinical Research Unit, University Hospital of North Norway', 'geoPoint': {'lat': 69.6489, 'lon': 18.95508}}], 'overallOfficials': [{'name': 'Rolf Jorde, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Tromsø, Tromsø, Norway'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Tromso', 'class': 'OTHER'}}}}