Ignite Creation Date:
2025-12-25 @ 4:26 AM
Ignite Modification Date:
2026-04-27 @ 1:54 PM
Study NCT ID:
NCT00491920
Status:
COMPLETED
Last Update Posted:
2011-11-03
First Post:
2007-06-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
High Dosage Vitamin D and Osteoporosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010024', 'term': 'Osteoporosis'}, {'id': 'D001851', 'term': 'Bone Diseases, Metabolic'}], 'ancestors': [{'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, '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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 297}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-11', 'completionDateStruct': {'date': '2010-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-11-02', 'studyFirstSubmitDate': '2007-06-25', 'studyFirstSubmitQcDate': '2007-06-25', 'lastUpdatePostDateStruct': {'date': '2011-11-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-06-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'changes in bone mineral density in columna and total hip.', 'timeFrame': 'One year'}], 'secondaryOutcomes': [{'measure': 'Muscle strength (hand grip strength and knee extension)', 'timeFrame': 'One year'}, {'measure': 'balance (tandem test)', 'timeFrame': 'One year'}, {'measure': 'body composition (Dexa)', 'timeFrame': 'One year'}, {'measure': 'inflammation markers', 'timeFrame': 'One year'}, {'measure': 'calcium and vitamin D metabolism', 'timeFrame': 'One year'}, {'measure': 'blood lipids', 'timeFrame': 'One year'}, {'measure': 'renal function', 'timeFrame': 'One year'}, {'measure': 'telomere length', 'timeFrame': 'one year'}, {'measure': 'perception of own health', 'timeFrame': 'one year'}, {'measure': 'Urinary tract symptoms', 'timeFrame': 'one year'}, {'measure': 'effects of polymorphisms in VDR on the other endpoints', 'timeFrame': 'one year'}, {'measure': 'side effects', 'timeFrame': 'one year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['osteoporosis', 'bone mineral density', 'vitamin D'], 'conditions': ['Osteoporosis', 'Osteopenia']}, 'descriptionModule': {'briefSummary': 'Vitamin D and calcium are essential in the treatment and prevention of osteoporosis. What dosage of vitamin D which is the ideal one, is not yet clear. We want to test the hypothesis that high dosage of vitamin D (i.e. 6500 IU/d) is better than standard dosage (800 IU/d) in a randomized double-blind trial. We will include 400 postmenopausal otherwise healthy women with T-score \\<= -2.0 in L2-4 or mean total hip. Everybody will receive calcium 1000 mg and vitamin D 800 IU every day. Half of the group will also receive vitamin D 40 000 IU/week, while the other half will have placebo. The study period is one year.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* bone mineral density in L2-4 or mean total hip with T-score \\<= -2.0\n\nExclusion Criteria:\n\n* current use of bisphosphonates, PTH-analogs, estrogen, SERM, p.o. steroids or use of any of these agents last year\n* serum creatinin \\>110 umol/L\n* systolic blood pressure \\>175 mmHg or diastolic blod pressure \\>105\n* serious disease (heart failure, angina pectoris, myocardial infarction, diabetes, mental reduction, granulomatous disease like sarcoidosis, cancer)\n* kidney stone\n* serum calcium \\> 2.55 mmol/L\n* suspect primary hyperparathyroidism with serum calcium \\>2.50 mmol/L combined with PTH \\> 5.0 mmol/L or serum calcium \\> 2.45 mmol/L combined with PTH \\>= 7.0 pmol/L'}, 'identificationModule': {'nctId': 'NCT00491920', 'briefTitle': 'High Dosage Vitamin D and Osteoporosis', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital of North Norway'}, 'officialTitle': 'High Dosage Vitamin D in the Treatment of Osteoporosis in Postmenopausal Women', 'orgStudyIdInfo': {'id': '2006-003186-14'}}, 'armsInterventionsModule': {'interventions': [{'name': 'cholecalciferol (Vitamin D3)', 'type': 'DRUG', 'description': '20 000 Iu x2/week\n\n\\+ calcium 500 mg/cholecalciferol 400 IU x2/d'}, {'name': 'placebo', 'type': 'DRUG', 'description': 'Calcium 500 mg/Cholecalciferol 400 IU x2/d and placebo 2/w'}]}, 'contactsLocationsModule': {'locations': [{'zip': '9012', 'city': 'Tromsø', 'country': 'Norway', 'facility': 'Medical Dpt. B, University Hospital of Northern Norway', 'geoPoint': {'lat': 69.6489, 'lon': 18.95508}}], 'overallOfficials': [{'name': 'Rolf Jorde, Ph.D, M.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical Dpt, University Hospital of Northern Norway'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital of North Norway', 'class': 'OTHER'}, 'collaborators': [{'name': 'Norske Kvinners Sanitetsforening Troms', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}