Ignite Creation Date:
2025-12-25 @ 2:31 AM
Ignite Modification Date:
2026-02-25 @ 11:38 PM
Study NCT ID:
NCT00570934
Status:
COMPLETED
Last Update Posted:
2016-10-10
First Post:
2007-12-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Supplementation With Vitamin D, Calcium or Both on Calcium Absorption and Bone Mineral Content in Children With JRA
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001171', 'term': 'Arthritis, Juvenile'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002762', 'term': 'Cholecalciferol'}, {'id': 'D002118', 'term': 'Calcium'}], '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'}, {'id': 'D008673', 'term': 'Metals, Alkaline Earth'}, {'id': 'D004602', 'term': 'Elements'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D008670', 'term': 'Metals'}, {'id': 'D001779', 'term': 'Blood Coagulation Factors'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1995-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2002-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-10-07', 'studyFirstSubmitDate': '2007-12-07', 'studyFirstSubmitQcDate': '2007-12-10', 'lastUpdatePostDateStruct': {'date': '2016-10-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-12-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2002-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent true calcium absorption', 'timeFrame': 'After 6 months of treatment'}], 'secondaryOutcomes': [{'measure': 'Bone Mineralization by Dual Energy x-ray absorption', 'timeFrame': 'After 6 months treatment plus 3 month washout'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Juvenile Rheumatoid Arthritis']}, 'referencesModule': {'references': [{'pmid': '18821668', 'type': 'DERIVED', 'citation': 'Hillman LS, Cassidy JT, Chanetsa F, Hewett JE, Higgins BJ, Robertson JD. Percent true calcium absorption, mineral metabolism, and bone mass in children with arthritis: effect of supplementation with vitamin D3 and calcium. Arthritis Rheum. 2008 Oct;58(10):3255-63. doi: 10.1002/art.23809.'}]}, 'descriptionModule': {'briefSummary': '2000 international units (IU) vitamin D, 1 gram (gm) calcium, or both given to children with Juvenile Rheumatoid Arthritis (JRA) may increase percent true calcium absorption, bone mineral turnover and/or bone mineralization.', 'detailedDescription': 'Supplementation With 2000 IU Vitamin D, 1 gm Calcium or Both on Calcium Absorption and Bone Mineralization in Children With Juvenile Rheumatoid Arthritis may increase percent true calcium absorption, bone mineral turnover and/or bone mineralization.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '15 Years', 'minimumAge': '3 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Juvenile Rheumatoid arthritis\n\nExclusion Criteria:\n\n* Steroid use'}, 'identificationModule': {'nctId': 'NCT00570934', 'briefTitle': 'Supplementation With Vitamin D, Calcium or Both on Calcium Absorption and Bone Mineral Content in Children With JRA', 'organization': {'class': 'OTHER', 'fullName': 'University of Missouri-Columbia'}, 'officialTitle': 'Effect of Supplementation With 2000 International Units (IU) Vitamin D, 1gm Calcium or Both on Calcium Absorption and Bone Mineralization in Children With Juvenile Rheumatoid Arthritis', 'orgStudyIdInfo': {'id': '5387'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Placebo', 'description': 'order of interventions placebo,calcium, cholecalciferol, calcium plus cholecalciferol', 'interventionNames': ['Dietary Supplement: Cholecalciferol', 'Dietary Supplement: Calcium', 'Dietary Supplement: Calcium and cholecalciferol', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Calcium', 'description': 'order of treatment calcium, placebo, calcium plus cholecalciferol, cholecalciferol', 'interventionNames': ['Dietary Supplement: Cholecalciferol', 'Dietary Supplement: Calcium', 'Dietary Supplement: Calcium and cholecalciferol', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Cholecalciferol', 'description': 'order of treatments cholecalciferol, calcium and Cholecalciferol, placebo, and calcium', 'interventionNames': ['Dietary Supplement: Cholecalciferol', 'Dietary Supplement: Calcium', 'Dietary Supplement: Calcium and cholecalciferol', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Calcium and cholecalciferol', 'description': 'order of treatment calcium and cholecalciferol, cholecalciferol, calcium, placebo', 'interventionNames': ['Dietary Supplement: Cholecalciferol', 'Dietary Supplement: Calcium', 'Dietary Supplement: Calcium and cholecalciferol', 'Drug: Placebo']}], 'interventions': [{'name': 'Cholecalciferol', 'type': 'DIETARY_SUPPLEMENT', 'description': '2000IU Cholecalciferol P.O. Q.D.', 'armGroupLabels': ['Calcium', 'Calcium and cholecalciferol', 'Cholecalciferol', 'Placebo']}, {'name': 'Calcium', 'type': 'DIETARY_SUPPLEMENT', 'description': '1 gm calcium as calcium carbonate', 'armGroupLabels': ['Calcium', 'Calcium and cholecalciferol', 'Cholecalciferol', 'Placebo']}, {'name': 'Calcium and cholecalciferol', 'type': 'DIETARY_SUPPLEMENT', 'description': '2000IU cholecalciferol and 1 gm calcium P.O. Q.D. for 6 months', 'armGroupLabels': ['Calcium', 'Calcium and cholecalciferol', 'Cholecalciferol', 'Placebo']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo', 'armGroupLabels': ['Calcium', 'Calcium and cholecalciferol', 'Cholecalciferol', 'Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '65203', 'city': 'Columbia', 'state': 'Missouri', 'country': 'United States', 'facility': 'University of Missouri Hospitals and clinics', 'geoPoint': {'lat': 38.95171, 'lon': -92.33407}}], 'overallOfficials': [{'name': 'Laura S Hillman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Missouri-Columbia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Missouri-Columbia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}