Ignite Creation Date:
2025-12-25 @ 12:03 AM
Ignite Modification Date:
2025-12-25 @ 10:01 PM
Study NCT ID:
NCT00423358
Status:
COMPLETED
Last Update Posted:
2015-08-24
First Post:
2007-01-17
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Treatment of Hypovitaminosis D in Rheumatoid Arthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}, {'id': 'D014808', 'term': 'Vitamin D Deficiency'}], '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'}, {'id': 'D001361', 'term': 'Avitaminosis'}, {'id': 'D003677', 'term': 'Deficiency Diseases'}, {'id': 'D044342', 'term': 'Malnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014807', 'term': 'Vitamin D'}, {'id': 'D004872', 'term': 'Ergocalciferols'}], 'ancestors': [{'id': 'D012632', 'term': 'Secosteroids'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D002782', 'term': 'Cholestenes'}, {'id': 'D002776', 'term': 'Cholestanes'}, {'id': 'D013261', 'term': 'Sterols'}, {'id': 'D008563', 'term': 'Membrane Lipids'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'keh@medicine.wisc.edu', 'phone': '608-263-3457', 'title': 'Karen E Hansen, MD, MS', 'organization': 'University of Wisconsin'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were queried through specific and open ended questions at each study visit. All AEs after randomization were counted and reported.', 'eventGroups': [{'id': 'EG000', 'title': 'Vitamin D, n=11', 'description': 'ergocalciferol 50,000 IU Twice monthly\n\nVitamin D: Ergocalciferol 50,000 IU loading dose then twice monthly for one year', 'otherNumAtRisk': 11, 'otherNumAffected': 1, 'seriousNumAtRisk': 11, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo, n=11', 'description': 'matching placebo tablet\n\nplacebo: matching placebo', 'otherNumAtRisk': 11, 'otherNumAffected': 0, 'seriousNumAtRisk': 11, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'GI', 'notes': 'One participant in the treatment arm reported stomach cramping and constipation that resolved within two weeks of stopping calcium supplements, despite continuation of vitamin D therapy.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'table'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Parathyroid Hormone Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vitamin D, n=11', 'description': 'ergocalciferol 50,000 IU Twice monthly\n\nVitamin D: Ergocalciferol 50,000 IU loading dose then twice monthly for one year'}, {'id': 'OG001', 'title': 'Placebo, n=11', 'description': 'matching placebo tablet\n\nplacebo: matching placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '19', 'spread': '11', 'groupId': 'OG000'}, {'value': '20', 'spread': '11', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 Year', 'description': 'Serum parathyroid hormone level', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Subject data were analyzed using the intent to treat approach.'}, {'type': 'SECONDARY', 'title': 'Bone Mineral Density', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vitamin D, n=11', 'description': 'ergocalciferol 50,000 IU Twice monthly\n\nVitamin D: Ergocalciferol 50,000 IU loading dose then twice monthly for one year'}, {'id': 'OG001', 'title': 'Placebo, n=11', 'description': 'matching placebo tablet\n\nplacebo: matching placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '0.970', 'spread': '0.140', 'groupId': 'OG000'}, {'value': '1.151', 'spread': '0.168', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 Year', 'description': 'one year change in mean total hip BMD', 'unitOfMeasure': 'g/cm2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat analysis'}, {'type': 'SECONDARY', 'title': 'Short Form 36 Survey', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vitamin D, n=11', 'description': 'ergocalciferol 50,000 IU Twice monthly\n\nVitamin D: Ergocalciferol 50,000 IU loading dose then twice monthly for one year'}, {'id': 'OG001', 'title': 'Placebo, n=11', 'description': 'matching placebo tablet\n\nplacebo: matching placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '39.1', 'groupId': 'OG000', 'lowerLimit': '34.0', 'upperLimit': '44.4'}, {'value': '47.7', 'groupId': 'OG001', 'lowerLimit': '42.5', 'upperLimit': '52.9'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 Year', 'description': '12 month score for physical function domain of SF36 survey; scale 0 to 100 with 0 indicating worst disability and 100 indicating best physical function', 'unitOfMeasure': 'units from 0 (worst) to 100 (best)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat analysis'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Vitamin D', 'description': 'ergocalciferol 50,000 IU Twice monthly\n\nVitamin D: Ergocalciferol 50,000 IU loading dose then twice monthly for one year'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'matching placebo tablet\n\nplacebo: matching placebo'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Vitamin D', 'description': 'ergocalciferol 50,000 IU Twice monthly\n\nVitamin D: Ergocalciferol 50,000 IU loading dose then twice monthly for one year'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'matching placebo tablet\n\nplacebo: matching placebo'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '63', 'spread': '12', 'groupId': 'BG000'}, {'value': '53', 'spread': '11', 'groupId': 'BG001'}, {'value': '58', 'spread': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-07', 'completionDateStruct': {'date': '2009-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-07-27', 'studyFirstSubmitDate': '2007-01-17', 'resultsFirstSubmitDate': '2015-05-29', 'studyFirstSubmitQcDate': '2007-01-17', 'lastUpdatePostDateStruct': {'date': '2015-08-24', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-07-27', 'studyFirstPostDateStruct': {'date': '2007-01-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-08-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Parathyroid Hormone Level', 'timeFrame': '1 Year', 'description': 'Serum parathyroid hormone level'}], 'secondaryOutcomes': [{'measure': 'Bone Mineral Density', 'timeFrame': '1 Year', 'description': 'one year change in mean total hip BMD'}, {'measure': 'Short Form 36 Survey', 'timeFrame': '1 Year', 'description': '12 month score for physical function domain of SF36 survey; scale 0 to 100 with 0 indicating worst disability and 100 indicating best physical function'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['rheumatoid arthritis', 'hypovitaminosis D', 'bone turnover', 'ergocalciferol'], 'conditions': ['Rheumatoid Arthritis', 'Hypovitaminosis D']}, 'referencesModule': {'references': [{'pmid': '18302509', 'type': 'RESULT', 'citation': 'Hansen KE, Jones AN, Lindstrom MJ, Davis LA, Engelke JA, Shafer MM. Vitamin D insufficiency: disease or no disease? J Bone Miner Res. 2008 Jul;23(7):1052-60. doi: 10.1359/jbmr.080230.'}, {'pmid': '24561419', 'type': 'RESULT', 'citation': 'Hansen KE, Bartels CM, Gangnon RE, Jones AN, Gogineni J. An evaluation of high-dose vitamin D for rheumatoid arthritis. J Clin Rheumatol. 2014 Mar;20(2):112-4. doi: 10.1097/RHU.0000000000000072. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'This study recruits individuals with rheumatoid arthritis (RA) and low vitamin D concentrations. Subjects are dosed with vitamin D or placebo for one year. Primary outcome is change in bone turnover markers, additionally, bone mineral density and parameters of RA status are evaluated throughout the study.', 'detailedDescription': "Osteoporosis is twice as common in people with rheumatoid arthritis (RA), compared to age and gender-matched controls \\[1, 2\\]. Hypovitaminosis D can contribute to osteoporosis pathogenesis by decreasing calcium absorption, leading to a decline in serum ionized calcium, a rise in parathyroid hormone levels and upregulation of osteoclast activity, leading to loss of calcium from the skeleton. Hypovitaminosis D is also common in patients with rheumatoid arthritis \\[3-5\\], making it an appealing target to potentially improve health in both RA and osteoporosis.\n\nVitamin D has theoretic potential to modulate RA disease activity, based on the presence of vitamin D receptors in lymphocytes, macrophages, chondrocytes, and synovial cells \\[6\\]. Vitamin D, given as the bioactive metabolite 1,25(OH)2D, ameliorates disease activity in murine models of RA \\[7, 8\\]. However, few studies have evaluated the effect of vitamin D on RA disease activity in humans. Two three month open-label studies reported that vitamin D reduced RA disease activity \\[9\\] and pain levels \\[10\\]. By contrast, an eight-week open-label study \\[11\\] reported no reduction in swollen joint counts, inflammatory markers or cytokine levels after vitamin D therapy. The only double-blind, placebo-controlled trial published thus far \\[12\\] found no significant effect of vitamin D on RA disease activity, but was limited by the lack of hypovitaminosis D as a criterion for study entry. Indeed, at baseline subjects' mean 25(OH)D levels indicated vitamin D repletion, potentially explaining the null effect of vitamin D on RA disease activity.\n\nThree studies have evaluated the effect of vitamin D on bone mineral density (BMD) in patients with RA \\[13-15\\]. Researchers \\[14\\] randomized 96 subjects with RA to vitamin D (500 IU/day) and calcium (1000 mg/day) or placebo for two years; vitamin D and calcium therapy modestly increased BMD in the spine and hip. In another study \\[15\\], 20 subjects randomized to daily calcium and 1 α-hydroxyvitamin D for up to 24 months experienced similar declines in radius and spine BMD compared to 15 controls \\[15\\]. Likewise, vitamin D and calcium did not prevent bone loss in a prospective cohort study of patients with RA \\[13\\]. However, none of the studies required hypovitaminosis D as an entry criterion, vitamin D repletion to 25(OH)D levels \\> 32 ng/ml were not evaluated \\[13, 14\\] or achieved \\[15\\], and low doses of vitamin D were administered, potentially limiting skeletal benefits of this therapy.\n\nWe hypothesized that correction of hypovitaminosis D in subjects with RA would decrease parathyroid hormone (PTH), increase BMD, improve functional capacity and down-regulate inflammatory cytokine production, thereby diminishing disease activity. Vitamin D is inexpensive and widely available. If proven beneficial, vitamin D might become a mainstay of therapy for subjects with RA."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Rheumatology\n\nExclusion Criteria:\n\n* Bisphosphonate therapy'}, 'identificationModule': {'nctId': 'NCT00423358', 'briefTitle': 'Treatment of Hypovitaminosis D in Rheumatoid Arthritis', 'organization': {'class': 'OTHER', 'fullName': 'University of Wisconsin, Madison'}, 'officialTitle': 'Treatment of Hypovitaminosis D in Rheumatoid Arthritis', 'orgStudyIdInfo': {'id': '2004-0011'}, 'secondaryIdInfos': [{'id': 'K23AR050995', 'link': 'https://reporter.nih.gov/quickSearch/K23AR050995', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'vitamin D', 'description': 'ergocalciferol 50,000 IU Twice monthly', 'interventionNames': ['Dietary Supplement: Vitamin D']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'description': 'matching placebo tablet', 'interventionNames': ['Dietary Supplement: placebo']}], 'interventions': [{'name': 'Vitamin D', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['ergocalciferol'], 'description': 'Ergocalciferol 50,000 IU loading dose then twice monthly for one year', 'armGroupLabels': ['vitamin D']}, {'name': 'placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'matching placebo', 'armGroupLabels': ['placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '53705', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'University of Wisconsin', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}], 'overallOfficials': [{'name': 'Karen E Hansen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Wisconsin, Madison'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Wisconsin, Madison', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}