Ignite Creation Date:
2025-12-24 @ 8:03 PM
Ignite Modification Date:
2026-03-11 @ 10:29 PM
Study NCT ID:
NCT00644904
Status:
COMPLETED
Last Update Posted:
2008-03-28
First Post:
2008-03-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety Trial of High Dose Oral Vitamin D3 With Calcium in Multiple Sclerosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009103', 'term': 'Multiple Sclerosis'}], 'ancestors': [{'id': 'D020278', 'term': 'Demyelinating Autoimmune Diseases, CNS'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D003711', 'term': 'Demyelinating Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System 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': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 49}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-03', 'completionDateStruct': {'date': '2008-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-03-27', 'studyFirstSubmitDate': '2008-03-24', 'studyFirstSubmitQcDate': '2008-03-26', 'lastUpdatePostDateStruct': {'date': '2008-03-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-03-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Serum calcium', 'timeFrame': 'at each dose change'}], 'secondaryOutcomes': [{'measure': 'Serum 25(OH)D', 'timeFrame': 'at each dose change'}, {'measure': 'EDSS', 'timeFrame': 'at screening vs. end of trial'}, {'measure': 'N-telopeptide (bone marker)'}, {'measure': 'ALP/AST/ALT', 'timeFrame': 'at each dose change'}, {'measure': 'Creatinine/urea', 'timeFrame': 'at each dose change'}, {'measure': 'EKG', 'timeFrame': 'at screening and end of trial'}, {'measure': 'Renal ultrasound', 'timeFrame': 'at screening, mid-trial and end of trial'}, {'measure': 'Cytokine profile/MMP/lymphocyte response assay'}, {'measure': 'Annualized relapse rate', 'timeFrame': 'year prior to trial versus year of trial'}, {'measure': 'PTH', 'timeFrame': 'at each dose change'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Multiple Sclerosis', 'Vitamin D', 'Safety'], 'conditions': ['Multiple Sclerosis']}, 'referencesModule': {'references': [{'pmid': '17823429', 'type': 'BACKGROUND', 'citation': "Kimball SM, Ursell MR, O'Connor P, Vieth R. Safety of vitamin D3 in adults with multiple sclerosis. Am J Clin Nutr. 2007 Sep;86(3):645-51. doi: 10.1093/ajcn/86.3.645."}, {'pmid': '21697250', 'type': 'DERIVED', 'citation': "Kimball S, Vieth R, Dosch HM, Bar-Or A, Cheung R, Gagne D, O'Connor P, D'Souza C, Ursell M, Burton JM. Cholecalciferol plus calcium suppresses abnormal PBMC reactivity in patients with multiple sclerosis. J Clin Endocrinol Metab. 2011 Sep;96(9):2826-34. doi: 10.1210/jc.2011-0325. Epub 2011 Jun 22."}, {'pmid': '21570386', 'type': 'DERIVED', 'citation': "Kimball SM, Burton JM, O'Connor PG, Vieth R. Urinary calcium response to high dose vitamin D3 with calcium supplementation in patients with multiple sclerosis. Clin Biochem. 2011 Jul;44(10-11):930-2. doi: 10.1016/j.clinbiochem.2011.04.017. Epub 2011 May 5."}]}, 'descriptionModule': {'briefSummary': 'Vitamin D likely plays a role in the geography of Multiple Sclerosis (MS), and patients at risk and with MS have relatively low Vitamin D levels compared to their normal counterparts.\n\nThis trial examines the safety of high dose oral Vitamin D3 titrated up to a maximum of 40,000 IU per day over a 12 month period. Fifty patients matched for MS and non-MS characteristics will be divided into two groups: one group receiving the high dose Vitamin D regimen, and the other restricted to a maximum of 4000 IU per day. The hypothesis is that patients with MS can tolerate seemingly high doses of Vitamin D3 without adverse events and/or calcium-related abnormalities. It is also hypothesized that those receiving the higher doses will demonstrate improved relapse and disability status compared to controls, and that the treatment group will show improved markers of bone health and immune indicators of reduced inflammation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinically definite MS\n* Age 18-55\n* EDSS 0-6.5\n\nExclusion Criteria:\n\n* EDSS =\\> 7.0\n* Current Vitamin D3 use \\>4000 IU/d\n* Baseline (25(OH)D) level \\<20 mmol/L (frank deficiency) and \\>150 mmol/L\n* Pregnancy or inability/unwillingness to use contraception\n* History of cardiac arrhythmia\n* History of renal disease and nephrolithiasis\n* History of granulomatous disease or lymphoma\n* Relapse activity or steroid use in the past 60 days'}, 'identificationModule': {'nctId': 'NCT00644904', 'acronym': 'VitD4MS', 'briefTitle': 'Safety Trial of High Dose Oral Vitamin D3 With Calcium in Multiple Sclerosis', 'organization': {'class': 'OTHER', 'fullName': 'University of Toronto'}, 'officialTitle': 'A Phase I/II Dose-Escalation Trial of Vitamin D3 With Calcium Supplementation in Patients With Multiple Sclerosis', 'orgStudyIdInfo': {'id': 'REB05-147'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment', 'description': 'Starting dose of 4,000 IU per day of Vitamin D3 titrating up to a dose of 40,000 IU per day of Vitamin D3 by month six. In the second six-month part of the trial, patients titrate back down to 4,000 IU per day of Vitamin D3 and then discontinue it completely at the end of the 12 month trial period.', 'interventionNames': ['Dietary Supplement: Vitamin D3']}, {'type': 'OTHER', 'label': 'Control', 'description': 'Patients are allowed to supplement with up to 4,000 IU per day of Vitamin D3 if desired.', 'interventionNames': ['Dietary Supplement: Vitamin D3']}], 'interventions': [{'name': 'Vitamin D3', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Treatment']}, {'name': 'Vitamin D3', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M5B 1W8', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': "St. Michael's Hospital", 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Jodie M Burton, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "St. Michael's Hospital, University of Toronto"}, {'name': "Paul W O'Connor, MD, MSc", 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "St. Michael's Hospital, University of Toronto"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Toronto', 'class': 'OTHER'}, 'collaborators': [{'name': 'Direct MS-Proactive Charity', 'class': 'UNKNOWN'}, {'name': 'Multiple Sclerosis Society of Canada', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': "Dr. Paul O'Connor", 'oldOrganization': "St. Michael's Hospital, Division of Neurology, University of Toronto"}}}}