Safety Trial of High Dose Oral Vitamin D3 With Calcium in Multiple Sclerosis
NCT ID: NCT00644904
Last Updated: 2008-03-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
49 participants
INTERVENTIONAL
2006-07-31
2008-02-29
Brief Summary
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This 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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Treatment
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.
Vitamin D3
Control
Patients are allowed to supplement with up to 4,000 IU per day of Vitamin D3 if desired.
Vitamin D3
Interventions
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Vitamin D3
Vitamin D3
Eligibility Criteria
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Inclusion Criteria
* Age 18-55
* EDSS 0-6.5
Exclusion Criteria
* Current Vitamin D3 use \>4000 IU/d
* Baseline (25(OH)D) level \<20 mmol/L (frank deficiency) and \>150 mmol/L
* Pregnancy or inability/unwillingness to use contraception
* History of cardiac arrhythmia
* History of renal disease and nephrolithiasis
* History of granulomatous disease or lymphoma
* Relapse activity or steroid use in the past 60 days
18 Years
55 Years
ALL
Yes
Sponsors
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Direct MS-Proactive Charity
UNKNOWN
Multiple Sclerosis Society of Canada
OTHER
University of Toronto
OTHER
Responsible Party
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St. Michael's Hospital, Division of Neurology, University of Toronto
Principal Investigators
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Jodie M Burton, MD
Role: PRINCIPAL_INVESTIGATOR
St. Michael's Hospital, University of Toronto
Paul W O'Connor, MD, MSc
Role: PRINCIPAL_INVESTIGATOR
St. Michael's Hospital, University of Toronto
Locations
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St. Michael's Hospital
Toronto, Ontario, Canada
Countries
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References
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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.
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.
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.
Other Identifiers
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REB05-147
Identifier Type: -
Identifier Source: org_study_id