Journal
CONTEMPORARY CLINICAL TRIALS
Volume 39, Issue 2, Pages 288-293Publisher
ELSEVIER SCIENCE INC
DOI: 10.1016/j.cct.2014.10.004
Keywords
Vitamin D; Multiple sclerosis; Clinical trial; Randomized; Double-blind
Funding
- National Multiple Sclerosis Society [RG-4407A2/1, FP-1787A1]
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Background: Lower levels of vitamin D are associated with increased MS risk and with greater clinical and brain MRI activity in established relapsing MS. Objective: The VIDAMS trial (NCT01490502) is evaluating whether high-dose vitamin D supplementation reduces the risk of MS activity. Design/methods: Eligibility criteria include diagnosis of RRMS, age 18 to 50 years, and Expanded Disability Status Scale <= 4.0. Disease duration and activity requirements depend on whether 2005 or 2010 criteria are used for diagnosis. Enrollment is restricted based on prior MS therapy exposure and recent vitamin D use. After completing a one-month run-in of glatiramer acetate, 172 patients will be randomized 1:1 to oral vitamin D-3 5000 IU versus 600 IU daily. Clinical visits occur every 12 weeks for 96 weeks. Results: Sixteen sites throughout the United States are participating in the trial. Complete enrollment is expected by late 2014, with follow-up through 2016. No interim analyses are planned. The primary outcome for the trial is the proportion of patients experiencing a relapse in each group. Other clinical, patient-reported, and MRI outcomes will be evaluated. Conclusions: The VIDAMS trial will provide critical information about the safety and efficacy of vitamin D therapy in RRMS, with implications for MS patients worldwide. (C) 2014 Elsevier Inc. All rights reserved.
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