The Vitamin D to Ameliorate Multiple Sclerosis (VIDAMS) trial: Study design for a multicenter, randomized, double-blind controlled trial of vitamin D in multiple sclerosis

Pavan Bhargava, Sandra Cassard, Sonya U. Steele, Christina Azevedo, Daniel Pelletier, Elizabeth A. Sugar, Emmanuelle Waubant, Ellen M. Mowry

Research output: Contribution to journalArticlepeer-review

Abstract

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 50years, 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 D3 5000IU versus 600IU daily. Clinical visits occur every 12weeks for 96weeks. 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.

Original languageEnglish (US)
Pages (from-to)288-293
Number of pages6
JournalContemporary Clinical Trials
Volume39
Issue number2
DOIs
StatePublished - Nov 1 2014

Keywords

  • Clinical trial
  • Double-blind
  • Multiple sclerosis
  • Randomized
  • Vitamin D

ASJC Scopus subject areas

  • Pharmacology (medical)

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