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

Contemp Clin Trials. 2014 Nov;39(2):288-93. doi: 10.1016/j.cct.2014.10.004. Epub 2014 Oct 12.


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.

Keywords: Clinical trial; Double-blind; Multiple sclerosis; Randomized; Vitamin D.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Adult
  • Dietary Supplements*
  • Dose-Response Relationship, Drug
  • Double-Blind Method
  • Female
  • Glatiramer Acetate
  • Humans
  • Immunosuppressive Agents / therapeutic use
  • Magnetic Resonance Imaging
  • Male
  • Middle Aged
  • Multiple Sclerosis, Relapsing-Remitting / drug therapy*
  • Peptides / therapeutic use
  • Prospective Studies
  • Research Design*
  • United States
  • Vitamin D / administration & dosage
  • Vitamin D / adverse effects
  • Vitamin D / therapeutic use*
  • Young Adult


  • Immunosuppressive Agents
  • Peptides
  • Vitamin D
  • Glatiramer Acetate

Associated data