title: 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.
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.
  
  
  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.
authors.affiliation: Department of Neurology, Johns Hopkins University School of Medicine, Baltimore, MD, USA.
authors.forename: Pavan
authors.initials: P
authors.lastname: Bhargava
authors.affiliation: Department of Neurology, Johns Hopkins University School of Medicine, Baltimore, MD, USA.
authors.forename: Sandra
authors.initials: S
authors.lastname: Cassard
authors.affiliation: Department of Neurology, Johns Hopkins University School of Medicine, Baltimore, MD, USA.
authors.forename: Sonya U
authors.initials: SU
authors.lastname: Steele
authors.affiliation: Yale Multiple Sclerosis Center Department of Neurology, Yale University, CT, USA.
authors.forename: Christina
authors.initials: C
authors.lastname: Azevedo
authors.affiliation: Yale Multiple Sclerosis Center Department of Neurology, Yale University, CT, USA.
authors.forename: Daniel
authors.initials: D
authors.lastname: Pelletier
authors.affiliation: Department of Biostatistics, Johns Hopkins School of Public Health, Baltimore, MD, USA.
authors.forename: Elizabeth A
authors.initials: EA
authors.lastname: Sugar
authors.affiliation: Department of Neurology, University of California San Francisco, San Francisco, CA, USA.
authors.forename: Emmanuelle
authors.initials: E
authors.lastname: Waubant
authors.affiliation: Department of Neurology, Johns Hopkins University School of Medicine, Baltimore, MD, USA. Electronic address: emowry1@jhmi.edu.
authors.forename: Ellen M
authors.initials: EM
authors.lastname: Mowry
mesh_terms: D000293:Adolescent; D000328:Adult; D019587:Dietary Supplements; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D000068717:Glatiramer Acetate; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use; D008279:Magnetic Resonance Imaging; D008297:Male; D008875:Middle Aged; D020529:Multiple Sclerosis, Relapsing-Remitting / Q000188:drug therapy*; D010455:Peptides / Q000627:therapeutic use; D011446:Prospective Studies; D012107:Research Design; D014481:United States; D014807:Vitamin D / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D055815:Young Adult
chemical_list: D007166:Immunosuppressive Agents; D010455:Peptides; D014807:Vitamin D; D000068717:Glatiramer Acetate
keywords: Clinical trial; Double-blind; Multiple sclerosis; Randomized; Vitamin D