Bhargava P, Cassard S, Steele SU, Azevedo C, Pelletier D, Sugar EA, Waubant E, Mowry EM. 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 Oct. pii: S1551-7144(14)00150-5.
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) evaluates 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 5,000IU 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
So paper for old rope. You write up the trial before you get any data......Mint.
So we have mega dose verses supermarket multi-vitamin dose. Wonder what ProfG makes of this? This is a multi centre trial with 15 sites in USA taking Vitamin D and copaxone. I wonder how natural sunlight exposure will influence this I guess people in North with get low and high dose and people in south will get low and high doses I guess it adds "noise" into the system.
Labels: Vitamin D