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

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.

Author information

1
Department of Neurology, Johns Hopkins University School of Medicine, Baltimore, MD, USA.
2
Yale Multiple Sclerosis Center Department of Neurology, Yale University, CT, USA.
3
Department of Biostatistics, Johns Hopkins School of Public Health, Baltimore, MD, USA.
4
Department of Neurology, University of California San Francisco, San Francisco, CA, USA.
5
Department of Neurology, Johns Hopkins University School of Medicine, Baltimore, MD, USA. Electronic address: emowry1@jhmi.edu.

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 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

PMID:
25311447
DOI:
10.1016/j.cct.2014.10.004
[Indexed for MEDLINE]

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