Low vitamin D levels have been shown to increase a person's risk of developing multiple
sclerosis (MS), and patients with MS who have lower vitamin D levels are at increased risk of
having attacks. However, it is not known if giving supplemental vitamin D to those with MS
reduces the risk of attacks, and some research suggests that vitamin D could even be harmful
to people with MS.
In this clinical trial, patients with relapsing-remitting MS will receive high-dose or
low-dose oral vitamin D in addition to an approved therapy for MS, glatiramer acetate.
Patients will be evaluated for two years, and the effect of high-dose vitamin D
supplementation on the rate of MS attacks and on the number of new lesions and change in
brain volume on MRI will be determined. Establishing this association will have major
implications for the treatment of individuals with MS throughout the world.
Phase:
Phase 3
Details
Lead Sponsor:
Johns Hopkins University
Collaborators:
Anne Arundel Health System Research Institute Columbia University Dignity Health Icahn School of Medicine at Mount Sinai Oregon Health and Science University Stanford University Swedish Medical Center The Cleveland Clinic University of California, San Francisco University of Massachusetts, Worcester University of Pennsylvania University of Rochester University of Virginia Washington University School of Medicine Yale University
Treatments:
Cholecalciferol Ergocalciferols Vitamin D Vitamins