A Randomized Controlled Trial of Vitamin D Supplementation in Multiple Sclerosis
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.
Stanford is now accepting new patients for this trial.
- drug : Vitamin D3
Phase: Phase 3
Ages Eligible For Study:
1. Must meet MAGNIMS criteria for relapsing-remitting MS 2. Age 18 to 50 years 3. EDSS score ? 4.0 4. MS disease duration ? 10 years if McDonald RRMS; ? 1 year if meets MAGNIMS RRMS criteria but not McDonald RRMS criteria 5. If the patient meets the McDonald RRMS criteria (rather than McDonald CIS that is now classified as MAGNIMS MS): - Must have had one clinical attack in past two years AND at least one new silent T2 or gadolinium-enhancing lesion on brain MRI within the past year OR - Must have had two clinical attacks in past two years, one of which occurred in the past year 6. Females of child-bearing age must be willing to use at least one form of pregnancy prevention throughout the study. 7. Must have had a 25-hydroxyvitamin D level of ? 15 ng/mL within past 30 days 8. Must be willing to stop taking additional supplemental vitamin D, except as part of a multivitamin, and must be willing to not take cod liver oil.