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.

Phase 3
NCT01490502
Neuroscience - Multiple Sclerosis, Neuroscience
Peiqing Qian, MD
Lauren Lennox
Inclusion Criteria:
  1. Must meet MAGNIMS criteria for relapsing-remitting MS
  2. Age 18 to 50 years
  3. MS disease duration ≤ 10 years if McDonald RRMS; ≤ 1 year if meets MAGNIMS RRMS criteria but not McDonald RRMS criteria
  4. Females of child-bearing age must be willing to use at least one form of pregnancy prevention throughout the study.
  5. 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.
Exclusion Criteria:
  1. Not be pregnant or nursing
  2. No ongoing renal or liver disease
  3. No known history of nephrolithiasis, hypercalcemia, sarcoidosis or other serious chronic illness including cancer (other than basal cell or squamous cell carcinoma of the skin), cardiac disease, or HIV.

Lauren Lennox
206-320-4355
206-215-3565