Vitamin D Supplementation in Multiple Sclerosis
This is a Phase 3 study lasting 2 years. This study provides COPAXONE Free-of-charge.
Low vitamin D levels have been shown to increase a person’s risk of developing 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. Patients with relapsing-remitting MS will be randomized to receive either high-dose or low-dose oral vitamin D in addition to an approved therapy for MS, glatiramer acetate (Copaxone™). The patient must not have had more than 3 months of prior exposure to Copaxone™. www.clinicaltrials.gov : Study NCT01490502
The main INCLUSION Criteria are 1) age18- 50 years; 2) Relapsing-remitting MS either gender; 3) Walking without need of assistance; 4) Must have had at least one clinical attack in past 2 years AND at least one new lesion on brain MRI within the past year OR must have had 2 clinical attacks in past 2 years, one of which occurred in past year.
Some EXCLUSIONS are: 1)Prior treatment with rituximab, any chemotherapeutic agent. 2) treatment in past 6 months with natalizumab (Tysabri™), fingolimod (Gilenya™)or dimethyl fumarate (Tecfidera™).
If already taking either glatiramer acetate or a beta interferon, the patient must be willing to stop taking it for ONE month prior to screening. There are several medications that are exclusionary as well.