Cholecalciferol in relapsing-remitting MS: A randomized clinical trial (CHOLINE).

ABSTRACT: To evaluate the safety and efficacy of cholecalciferol in patients with relapsing-remitting MS (RRMS). In this double-blind, placebo-controlled parallel-group, 2-year study, 181 patients with RRMS were randomized 1:1. Key inclusion criteria were a low serum 25-hydroxy vitamin D (25OHD) concentration (<75 nmol/L), a treatment with interferon beta-1a 44 μg (SC 3 times per week) 4 months ± 2 months before randomization, and at least one documented relapse during the previous 2 years. Patients received high-dose oral cholecalciferol 100,000 IU or placebo every other week for 96 weeks. Primary outcome measure was the change in the annualized relapse rate (ARR) at 96 weeks. Secondary objectives included safety and tolerability of cholecalciferol and efficacy assessments (ARR, MRI parameters, and

SUBMITTER: Camu W 

PROVIDER: S-EPMC6705622 | biostudies-literature | 2019 Sep

REPOSITORIES: biostudies-literature