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

Area of Science:

• Neurology
• Endocrinology
• Immunology

Background:

• Multiple Sclerosis (MS) is a chronic autoimmune disease affecting the central nervous system.
• Vitamin D deficiency is common in MS patients and may influence disease activity.
• Interferon beta-1a is a standard treatment for relapsing-remitting MS (RRMS).

Purpose of the Study:

• To assess the safety and efficacy of high-dose cholecalciferol (vitamin D3) supplementation in patients with RRMS.
• To determine if cholecalciferol impacts the annualized relapse rate (ARR) in RRMS patients already on interferon beta-1a therapy.

Main Methods:

• A 2-year, double-blind, placebo-controlled study involving 181 RRMS patients with low serum 25-hydroxy vitamin D (25OHD).
• Patients received either high-dose oral cholecalciferol (100,000 IU) or placebo every other week.
• Outcomes included changes in ARR, MRI parameters, and Expanded Disability Status Scale (EDSS).

Main Results:

• The primary endpoint (significant reduction in ARR) was not met.
• However, cholecalciferol treatment favored efficacy parameters, including reduced ARR (p=0.012), fewer new T1 lesions (p=0.025), lower T1 lesion volume (p=0.031), and less EDSS progression (p=0.026).
• Adverse event rates were comparable between the cholecalciferol and placebo groups.

Conclusions:

• While not meeting the primary endpoint, cholecalciferol demonstrated a potential treatment effect in RRMS patients with low vitamin D levels receiving interferon beta-1a.
• The favorable safety profile supports further investigation of cholecalciferol as an adjunctive therapy in this patient population.