High-Dose Vitamin D Eases Disease Activity in Patients With Multiple Sclerosis
High-dose vitamin D reduced disease activity over 24 months in patients with clinically isolated syndrome typical for multiple sclerosis (MS) and early relapsing-remitting MS, according to study results published in JAMA.
“Vitamin D deficiency is a risk factor for MS and is associated with the risk of disease activity, but data on the benefits of supplementation are conflicting,” explained first author Eric Thouvenot, MD, PhD, of the Université Montpellier, Nimes, France, and coauthors in the study background.
To further investigate the effect of vitamin D supplementation, 36 MS centers in France conducted a double-blind, randomized placebo-controlled trial called D-Lay MS. The study included 316 untreated patients with clinically isolated syndrome of less than 90 days’ duration, serum vitamin D concentration less than 100 nmol/L, and diagnostic magnetic resonance imaging (MRI) that met 2010 criteria for dissemination in space or 2 or more lesions and presence of oligoclonal bands. Among the patients, 163 were randomized to oral cholecalciferol 100 000 IU and 153 to placebo every 2 weeks for 24 months.
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The primary analysis included 303 patients with at least 1 dose of the study drug.
Disease activity, which was defined as a relapse or MRI activity (new or contrast-enhancing lesions) over 24 months, occurred in 60.3% of patients in the vitamin D group and 74.1% of patients in the placebo group, for a 0.66 hazard ratio, according to the study. The median time to disease activity was almost twice as long in the vitamin D group compared with the placebo group (432 vs 224 days).
Specifically, MRI activity occurred in 57.1% of patients in the vitamin D group compared with 65.3% in the placebo group, for a 0.71 hazard ratio. New lesions affected 46.2% of patients in the vitamin D group compared with 59.2% of patients in the placebo group, for a 0.61 hazard ratio. Contrast-enhancing lesions occurred in 18.6% of patients in the vitamin D group compared with 34.0% in the placebo group, for a 0.47 hazard ratio.
The study identified no significant differences between groups for 10 secondary clinical outcomes, including relapse, which affected 17.9% in the vitamin D group and 21.8% in the placebo group, for a 0.69 hazard ratio.
In a subset of 247 patients meeting criteria for relapsing-remitting MS at treatment initiation, results were similar, researchers reported.
“These results warrant further investigation,” investigators wrote, “including the potential role of pulse high-dose vitamin D as add-on therapy.”
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