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High-dose vitamin D significantly reduced disease activity in patients with clinically isolated syndrome typical for multiple sclerosis (MS) and early relapsing-remitting MS, according to a study published in JAMA.

A known MS risk factor, vitamin D deficiency has also been linked with disease activity in patients with MS. Researchers investigated the benefits of vitamin D supplementation in a double-blind, randomized placebo-controlled trial called D-Lay MS.

D-Lay MS included 316 untreated patients with clinically isolated syndrome for less than 90 days, serum vitamin D concentration of less than 100 nmol/L, and magnetic resonance imaging (MRI) showing dissemination in space per 2010 criteria or two or more lesions and the presence of oligoclonal bands. The trial randomly assigned 163 patients to oral cholecalciferol 100,000 IU and 153 patients to placebo every 2 weeks over 24 months.

Disease & MRI Activity Declines With Vitamin D

In the primary analysis of 303 patients who received at least one dose, disease activity, defined as a relapse or new or contrast-enhancing, over 24 months occurred in 60.3% of patients who received vitamin D compared with 74.1% who received placebo. Researchers reported a hazard ratio of 0.66 for disease activity in the vitamin D group.

According to the study results, the median time to disease activity was 432 days in the vitamin D group compared with 224 days in the placebo group.

The vitamin D group had less frequent MRI activity (57.1% vs 65.3% in the placebo group, for a 0.71 hazard ratio), new lesions (46.2% vs 59.2%, 0.61 hazard ratio), and contrast-enhancing lesions (18.6% vs 34.0%, 0.47 hazard ratio) throughout the 24-month trial. Relapse occurred in 17.9% of patients in the vitamin D group compared with 21.8% in the placebo group.

Results were similar in a subgroup analysis of 247 patients meeting criteria for relapsing-remitting MS at baseline, researchers reported.

“Oral cholecalciferol 100,000 IU every 2 weeks significantly reduced disease activity in CIS and early relapsing-remitting MS,” the researchers wrote. “These results warrant further investigation, including the potential role of pulse high-dose vitamin D as add-on therapy.”