Efficacy of Cholecalciferol (Vitamin D3) for Delaying the Diagnosis of MS After a Clinically Isolated Syndrome

Phase 3 Completed 316 enrolled Nîmes University Hospital

RandomizedParallel-groupTriple-blindPrevention

Summary

The main objective of this study is to evaluate the efficacy and tolerance of 2 years of treatment with cholecalciferol (vitamin D3) in patients with a clinically isolated syndrome at high risk for MS (CIS).

Timeline

Start: 2013-07-16
Primary completion: 2023-01-04
Completion: 2023-01-04

Outcome

Met primary endpoint

paper Oral cholecalciferol 100 000 IU every 2 weeks significantly reduced disease activity in CIS and early relapsing-remitting MS. PMID 40063041 ↗

paper Disease activity was observed in 94 patients (60.3%) in the vitamin D group and 109 patients (74.1%) in the placebo group (hazard ratio (HR), 0.66 [95% CI, 0.50-0.87]; P = .004) PMID 40063041 ↗

Publications

Thouvenot E, Laplaud D, Lebrun-Frenay C, Derache N, Le Page E, Maillart E, Froment-Tilikete C, Castelnovo G, Casez O, Coustans M, Guennoc AM, Heinzlef O, Magy L, Nifle C, Ayrignac X, Fromont A, Gaillard N, Caucheteux N, Patry I, De Seze J, Deschamps R, Clavelou P, Biotti D, Edan G, Camu W, Agherbi H, Renard D, Demattei C, Fabbro-Peray P, Mura T, Rival M; D-Lay MS Investigators. High-Dose Vitamin D in Clinically Isolated Syndrome Typical of Multiple Sclerosis: The D-Lay MS Randomized Clinical Trial. JAMA. 2025 Apr 22;333(16):1413-1422. doi: 10.1001/jama.2025.1604.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Cholecalciferol	Other / unclassified	100000 iu	Oral