Efficacy of vitamin D(3) as add-on therapy in patients with relapsing-remitting multiple sclerosis receiving subcutaneous interferon beta-1a: A Phase II, multicenter, double-blind, randomized, placebo-controlled trial.
Author(s): Smolders J, Hupperts R, Barkhof F, Grimaldi LM, Holmoy T, Killestein J, Rieckmann P, Schluep M, Vieth R, Hostalek U, Ghazi-Visser L, Beelke M
Affiliation(s): Maastricht University Medical Centre, Maastricht, The Netherlands.
Publication date & source: 2011-12-15, J Neurol Sci., 311(1-2):44-49. Epub 2011 May 28.
Recent studies have demonstrated the immunomodulatory properties of vitamin D, and vitamin D deficiency may be a risk factor for the development of MS. The risk of developing MS has, in fact, been associated with rising latitudes, past exposure to sun and serum vitamin D status. Serum 25-hydroxyvitamin D [25(OH)D] levels have also been associated with relapses and disability progression. The identification of risk factors, such as vitamin D deficiency, in MS may provide an opportunity to improve current treatment strategies, through combination therapy with established MS treatments. Accordingly, vitamin D may play a role in MS therapy. Small clinical studies of vitamin D supplementation in patients with MS have reported positive immunomodulatory effects, reduced relapse rates and a reduction in the number of gadolinium-enhancing lesions. However, large randomized clinical trials of vitamin D supplementation in patients with MS are lacking. SOLAR (Supplementation of VigantOL((R)) oil versus placebo as Add-on in patients with relapsing-remitting multiple sclerosis receiving Rebif((R)) treatment) is a 96-week, three-arm, multicenter, double-blind, randomized, placebo-controlled, Phase II trial (NCT01285401). SOLAR will evaluate the efficacy of vitamin D(3) as add-on therapy to subcutaneous interferon beta-1a in patients with RRMS. Recruitment began in February 2011 and is aimed to take place over 1 calendar year due to the potential influence of seasonal differences in 25(OH)D levels. Copyright (c) 2011 Elsevier B.V. All rights reserved.