Article: article from journal or magazin.
Efficacy of vitamin D3 as add-on therapy in patients with relapsing-remitting multiple sclerosis receiving subcutaneous interferon β-1a: a Phase II, multicenter, double-blind, randomized, placebo-controlled trial.
Journal of the Neurological Sciences
SOLAR study group
Publication types: Clinical Trial, Phase II ; Journal Article ; Multicenter Study ; Randomized Controlled TrialPublication Status: ppublish
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(®) oil versus placebo as Add-on in patients with relapsing-remitting multiple sclerosis receiving Rebif(®) 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.
Adolescent, Adult, Cholecalciferol/administration & dosage, Cholecalciferol/therapeutic use, Dietary Supplements/standards, Double-Blind Method, Drug Synergism, Female, Humans, Interferon-beta/administration & dosage, Interferon-beta/therapeutic use, Male, Middle Aged, Multiple Sclerosis, Relapsing-Remitting/drug therapy, Multiple Sclerosis, Relapsing-Remitting/immunology, Vitamin D Deficiency/diagnosis, Vitamin D Deficiency/drug therapy, Young Adult
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