title: 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.
abstract: 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.
authors.affiliation: Maastricht University Medical Centre, Maastricht, The Netherlands. smolders@gmail.com
authors.forename: Joost
authors.initials: J
authors.lastname: Smolders
authors.forename: Raymond
authors.initials: R
authors.lastname: Hupperts
authors.forename: Frederik
authors.initials: F
authors.lastname: Barkhof
authors.forename: Luigi M E
authors.initials: LM
authors.lastname: Grimaldi
authors.forename: Trygve
authors.initials: T
authors.lastname: Holmoy
authors.forename: Joep
authors.initials: J
authors.lastname: Killestein
authors.forename: Peter
authors.initials: P
authors.lastname: Rieckmann
authors.forename: Myriam
authors.initials: M
authors.lastname: Schluep
authors.forename: Reinhold
authors.initials: R
authors.lastname: Vieth
authors.forename: Ulrike
authors.initials: U
authors.lastname: Hostalek
authors.forename: Lizette
authors.initials: L
authors.lastname: Ghazi-Visser
authors.forename: Manolo
authors.initials: M
authors.lastname: Beelke
mesh_terms: D000293:Adolescent; D000328:Adult; D002762:Cholecalciferol / Q000008:administration & dosage* / Q000627:therapeutic use; D019587:Dietary Supplements / Q000592:standards; D004311:Double-Blind Method; D004357:Drug Synergism; D005260:Female; D006801:Humans; D000068556:Interferon beta-1a; D016899:Interferon-beta / Q000008:administration & dosage* / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D020529:Multiple Sclerosis, Relapsing-Remitting / Q000188:drug therapy* / Q000276:immunology / Q000378:metabolism; D014808:Vitamin D Deficiency / Q000175:diagnosis / Q000188:drug therapy; D055815:Young Adult
chemical_list: D002762:Cholecalciferol; D016899:Interferon-beta; D000068556:Interferon beta-1a