TY - JOUR
T1 - 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
AU - Smolders, Joost
AU - Hupperts, Raymond
AU - Barkhof, Frederik
AU - Grimaldi, Luigi M. E.
AU - Holmoy, Trygve
AU - Killestein, Joep
AU - Rieckmann, Peter
AU - Schluep, Myriam
AU - Vieth, Reinhold
AU - Hostalek, Ulrike
AU - Ghazi-Visser, Lizette
AU - Beelke, Manolo
PY - 2011/12/15
Y1 - 2011/12/15
N2 - 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.
AB - 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.
KW - Multiple sclerosis
KW - Vitamin D
KW - Interferon beta-1a
KW - 25-Hydroxyvitamin D
KW - 1,25-Dihydroxyvitamin D
KW - Clinical trial
KW - Biomarker
KW - SOLAR
U2 - 10.1016/j.jns.2011.04.013
DO - 10.1016/j.jns.2011.04.013
M3 - Article
C2 - 21620416
SN - 0022-510X
VL - 311
SP - 44
EP - 49
JO - Journal of the Neurological Sciences
JF - Journal of the Neurological Sciences
IS - 1-2
ER -