Randomized trial of daily high-dose vitamin D in patients with RRMS receiving subcutaneous interferon β-1a.

Objective: In the phase II, randomized, double-blind, placebo-controlled Supplementation of Vigantol Oil versus Placebo Add-on in Patients with Relapsing-Remitting Multiple Sclerosis (RRMS) Receiving Rebif Treatment (SOLAR) study (NCT01285401), we assessed the efficacy and safety of add-on vitamin D in patients with RRMS.

Methods: Eligible patients with RRMS treated with SC interferon-β-1a (IFN-β-1a) 44 μg 3 times weekly and serum 25(OH)D levels <150 nmol/L were included. From February 15, 2011, to May 11, 2015, 229 patients were included and randomized 1:1 to receive SC IFN-β-1a plus placebo (n = 116) or SC IFN-β-1a plus oral high-dose vitamin D 14,007 IU/d (n = 113).

Prognostic biomarkers of IFNb therapy in multiple sclerosis patients.

Background: Interferon beta (IFNb) reduces relapse frequency and disability progression in patients with multiple sclerosis (MS).

Objectives: Early identification of prognostic biomarkers of IFNb-treated patients will allow more effective management of MS.

Methods: The IMPROVE study evaluated subcutaneous IFNb versus placebo in 180 patients with relapsing-remitting MS.

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.

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.