Effects of Adjunct Low-Dose Vitamin D on Relapsing-Remitting Multiple Sclerosis Progression: Preliminary Findings of a Randomized Placebo-Controlled Trial

Abstract

The aim of this preliminary study was to evaluate the effect of low-dose oral vitamin D in combination with current disease-modifying therapy on the prevention of progression of relapsing-remitting multiple sclerosis (RRMS). A phase II double-blind placebo-controlled randomized clinical trial conducted between October 2007 and October 2008 included 50 patients with confirmed RRMS aged 25 to 57 years and normal serum 25-hydroxyvitamin D. They were randomly allocated to receive 12 months of treatment with either escalating calcitriol doses up to 0.5 μg/day or placebo combined with disease-modifying therapy. Response to treatment was assessed at eight-week intervals. In both groups, the mean relapse rate decreased significantly (P < 0.001). In the 25 patients treated with placebo, the mean (SD) Expanded Disability Status Scale (EDSS) increased from 1.70 (1.21) at baseline to 1.94 (1.41) at the end of study period (P < 0.01). Average EDSS and relapse rate at the end of trial did not differ between groups. Adding low-dose vitamin D to routine disease-modifying therapy had no significant effect on the EDSS score or relapse rate. A larger phase III multicenter study of vitamin D in RRMS is warranted to more assess the efficacy of this intervention.

Can we prevent or treat multiple sclerosis by individualised vitamin D supply?

“…The capacity of low dose calcitriol to prevent disease progression in relapsing remitting multiple sclerosis (RRMS) when given in adjunction to undefined disease-modifying treatment strategies was investigated in a randomised and double blind but rather small study on 50 patients. After 12 months, no significant differences between verum and placebo arms were observed with respect to relapse rate and disability [118]. Two recently published studies from Finland and Norway, both applying 20,000 IU/week in a randomised, double blind and placebo-controlled design (evidence level Ib), yielded partly contradictory results with respect to clinical and MRI parameters.…”

A Systematic Review of Randomized, Double-Blind, Placebo-Controlled Trials Examining the Clinical Efficacy of Vitamin D in Multiple Sclerosis

“…[28–33] (Figure 1) However, the study by Aivo et al[33] was a sub-study of another main trial. [31] Of the five trials included, four gained the maximum score;[29–32] one study scored two points (the authors did not mentioned randomization and blinding procedures, as well as the reasons for patient withdrawals and dropouts for each treatment group). [28] The randomization procedure was reported in sufficient detail to be sure that it was appropriate in four studies.…”

“…[28] The randomization procedure was reported in sufficient detail to be sure that it was appropriate in four studies. [29–32] In one study, the randomization procedure was not reported. [28] Likewise, double blinding method was appropriately explained in four studies;[29–32] in one study was nor reported.…”

Vitamin D in multiple sclerosis: implications for assessment and treatment

“…A 6-month randomized clinical trial of 300,000 IU vitamin D3 per month, comprising 62 patients treated with IFN-β 1a , did not find any effect on EDSS or gadolinium-enhancing MRI lesions, but an increase in the expression of IL-10 and TGF-β and a reduction in T-cell proliferation [104]. Another-12 month study of 50 RRMS patients, all on immunomodulatory treatment, did not show any effect on relapse rate or EDSS development of escalating doses of calcitriol up to 0.5 mg per day compared with placebo [105]. After adjustment for baseline EDSS, Stein et al reported marginally higher EDSS in 11 patients who had received high-dose (6000 IU) compared with 12 patients who had received low-dose (1000 U) vitamin D 2 , whereas no differences were recorded in the primary MRI end points [13].…”