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-3 in patients with RRMS.
Eligible patients with RRMS treated with SC interferon-beta-1a (IFN-beta-1a) 44 mu g 3 times weekly and serum 25(OH)D levels
At 48 weeks, 36.3% of patients who received high-dose vitamin D-3 had NEDA-3, without a statistically significant difference in NEDA-3 status between groups (placebo 35.3%; odds ratio 0.93; 95% confidence interval [CI] 0.53-1.63; p = 0.80). Compared with placebo, the high-dose vitamin D-3 group had better MRI outcomes for combined unique active lesions (incidence rate ratio 0.68; 95% CI 0.52-0.89; p = 0.0045) and change from baseline in total volume of T2 lesions (difference in mean ranks: -0.074; p = 0.035).
SOLAR did not establish a benefit for high-dose vitamin D-3 as add-on to IFN-beta-1a, based on the primary outcome of NEDA-3, but findings from exploratory outcomes suggest protective effects on development of new MRI lesions in patients with RRMS.
Classification of evidence
This study provides Class II evidence that for patients with RRMS treated with SC IFN-beta-1a, 48 weeks of cholecalciferol supplementation did not promote NEDA-3 status.
- MULTIPLE-SCLEROSIS ACTIVITY
- 25-HYDROXYVITAMIN D