Randomized trial of daily high-dose vitamin D3 in patients with RRMS receiving subcutaneous interferon β-1a

Raymond Hupperts*, Joost Smolders, Reinhold Vieth, Trygve Holmoy, Kurt Marhardt, Myriam Schluep, Joep Killestein, Frederik Barkhof, Manolo Beelke, Luigi M. E. Grimaldi, SOLAR Study Group

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review

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Abstract

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-3 in patients with RRMS.

Methods

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

Results

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).

Conclusions

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.

Original languageEnglish
Pages (from-to)E1906-E1916
Number of pages11
JournalNeurology
Volume93
Issue number20
DOIs
Publication statusPublished - 12 Nov 2019

Keywords

  • MULTIPLE-SCLEROSIS ACTIVITY
  • DOUBLE-BLIND
  • 25-HYDROXYVITAMIN D
  • SUPPLEMENTATION
  • MULTICENTER
  • CALCIUM
  • SAFETY
  • RISK
  • CHOLECALCIFEROL
  • PROGRESSION

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