Effects of vitamin D3 in clinically isolated syndrome and healthy control participants: A double-blind randomised controlled trial

Karen O’Connell, Jamal Sulaimani, Sharee A. Basdeo, Katie Kinsella, Sinead Jordan, Orla Kenny, Siobhan B. Kelly, David Murphy, Eric Heffernan, Ronan P. Killeen, Keith Mulready, Marguerite MacMahon, Jennifer J. Brady, Carmel McKenna, Ciaran Muldowney, Lorraine Cassidy, Cathal Walsh, Killian O’Rourke, Niall Tubridy, Chris McGuiganJean M. Fletcher, Michael Hutchinson

Research output: Contribution to journalArticlepeer-review

Abstract

Background: Lowserum vitamin D levels are associated with susceptibility to, and severity of, multiple sclerosis. High dose vitamin D has been proposed as a potential immunomodulator in multiple sclerosis. Objectives: We performed a single centre, investigator-led, exploratory, double-blind, randomised, placebo controlled, trial of vitamin D3 in clinically isolated syndrome and healthy control participants to assess its immunological effects. Secondary end-points included clinical and magnetic resonance imaging outcomes and safety. Methods: Clinically isolated syndrome patients and healthy control participants were randomised to: placebo, 5000 IU or 10,000 IU vitamin D3/day (Vigantol oil). Study duration was 24 weeks. Results: The trial did not meet its primary end point, with no difference in the frequency of pro-inflammatory CD4+ T cells (interleukin (IL)-17+/interferon (IFN)-γ+) seen. A higher level of disease freedom (67% versus 50%) was seen in those with serum 1,25 (OH) vitamin D levels>100 nmol/l but this did not reach significance. High dose vitamin D3 was well tolerated with no safety signal. Conclusions: High dose vitamin D3 over 24 weeks was well tolerated but without immunological, magnetic resonance imaging or clinical evidence of benefit. The hypothesised therapeutic effects in clinically isolated syndrome or multiple sclerosis patients may require longer periods of administration or may only be seen in patients treated with vitamin D3 as an adjunct to established disease modifying therapies.

Original languageEnglish
Pages (from-to)2055217317727296
JournalMultiple Sclerosis Journal - Experimental, Translational and Clinical
Volume3
Issue number3
DOIs
Publication statusPublished - 1 Sep 2017

Keywords

  • cholecalciferol
  • clinically isolated syndrome
  • immunology
  • Multiple sclerosis
  • randomised controlled trial
  • vitamin D

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