Safety and immunologic effects of high-vs low-dose cholecalciferol in multiple sclerosis

Elias S. Sotirchos, Pavan Bhargava, Christopher Eckstein, Keith Van Haren, Moira Baynes, Achilles Ntranos, Anne Gocke, Lawrence Steinman, Ellen M. Mowry, Peter A. Calabresi

Research output: Contribution to journalArticlepeer-review

Abstract

Objective: To study the safety profile and characterize the immunologic effects of high- vs low-dose cholecalciferol supplementation in patients with multiple sclerosis (MS). Methods: In this double-blind, single-center randomized pilot study, 40 patients with relapsing-remitting MS were randomized to receive 10,400 IU or 800 IU cholecalciferol daily for 6 months. Assessments were performed at baseline and 3 and 6 months. Results: Mean increase of 25-hydroxyvitamin D levels from baseline to final visit was larger in the high-dose group (34.9 ng/mL; 95% confidence interval [CI] 25.0-44.7 ng/mL) than in the low-dose group (6.9 ng/mL; 95% CI 1.0-13.7 ng/mL). Adverse events were minor and did not differ between the 2 groups. Two relapses occurred, one in each treatment arm. In the high-dose group, we found a reduction in the proportion of interleukin-17+ CD4+ T cells (p 0.016), CD161+ CD4+ T cells (p 0.03), and effector memory CD4+ T cells (p 0.021) with a concomitant increase in the proportion of central memory CD4+ T cells (p 0.018) and naive CD4+ T cells (p 0.04). These effects were not observed in the low-dose group. Conclusions: Cholecalciferol supplementation with 10,400 IU daily is safe and tolerable in patients with MS and exhibits in vivo pleiotropic immunomodulatory effects in MS, which include reduction of interleukin-17 production by CD4+ T cells and decreased proportion of effector memory CD4+ T cells with concomitant increase in central memory CD4+ T cells and naive CD4+ T cells. Classification of evidence: This study provides Class I evidence that cholecalciferol supplementation with 10,400 IU daily is safe and well-tolerated in patients with MS and exhibits in vivo pleiotropic immunomodulatory effects.

Original languageEnglish (US)
Pages (from-to)382-390
Number of pages9
JournalNeurology
Volume86
Issue number4
DOIs
StatePublished - Jan 26 2016

ASJC Scopus subject areas

  • Clinical Neurology

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