Safety and immunologic effects of high- vs low-dose cholecalciferol in multiple sclerosis. (26th January 2016)

• Record Type: Journal Article
• Authors: Sotirchos, Elias S.; Bhargava, Pavan; Eckstein, Christopher; Van Haren, Keith; Baynes, Moira; Ntranos, Achilles; Gocke, Anne; Steinman, Lawrence; Mowry, Ellen M.; Calabresi, Peter A.
• Is Part Of: Neurology. Volume 86:Number 4(2016)
• Publication Date: 2016-01-26
• Subjects: Neurology -- Periodicals; Neurology -- Periodicals; Neurologie -- Périodiques; 616.8
• DOI: 10.1212/WNL.0000000000002316
• Languages: English
• ISSNs: 0028-3878

Abstract

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.