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

Publication ,  Journal Article
Sotirchos, ES; Bhargava, P; Eckstein, C; Van Haren, K; Baynes, M; Ntranos, A; Gocke, A; Steinman, L; Mowry, EM; Calabresi, PA
Published in: Neurology
January 26, 2016

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.

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Published In

Neurology

DOI

EISSN

1526-632X

Publication Date

January 26, 2016

Volume

86

Issue

4

Start / End Page

382 / 390

Location

United States

Related Subject Headings

  • Vitamin D
  • Treatment Outcome
  • Pilot Projects
  • Neurology & Neurosurgery
  • Multiple Sclerosis, Relapsing-Remitting
  • Middle Aged
  • Male
  • Interleukin-17
  • Immunologic Factors
  • Humans
 

Citation

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Sotirchos, E. S., Bhargava, P., Eckstein, C., Van Haren, K., Baynes, M., Ntranos, A., … Calabresi, P. A. (2016). Safety and immunologic effects of high- vs low-dose cholecalciferol in multiple sclerosis. Neurology, 86(4), 382–390. https://doi.org/10.1212/WNL.0000000000002316
Sotirchos, Elias S., Pavan Bhargava, Christopher Eckstein, Keith Van Haren, Moira Baynes, Achilles Ntranos, Anne Gocke, Lawrence Steinman, Ellen M. Mowry, and Peter A. Calabresi. “Safety and immunologic effects of high- vs low-dose cholecalciferol in multiple sclerosis.Neurology 86, no. 4 (January 26, 2016): 382–90. https://doi.org/10.1212/WNL.0000000000002316.
Sotirchos ES, Bhargava P, Eckstein C, Van Haren K, Baynes M, Ntranos A, et al. Safety and immunologic effects of high- vs low-dose cholecalciferol in multiple sclerosis. Neurology. 2016 Jan 26;86(4):382–90.
Sotirchos, Elias S., et al. “Safety and immunologic effects of high- vs low-dose cholecalciferol in multiple sclerosis.Neurology, vol. 86, no. 4, Jan. 2016, pp. 382–90. Pubmed, doi:10.1212/WNL.0000000000002316.
Sotirchos ES, Bhargava P, Eckstein C, Van Haren K, Baynes M, Ntranos A, Gocke A, Steinman L, Mowry EM, Calabresi PA. Safety and immunologic effects of high- vs low-dose cholecalciferol in multiple sclerosis. Neurology. 2016 Jan 26;86(4):382–390.

Published In

Neurology

DOI

EISSN

1526-632X

Publication Date

January 26, 2016

Volume

86

Issue

4

Start / End Page

382 / 390

Location

United States

Related Subject Headings

  • Vitamin D
  • Treatment Outcome
  • Pilot Projects
  • Neurology & Neurosurgery
  • Multiple Sclerosis, Relapsing-Remitting
  • Middle Aged
  • Male
  • Interleukin-17
  • Immunologic Factors
  • Humans