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

To study the safety profile and characterize the immunologic effects of high- vs low-dose cholecalciferol supplementation in patients with multiple sclerosis (MS). In this double-blind, single-center randomized pilot study, 40 patients with relapsing-remitting MS were randomized to receive 10,400 IU...

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Veröffentlicht in:Neurology Jg. 86; H. 4; S. 382
Hauptverfasser: Sotirchos, Elias S, Bhargava, Pavan, Eckstein, Christopher, Van Haren, Keith, Baynes, Moira, Ntranos, Achilles, Gocke, Anne, Steinman, Lawrence, Mowry, Ellen M, Calabresi, Peter A
Format: Journal Article
Sprache:Englisch
Veröffentlicht: United States 26.01.2016
Schlagworte:
Adult
CD4 Lymphocyte Count
CD4-Positive T-Lymphocytes - metabolism
Cholecalciferol - administration & dosage
Cholecalciferol - adverse effects
Cholecalciferol - pharmacology
Dietary Supplements
Double-Blind Method
Female
Humans
Immunologic Factors - administration & dosage
Immunologic Factors - adverse effects
Immunologic Factors - pharmacology
Interleukin-17 - metabolism
Male
Middle Aged
Multiple Sclerosis, Relapsing-Remitting - drug therapy
Multiple Sclerosis, Relapsing-Remitting - immunology
Pilot Projects
Treatment Outcome
Vitamin D - analogs & derivatives
Vitamin D - blood
ISSN:1526-632X, 1526-632X
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Zusammenfassung:To study the safety profile and characterize the immunologic effects of high- vs low-dose cholecalciferol supplementation in patients with multiple sclerosis (MS). 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. 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. 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. 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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ISSN:1526-632X
1526-632X
DOI:10.1212/WNL.0000000000002316