Financiado en parte por Pfizer, Biogen, Teva Pharmaceutical Industries, Prothena, EMD Serono
Safety and immunologic effects of high- vs low-dose cholecalciferol in multiple sclerosis
Sotirchos ES, Bhargava P, Eckstein C, Van Haren K, Baynes M, Ntranos A, Gocke A, Steinman L, Mowry EM, Calabresi PA
Neurology · 102 citas
Etiquetas de revisión
Financiado por la industriaDatos neutrales que nuestra revisión registró sobre cómo se hizo este estudio. Describen el método, nunca si nos gusta el resultado.
Cómo se estudió
- Diseño
- Ensayo controlado aleatorizado (indexado por PubMed)
- Estudiado en
- Personas
- Resultado principal
- Eventos clínicos como enfermedad o muerte
Quién lo pagó
- Financiación
- Financiado por la industria
- Organización sin fines de lucro
- National Multiple Sclerosis Society
- Empresa
- Pfizer
- Empresa
- Biogen
- Empresa
- Teva Pharmaceutical Industries
- Empresa
- Prothena
- Gobierno
- National Institutes of Health
- Empresa
- EMD Serono
- Gobierno
- National Institute of Neurological Disorders and Stroke
- Gobierno
- NINDS NIH HHS
- Subvenciones
- National Institute of Neurological Disorders and Stroke (K23 NS067055).); National Institute of Neurological Disorders and Stroke (K23 NS087151); National Institutes of Health (K23 NS067055)
Según 9 financiadores declarados.
Publicación
- Publicado
- 2015-12-30 · Neurology · vol. 86 · número 4 · págs. 382–390
- Editorial
- Lippincott Williams & Wilkins
- Citado
- 151 citas · más que el 99% de estudios similares · 12.8× el promedio de su campo
- Impacto
- Entre el 10 % más citado de su campo
- Referencias
- 38 trabajos
- Acceso
- Lectura gratuita
- Áreas de investigación
- Multiple Sclerosis Research Studies · Vitamin D Research Studies · Psoriasis: Treatment and Pathogenesis
- Palabras clave
- vitamin D3, vitamin D supplementation, multiple sclerosis, relapsing-remitting multiple sclerosis, high-dose vitamin D, immunomodulation, IL-17, CD4+ T cells, central memory T cells, naive T cells, effector memory T cells, 25-hydroxyvitamin D, treatment safety
- MeSH
- cd4-positive t-lymphocytes, humans, multiple sclerosis, relapsing-remitting, cholecalciferol, vitamin d, interleukin-17, immunologic factors, cd4 lymphocyte count, treatment outcome, pilot projects, double-blind method, dietary supplements, adult, middle aged, female, male
10 autores
- Elias S. Sotirchos🇺🇸Johns Hopkins University; Duke University; Johns Hopkins Medicine; Duke Medical Center; Stanford Medicine; Stanford University
- Pavan Bhargava🇺🇸Johns Hopkins University; Duke University; Johns Hopkins Medicine; Duke Medical Center; Stanford Medicine; Stanford University
- Christopher P. Eckstein🇺🇸Johns Hopkins University; Duke University; Johns Hopkins Medicine; Duke Medical Center; Stanford Medicine; Stanford University
- Keith P. van Haren🇺🇸Johns Hopkins University; Duke University; Johns Hopkins Medicine; Duke Medical Center; Stanford Medicine; Stanford University
- Moira Baynes🇺🇸Johns Hopkins University; Duke University; Johns Hopkins Medicine; Duke Medical Center; Stanford Medicine; Stanford University
- Achilles Ntranos🇺🇸Johns Hopkins University; Duke University; Johns Hopkins Medicine; Duke Medical Center; Stanford Medicine; Stanford University
- Anne R. Gocke🇺🇸Johns Hopkins University; Duke University; Johns Hopkins Medicine; Duke Medical Center; Stanford Medicine; Stanford University
- Lawrence Steinman🇺🇸Johns Hopkins University; Duke University; Johns Hopkins Medicine; Duke Medical Center; Stanford Medicine; Stanford University
- Ellen M. Mowry🇺🇸Johns Hopkins University; Duke University; Johns Hopkins Medicine; Duke Medical Center; Stanford Medicine; Stanford University
- Peter A. Calabresi🇺🇸Johns Hopkins University; Duke University; Johns Hopkins Medicine; Duke Medical Center; Stanford Medicine; Stanford University
Resumen
El texto original del estudio, en el idioma en que se publicó.
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.
Resumen vía Europe PMC. Los derechos de autor siguen siendo de los autores o la editorial.
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