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临床试验/NCT00940719
NCT00940719已完成不适用

The Effects of Vitamin D3 Supplementation on the T Cell Compartment in Multiple Sclerosis; a Pilot Study

Maastricht University Medical Center2 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2009年8月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
15
试验地点
2
主要终点
T cell regulation

研究概览

简要总结

In patients with Relapsing Remitting Multiple Sclerosis (RRMS), the investigators observed a positive correlation between regulatory T cell (Treg) function and vitamin D status. The present goal is to assess whether Treg function improves on supplementation with vitamin D3.

详细描述

In several studies, Multiple Sclerosis (MS) incidence and disease activity has been related with vitamin D status. We observed that RRMS patients who remained relapse free before blood collection had a better vitamin D status than patients who experienced relapses (Smolders et al. Mult Scler 2008;17:1220-1224). Since vitamin D3 is a potent promotor of T cell regulation in vitro (Smolders et al. J Neuroimmunol 2008;194:7-17), we hypothesised that a promotion of Treg function in MS patients might underlie its association with MS disease activity. In a cohort of RRMS patients, we observed a positive correlation of Treg function with vitamin D status (Smolders et al. PLoS ONE 2009;4:e6635). Furthermore, vitamin D status correlated positively with a Th1/Th2-balance which was more directed towards Th2. In the present study, we will assess whether treatment of RRMS patients with vitamin D3 promotes T cell regulation.

In the present study, RRMS patients will be supplemented with vitamin D3, and regulatory T cell tests will be performed before and after supplementation.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Relapsing Remitting MS (Revised MCDonald criteria 2005)
  • Age > 18 years

排除标准

  • Progressive MS phenotype
  • Abnormalities of vitamin D hormonal system other than low dietary intake or limited sun exposure
  • Intake of drugs that influence vitamin D homeostasis other than corticosteroids
  • Conditions with in increased susceptibility to hypercalcemia
  • Alcohol or drug abuse
  • Pregnancy or the intention to become pregnant within the study period

结局指标

主要结局

T cell regulation

时间窗: 3 months

次要结局

  • serum 25-hydroxyvitamin D levels(3 months)
  • calcium metabolism(3 months)

研究者

申办方类型
Other

研究点 (2)

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