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临床试验/NCT01417273
NCT01417273Unknown4 期

Impact of Vitamin A Supplementation on Disease Activity and Progression in Multiple Sclerotic (MS) Patients

Tehran University of Medical Sciences1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2010年2月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
入组人数
100
试验地点
1
主要终点
Expanded Disability Status Scale (EDSS)

研究概览

简要总结

The aim of this study is the comparison between the effects of supplementation with 25000 IU preformed vitamin A (retinyl palmitate) or placebo for first 6 months and 10000 IU/day for next 6 months on disease activity and progression in patients with Multiple Sclerosis.

详细描述

Multiple Sclerosis (MS) is a chronic inflammatory disease where Th1 like responses from myelin-specific CD4+ T cells, as secretion of pro-inflammatory IFNγ, are believed to play a major role in the pathogenesis. The myelin-specific T cells that mediate tissue destruction in MS are believed to become activated outside the central nervous system (CNS) in lymphoid tissue and when they cross the blood brain barrier they will re-encounter their antigen. Immune deviation is the redirection of the immune response from most often Th1 like responses to Th2 like responses, even though the opposite can also occur. Vitamin A or Vitamin A-like analogs known as retinoids, are potent hormonal modifiers of type 1 or type 2 responses but a definitive description of their mechanism(s) of action is lacking. High level dietary vitamin A enhances Th2 cytokine production and IgA responses, and is likely to decrease Th1 cytokine production. Retinoic acid(RA) inhibits IL12 production in activated macrophages, and RA pretreatment of macrophages reduces IFNγ production and increases IL4 production in antigen primed CD4 T cells. Supplemental treatment with vitamin A or RA decreases IFNγ and increases IL5, IL10, and IL4 production.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Investigator)

入排标准

年龄范围
20 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patients who have used interferon beta in last 3 months
  • Patients with 0-5 EDSS

排除标准

  • Patients who have diseases which affect on Th1/Th2 balance such as asthma, active viral infections, and autoimmune diseases, OR
  • Patients who have allergy to vitamin A compounds, OR
  • Patients who have used vitamin supplements in last 3 months.

研究组 & 干预措施

vitamin A, multiple sclerosis,

Active Comparator

Patients with Multiple Sclerosis confirmed Relapsing Remitting Type who receive 25000 IU/day vitamin A for 6 months and 10000 IU/day for next 6 months

干预措施: vitamin A (Dietary Supplement)

placebo/Multiple Sclerosis

Placebo Comparator

Patients with Multiple Sclerosis confirmed Relapsing Remitting Type who receive 1 cap of placebo/day

干预措施: vitamin A (Dietary Supplement)

结局指标

主要结局

Expanded Disability Status Scale (EDSS)

时间窗: Change from baseline at 12 months

Expanded Disability Status Scale (EDSS) as a measure of activity and progression of MS disease

Multiple Sclerosis Functional Composite (MSFC)

时间窗: Change from baseline at 12 months

Multiple Sclerosis Functional Composite (MSFC) as a measure of activity and progression of MS disease

fatigue scores

时间窗: Change from baseline at 12 months

fatigue scores on Multiple Sclerosis Fatigue Impact Scale

depression score

时间窗: Change from baseline at 12 months

depression score on Beck Depression Inventory 2

Number of active lesion in magnetic resonance imaging (MRI) number of active lesion in brain MRI

时间窗: Change from baseline at 12 months

Number of active lesion in magnetic resonance imaging (MRI) as a measure of activity and progression of MS disease

次要结局

  • number of disease relapses(Change from baseline at 12 months)

研究者

申办方类型
Other

研究点 (1)

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