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