Impact of Vitamin A on Multiple Sclerosis (MS)

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Relapsing Remitting Multiple Sclerosis

Intervention / Treatment
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* Dietary Supplement: vitamin A
* Drug: Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who have used interferon beta in last 3 months Patients with 0-5 EDSS Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: vitamin A, multiple sclerosis,<br>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 | Dietary Supplement: vitamin A<br>* 1 cap vitamin A 25000 IU/day for 6 months and 10000 IU/day for next 6 months<br>Drug: Drug: placebo<br>* 1 cap placebo/day for 12 month<br>|
| Placebo Comparator: placebo/Multiple Sclerosis<br>Patients with Multiple Sclerosis confirmed Relapsing Remitting Type who receive 1 cap of placebo/day | Dietary Supplement: vitamin A<br>* 1 cap vitamin A 25000 IU/day for 6 months and 10000 IU/day for next 6 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Expanded Disability Status Scale (EDSS) | Expanded Disability Status Scale (EDSS) as a measure of activity and progression of MS disease | Change from baseline at 12 months | 
| Multiple Sclerosis Functional Composite (MSFC) | Multiple Sclerosis Functional Composite (MSFC) as a measure of activity and progression of MS disease | Change from baseline at 12 months | 
| fatigue scores | fatigue scores on Multiple Sclerosis Fatigue Impact Scale | Change from baseline at 12 months | 
| depression score | depression score on Beck Depression Inventory 2 | Change from baseline at 12 months | 
| Number of active lesion in magnetic resonance imaging (MRI) number of active lesion in brain MRI | Number of active lesion in magnetic resonance imaging (MRI) as a measure of activity and progression of MS disease | Change from baseline at 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of disease relapses | To measure the effect of vitamin A supplementation on number of disease relapses | Change from baseline at 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Multiple sclerosis, immune system, vitamin A, (MSFC)Multiple Sclerosis Functional Composite, (EDSS)Expanded Disability Status Scale, (MRI)Magnetic resonance imaging