Impact of Vitamin A on RAR Gene Expression in Multiple Sclerosis

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)on retinoic acid receptor and retinoic x receptor expression.

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 by increase of retinoic acid receptor and retinoic x receptor . Record Verification Date: August 2011

Official Title
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Impact of Vitamin A Supplementation on RAR Gene Expression in PBMC Cells in Multiple Sclerotic Patients

Conditions
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Relapsing Remitting Multiple Sclerosis

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: with Multiple Sclerosis, vitamin A<br>Patients with Multiple Sclerosis confirmed Relapsing Remitting Type | Drug: Dietary Supplement: vitamin A<br>* 25000 IU/day vitamin A for 6 months 1 Cap/Day 1 cap placebo/day for 6 month<br>* Other names: Retinyl palmitate;|
| Placebo Comparator: with multiple sclerosis,placebo<br>Patients with Multiple Sclerosis confirmed Relapsing Remitting Type | Drug: placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gene expression of RAR(Relative quantification) |  | Change from baseline at 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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multiple sclerosis, Vitamin A, retinoic acid receptor, retinoic x receptor