Impact of Vitamin A on Gene Expression, in Multiple Sclerosis Patient

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 vitamin A (retinyl palmitate) or placebo for 6 months on gene expression of T CD4+ lymphocyte in multiple sclerotic patient.

Detailed Description
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Multiple sclerosis (MS) is a chronic inflammatory demyelinating disease of the central nervous system (CNS).The most important reason for the limited success obtained in the treatment and prevention so far is most likely related to the limited knowledge about its cause and pathogenesis of MS.One of the recent proposed mechanism for autoimmunity base of MS is Th1/Th2 implance of as well as other inflammatory and anti-inflammatory T cell such as Th17 and Treg and their releasing cytokines. Therefore the control of cytokine production may become potential therapeutic targets and modulation of the Th1/Th2 balance may provide a new pharmacological tool to treat this disease. Vitamin A (VA) or VA-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 inhibits IL 12 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 retinoic acid (RA) decreases IFNγ and increases IL5, IL10, and IL4 production. Thus, vitamin A deficiency biases the immune response in a Th1 direction, whereas high level dietary vitamin A may bias the response in a Th2 direction.

Official Title
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The Impact of Vitamin A Supplementation on Gene Expression of Cytokine Secreted by CD4+ T Lymphocyte in Multiple Sclerosis Patients

Conditions
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Relapsing Remitting Multiple Sclerosis

Intervention / Treatment
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* Dietary Supplement: vitamin A


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 1-5 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 who receive 25000 IU/day vitamin A | Dietary Supplement: vitamin A<br>* 25000 IU/day vitamin A 6 months 1 Cap/Day 1 cap placebo/day for 6 month<br>|
| Placebo Comparator: with Multiple Sclerosis/ placebo<br>Patients with Multiple Sclerosis confirmed Relapsing Remitting Type who receive 1 cap of placebo/day | Dietary Supplement: vitamin A<br>* 25000 IU/day vitamin A 6 months 1 Cap/Day 1 cap placebo/day for 6 month<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| serum Total cholesterol |  | Change from baseline at 6 months | 
| serum HDL cholesterol |  | Change from baseline at 6 months | 
| serum triglycerides level |  | Change from baseline at 6 months | 
| RBP/ TTR ratio |  | Change from baseline at 6 months | 
| PBMC's prolifration(BrdU colorimetric) |  | Change from baseline at 6 months | 
| complete blood count (CBC) |  | Change from baseline at 6 months | 
| serum SGOT concentration |  | Change from baseline at 6 months | 
| serum SGPT concentration |  | Change from baseline at 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| gene expression of T-bet, INF-gamma, IL-4, GATA3, IL-17, RORc, IL-10, FOXP3 (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, Myelin Oligodendrocyte Glycoprotein(MOG), Vitamin A, CD4-Positive T-Lymphocytes, gene expression, Th1 Cells, Th2 Cells