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

Phase 4

• Conditions: Relapsing Remitting Multiple Sclerosis
• Interventions: Dietary Supplement: vitamin A

• Registration Number: NCT01407211
• Lead Sponsor: Tehran University of Medical Sciences

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2011-02-14
• Study Start: 2011-04
• Study First Submitted QC: 2011-07-30
• Study First Posted: 2011-08-02
• Status Verified: 2012-07
• Last Update Submitted: 2012-07-17
• Last Update Posted: 2012-07-18
• Primary Completion: 2013-04
• Study Completion: 2013-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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. -

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
with Multiple Sclerosis/ placebo	vitamin A	Patients with Multiple Sclerosis confirmed Relapsing Remitting Type who receive 1 cap of placebo/day
with Multiple Sclerosis/ vitamin A	vitamin A	Patients with Multiple Sclerosis confirmed Relapsing Remitting Type who receive 25000 IU/day vitamin A

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
gene expression of T-bet, INF-gamma, IL-4, GATA3, IL-17, RORc, IL-10, FOXP3 (Relative quantification)	Change from baseline at 6 months

Trial Locations

Locations (1)

Tehran University of Medical Sciences, School of Public Health; 🇮🇷 Tehran, Iran, Islamic Republic of