Impact of Vitamin A on RAR Gene Expression in Multiple Sclerosis

Phase 4

• Conditions: Relapsing Remitting Multiple Sclerosis
• Interventions: Drug: placebo

• Registration Number: NCT01705457
• Lead Sponsor: Tehran University of Medical Sciences

Brief Summary

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

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

Study Timeline

• Study Start: 2010-02
• Status Verified: 2012-10
• Study First Submitted: 2012-10-09
• Study First Submitted QC: 2012-10-11
• Last Update Submitted: 2012-10-11
• Study First Posted: 2012-10-12
• Last Update Posted: 2012-10-12
• Primary Completion: 2013-02
• Study Completion: 2013-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
with multiple sclerosis,placebo	placebo	Patients with Multiple Sclerosis confirmed Relapsing Remitting Type

Primary Outcome Measures

Name	Time	Method
Gene expression of RAR(Relative quantification)	Change from baseline at 6 months

Trial Locations

Locations (1)

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