Impact of Vitamin A on RAR Gene Expression in Multiple Sclerosis

Relapsing Remitting Multiple Sclerosis Clinical Trial

— RAR  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01705457
• Other study ID #: 91-03-161-19476
• Status: Enrolling by invitation
• Phase: Phase 4
• First received: October 9, 2012
• Last updated: October 11, 2012
• Start date: February 2010
• Est. completion date: August 2013

Study information

• Verified date: October 2012
• Source: Tehran University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 20
• Est. completion date: August 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 45 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting
• Relapsing Remitting Multiple Sclerosis
• Sclerosis

Intervention

Drug:
• Dietary Supplement: vitamin A
25000 IU/day vitamin A for 6 months 1 Cap/Day 1 cap placebo/day for 6 month
• placebo

Locations

Country	Name	City	State
Iran, Islamic Republic of	Tehran University of Medical Sciences,	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Tehran University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gene expression of RAR(Relative quantification)		Change from baseline at 6 months	No