Impact of Vitamin A on RAR Gene Expression in Multiple Sclerosis

NCT ID: NCT01705457

Last Updated: 2012-10-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-02-28
• Study Completion Date: 2013-08-31

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

Conditions

Relapsing Remitting Multiple Sclerosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

with Multiple Sclerosis, vitamin A

Patients with Multiple Sclerosis confirmed Relapsing Remitting Type

Group Type: ACTIVE_COMPARATOR

Dietary Supplement: vitamin A

Intervention Type: DRUG

25000 IU/day vitamin A for 6 months

1 Cap/Day

1 cap placebo/day for 6 month

with multiple sclerosis,placebo

Patients with Multiple Sclerosis confirmed Relapsing Remitting Type

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

Interventions

Dietary Supplement: vitamin A

25000 IU/day vitamin A for 6 months

1 Cap/Day

1 cap placebo/day for 6 month

Intervention Type: DRUG

placebo

Intervention Type: DRUG

Other Intervention Names

Retinyl palmitate

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tehran University of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ali Akbar saboor Yaraghi, PhD

Role: STUDY_CHAIR

Tehran University of Medical Sciences

Sama Bitarafan, MD, PhD student

Role: PRINCIPAL_INVESTIGATOR

Tehran University of Medical Siences

Locations

Tehran University of Medical Sciences,

Tehran, , Iran

Countries

Iran

Other Identifiers

91-03-161-19476

Identifier Type: -

Identifier Source: org_study_id