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

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

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.

Study Overview

• Status: Unknown
• Conditions: Relapsing Remitting Multiple Sclerosis
• Intervention / Treatment: Dietary supplement: vitamin A

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 Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 4

Contacts and Locations

Study Locations

• Iran, Islamic Republic of
  • Tehran, Iran, Islamic Republic of
    • Tehran University of Medical Sciences, School of Public Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: with Multiple Sclerosis/ vitamin A; Patients with Multiple Sclerosis confirmed Relapsing Remitting Type who receive 25000 IU/day vitamin A	Dietary supplement: vitamin A; 25000 IU/day vitamin A 6 months 1 Cap/Day 1 cap placebo/day for 6 month
Placebo Comparator: with Multiple Sclerosis/ placebo; Patients with Multiple Sclerosis confirmed Relapsing Remitting Type who receive 1 cap of placebo/day	Dietary supplement: vitamin A; 25000 IU/day vitamin A 6 months 1 Cap/Day 1 cap placebo/day for 6 month

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Tehran University of Medical Sciences

Study record dates

Study Major Dates

• Study Start: April 1, 2011
• Primary Completion (Anticipated): April 1, 2013
• Study Completion (Anticipated): September 1, 2013

Study Registration Dates

• First Submitted: February 14, 2011
• First Submitted That Met QC Criteria: July 30, 2011
• First Posted (Estimate): August 2, 2011

Study Record Updates

• Last Update Posted (Estimate): July 18, 2012
• Last Update Submitted That Met QC Criteria: July 17, 2012
• Last Verified: July 1, 2012

More Information

Terms related to this study

• Keywords: multiple sclerosis; gene expression; Vitamin A; CD4-Positive T-Lymphocytes; Th1 Cells; Th2 Cells; Myelin Oligodendrocyte Glycoprotein(MOG)
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Physiological Effects of Drugs; Micronutrients; Vitamins; Vitamin A
• Other Study ID Numbers: 89/8/18-10033