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

NCT ID: NCT01407211

Last Updated: 2012-07-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2013-09-30

Brief Summary

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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

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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.

Conditions

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Relapsing Remitting Multiple Sclerosis

Keywords

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multiple sclerosis Myelin Oligodendrocyte Glycoprotein(MOG) Vitamin A CD4-Positive T-Lymphocytes gene expression Th1 Cells Th2 Cells

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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with Multiple Sclerosis/ vitamin A

Patients with Multiple Sclerosis confirmed Relapsing Remitting Type who receive 25000 IU/day vitamin A

Group Type ACTIVE_COMPARATOR

vitamin A

Intervention Type DIETARY_SUPPLEMENT

25000 IU/day vitamin A 6 months

1 Cap/Day

1 cap placebo/day for 6 month

with Multiple Sclerosis/ placebo

Patients with Multiple Sclerosis confirmed Relapsing Remitting Type who receive 1 cap of placebo/day

Group Type PLACEBO_COMPARATOR

vitamin A

Intervention Type DIETARY_SUPPLEMENT

25000 IU/day vitamin A 6 months

1 Cap/Day

1 cap placebo/day for 6 month

Interventions

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vitamin A

25000 IU/day vitamin A 6 months

1 Cap/Day

1 cap placebo/day for 6 month

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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. -
Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tehran University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Tehran University of Medical Sciences, School of Public Health

Tehran, , Iran

Site Status

Countries

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Iran

Other Identifiers

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89/8/18-10033

Identifier Type: -

Identifier Source: org_study_id