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Impact of Vitamin A on RAR Gene Expression in Multiple Sclerosis

NCT ID: NCT01705457

Last Updated: 2012-10-12

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

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2013-08-31

Brief Summary

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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

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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

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Relapsing Remitting Multiple Sclerosis

Keywords

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multiple sclerosis Vitamin A retinoic acid receptor retinoic x receptor

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

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

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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

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Retinyl palmitate

Eligibility Criteria

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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

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Tehran University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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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

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Tehran University of Medical Sciences,

Tehran, , Iran

Site Status

Countries

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Iran

Other Identifiers

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91-03-161-19476

Identifier Type: -

Identifier Source: org_study_id