Impact of Vitamin A Supplementation on Immune System in Multiple Sclerosis Patients

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2014-01-31

Brief Summary

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The aim of this study is to study the comparison between the effects of supplementation with 25000 IU preformed vitamin A (retinyl palmitate) or placebo for 6 months on immune system and Th1/Th2 balance in patients with Multiple Sclerosis.

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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 IFN-g, 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 (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

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 MS confirmed Relapsing Remitting Type who receive 25000 IU/day vitamin A

Group Type ACTIVE_COMPARATOR

Vitamin A

Intervention Type DIETARY_SUPPLEMENT

25000 IU/day (one capsule per day) Vitamin A for 6 months

with Multiple Sclerosis/ placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

1 capsule per day for six months

Interventions

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Vitamin A

25000 IU/day (one capsule per day) Vitamin A for 6 months

Intervention Type DIETARY_SUPPLEMENT

Placebo

1 capsule per day for six months

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 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