Impact of Vitamin A on Multiple Sclerosis (MS)

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

100 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) or placebo for first 6 months and 10000 IU/day for next 6 months on disease activity and progression 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 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.

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

DOUBLE

Participants Investigators

Study Groups

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vitamin A, multiple sclerosis,

Patients with Multiple Sclerosis confirmed Relapsing Remitting Type who receive 25000 IU/day vitamin A for 6 months and 10000 IU/day for next 6 months

Group Type ACTIVE_COMPARATOR

vitamin A

Intervention Type DIETARY_SUPPLEMENT

1 cap vitamin A 25000 IU/day for 6 months and 10000 IU/day for next 6 months

Drug: placebo

Intervention Type DRUG

1 cap placebo/day for 12 month

placebo/Multiple Sclerosis

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

1 cap vitamin A 25000 IU/day for 6 months and 10000 IU/day for next 6 months

Interventions

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vitamin A

1 cap vitamin A 25000 IU/day for 6 months and 10000 IU/day for next 6 months

Intervention Type DIETARY_SUPPLEMENT

Drug: placebo

1 cap placebo/day for 12 month

Intervention Type DRUG

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