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

Tehran University of Medical Sciences

Status and phase: Completed; Phase 4

Conditions: Relapsing Remitting Multiple Sclerosis

Treatments: Drug: Placebo; Dietary Supplement: Vitamin A

Study type: Interventional

Funder types: Other

Identifiers

NCT01225289

88-03-27-9576

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 36 patients

Sex: All

Ages: 20 to 45 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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36 participants in 2 patient groups, including a placebo group

with Multiple Sclerosis/ vitamin A

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Vitamin A

with Multiple Sclerosis/ placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo