Impact of Vitamin A on Multiple Sclerosis (MS)

Tehran University of Medical Sciences

Status and phase: Unknown; Phase 4

Conditions: Relapsing Remitting Multiple Sclerosis

Treatments: Dietary Supplement: vitamin A; Drug: Drug: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01417273

8887

Details and patient eligibility

About

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.

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 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.

Enrollment: 100 estimated 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 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups, including a placebo group

vitamin A, multiple sclerosis,

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: vitamin A

Drug: Drug: placebo

placebo/Multiple Sclerosis

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: vitamin A