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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
100
1 cap vitamin A 25000 IU/day for 6 months and 10000 IU/day for next 6 months
1 cap placebo/day for 12 month
Tehran University of Medical Sciences,
Tehran, Iran
Expanded Disability Status Scale (EDSS)
Expanded Disability Status Scale (EDSS) as a measure of activity and progression of MS disease
Time frame: Change from baseline at 12 months
Multiple Sclerosis Functional Composite (MSFC)
Multiple Sclerosis Functional Composite (MSFC) as a measure of activity and progression of MS disease
Time frame: Change from baseline at 12 months
fatigue scores
fatigue scores on Multiple Sclerosis Fatigue Impact Scale
Time frame: Change from baseline at 12 months
depression score
depression score on Beck Depression Inventory 2
Time frame: Change from baseline at 12 months
Number of active lesion in magnetic resonance imaging (MRI) number of active lesion in brain MRI
Number of active lesion in magnetic resonance imaging (MRI) as a measure of activity and progression of MS disease
Time frame: Change from baseline at 12 months
number of disease relapses
To measure the effect of vitamin A supplementation on number of disease relapses
Time frame: Change from baseline at 12 months
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