Relapsing Remitting Multiple Sclerosis
Conditions
Keywords
Multiple sclerosis, immune system, vitamin A, (MSFC)Multiple Sclerosis Functional Composite, (EDSS)Expanded Disability Status Scale, (MRI)Magnetic resonance imaging
Brief summary
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.
Detailed 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.
Interventions
DIETARY_SUPPLEMENTvitamin A
1 cap vitamin A 25000 IU/day for 6 months and 10000 IU/day for next 6 months
DRUGDrug: placebo
1 cap placebo/day for 12 month
Sponsors
Tehran University of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 45 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| depression score | Change from baseline at 12 months | depression score on Beck Depression Inventory 2 |
| Multiple Sclerosis Functional Composite (MSFC) | Change from baseline at 12 months | Multiple Sclerosis Functional Composite (MSFC) as a measure of activity and progression of MS disease |
| fatigue scores | Change from baseline at 12 months | fatigue scores on Multiple Sclerosis Fatigue Impact Scale |
| Expanded Disability Status Scale (EDSS) | Change from baseline at 12 months | Expanded Disability Status Scale (EDSS) as a measure of activity and progression of MS disease |
| Number of active lesion in magnetic resonance imaging (MRI) number of active lesion in brain MRI | Change from baseline at 12 months | Number of active lesion in magnetic resonance imaging (MRI) as a measure of activity and progression of MS disease |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| number of disease relapses | Change from baseline at 12 months | To measure the effect of vitamin A supplementation on number of disease relapses |
Countries
Iran
Outcome results
None listed