Relapsing Remitting Multiple Sclerosis
Conditions
Keywords
multiple sclerosis, Myelin Oligodendrocyte Glycoprotein(MOG), Vitamin A, CD4-Positive T-Lymphocytes, gene expression, Th1 Cells, Th2 Cells
Brief summary
The aim of this study is the comparison between the effects of supplementation with vitamin A (retinyl palmitate) or placebo for 6 months on gene expression of T CD4+ lymphocyte in multiple sclerotic patient.
Detailed description
Multiple sclerosis (MS) is a chronic inflammatory demyelinating disease of the central nervous system (CNS).The most important reason for the limited success obtained in the treatment and prevention so far is most likely related to the limited knowledge about its cause and pathogenesis of MS.One of the recent proposed mechanism for autoimmunity base of MS is Th1/Th2 implance of as well as other inflammatory and anti-inflammatory T cell such as Th17 and Treg and their releasing cytokines. Therefore the control of cytokine production may become potential therapeutic targets and modulation of the Th1/Th2 balance may provide a new pharmacological tool to treat this disease. 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.
Interventions
DIETARY_SUPPLEMENTvitamin A
25000 IU/day vitamin A 6 months 1 Cap/Day 1 cap placebo/day for 6 month
Sponsors
Tehran University of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
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 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. -
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| serum SGPT concentration | Change from baseline at 6 months |
| serum Total cholesterol | Change from baseline at 6 months |
| serum HDL cholesterol | Change from baseline at 6 months |
| serum triglycerides level | Change from baseline at 6 months |
| RBP/ TTR ratio | Change from baseline at 6 months |
| PBMC's prolifration(BrdU colorimetric) | Change from baseline at 6 months |
| complete blood count (CBC) | Change from baseline at 6 months |
| serum SGOT concentration | Change from baseline at 6 months |
Secondary
| Measure | Time frame |
|---|---|
| gene expression of T-bet, INF-gamma, IL-4, GATA3, IL-17, RORc, IL-10, FOXP3 (Relative quantification) | Change from baseline at 6 months |
Countries
Iran
Outcome results
None listed