Clinical trial NCT01407211: Impact of Vitamin A on Gene Expression, in Multiple Sclerosis Patient
Official title: The Impact of Vitamin A Supplementation on Gene Expression of Cytokine Secreted by CD4+ T Lymphocyte in Multiple Sclerosis Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Relapsing Remitting Multiple Sclerosis
Keywords: multiple sclerosis
Myelin Oligodendrocyte Glycoprotein(MOG)
Vitamin A
CD4-Positive T-Lymphocytes
gene expression
Th1 Cells
Th2 Cells
Lead sponsor: Tehran University of Medical Sciences
Sponsor class: OTHER
First posted: 2011-08-02
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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. -

Primary outcomes:
measure: serum Total cholesterol
timeFrame: Change from baseline at 6 months
measure: serum HDL cholesterol
timeFrame: Change from baseline at 6 months
measure: serum triglycerides level
timeFrame: Change from baseline at 6 months
measure: RBP/ TTR ratio
timeFrame: Change from baseline at 6 months
measure: PBMC's prolifration(BrdU colorimetric)
timeFrame: Change from baseline at 6 months
measure: complete blood count (CBC)
timeFrame: Change from baseline at 6 months
measure: serum SGOT concentration
timeFrame: Change from baseline at 6 months
measure: serum SGPT concentration
timeFrame: Change from baseline at 6 months
Secondary outcomes:
measure: gene expression of T-bet, INF-gamma, IL-4, GATA3, IL-17, RORc, IL-10, FOXP3 (Relative quantification)
timeFrame: Change from baseline at 6 months
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Tehran University of Medical Sciences, School of Public Health
Study officials:
References: