Impact of Vitamin A on Gene Expression, in Multiple Sclerosis Patient (MS)
Primary Purpose
Relapsing Remitting Multiple Sclerosis
Status
Unknown status
Phase
Phase 4
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
vitamin A
Sponsored by
About this trial
This is an interventional treatment trial for Relapsing Remitting Multiple Sclerosis focused on measuring multiple sclerosis, Myelin Oligodendrocyte Glycoprotein(MOG), Vitamin A, CD4-Positive T-Lymphocytes, gene expression, Th1 Cells, Th2 Cells
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. -
Sites / Locations
- Tehran University of Medical Sciences, School of Public Health
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
with Multiple Sclerosis/ vitamin A
with Multiple Sclerosis/ placebo
Arm Description
Patients with Multiple Sclerosis confirmed Relapsing Remitting Type who receive 25000 IU/day vitamin A
Patients with Multiple Sclerosis confirmed Relapsing Remitting Type who receive 1 cap of placebo/day
Outcomes
Primary Outcome Measures
serum Total cholesterol
serum HDL cholesterol
serum triglycerides level
RBP/ TTR ratio
PBMC's prolifration(BrdU colorimetric)
complete blood count (CBC)
serum SGOT concentration
serum SGPT concentration
Secondary Outcome Measures
gene expression of T-bet, INF-gamma, IL-4, GATA3, IL-17, RORc, IL-10, FOXP3 (Relative quantification)
Full Information
NCT ID
NCT01407211
First Posted
February 14, 2011
Last Updated
July 17, 2012
Sponsor
Tehran University of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT01407211
Brief Title
Impact of Vitamin A on Gene Expression, in Multiple Sclerosis Patient
Acronym
MS
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
2. Study Status
Record Verification Date
July 2012
Overall Recruitment Status
Unknown status
Study Start Date
April 2011 (undefined)
Primary Completion Date
April 2013 (Anticipated)
Study Completion Date
September 2013 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tehran University of Medical Sciences
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapsing Remitting Multiple Sclerosis
Keywords
multiple sclerosis, Myelin Oligodendrocyte Glycoprotein(MOG), Vitamin A, CD4-Positive T-Lymphocytes, gene expression, Th1 Cells, Th2 Cells
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
with Multiple Sclerosis/ vitamin A
Arm Type
Active Comparator
Arm Description
Patients with Multiple Sclerosis confirmed Relapsing Remitting Type who receive 25000 IU/day vitamin A
Arm Title
with Multiple Sclerosis/ placebo
Arm Type
Placebo Comparator
Arm Description
Patients with Multiple Sclerosis confirmed Relapsing Remitting Type who receive 1 cap of placebo/day
Intervention Type
Dietary Supplement
Intervention Name(s)
vitamin A
Intervention Description
25000 IU/day vitamin A 6 months
1 Cap/Day
1 cap placebo/day for 6 month
Primary Outcome Measure Information:
Title
serum Total cholesterol
Time Frame
Change from baseline at 6 months
Title
serum HDL cholesterol
Time Frame
Change from baseline at 6 months
Title
serum triglycerides level
Time Frame
Change from baseline at 6 months
Title
RBP/ TTR ratio
Time Frame
Change from baseline at 6 months
Title
PBMC's prolifration(BrdU colorimetric)
Time Frame
Change from baseline at 6 months
Title
complete blood count (CBC)
Time Frame
Change from baseline at 6 months
Title
serum SGOT concentration
Time Frame
Change from baseline at 6 months
Title
serum SGPT concentration
Time Frame
Change from baseline at 6 months
Secondary Outcome Measure Information:
Title
gene expression of T-bet, INF-gamma, IL-4, GATA3, IL-17, RORc, IL-10, FOXP3 (Relative quantification)
Time Frame
Change from baseline at 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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. -
Facility Information:
Facility Name
Tehran University of Medical Sciences, School of Public Health
City
Tehran
Country
Iran, Islamic Republic of
12. IPD Sharing Statement
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Impact of Vitamin A on Gene Expression, in Multiple Sclerosis Patient
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