Impact of Vitamin A Supplementation on Immune System in Multiple Sclerosis Patients
Primary Purpose
Relapsing Remitting Multiple Sclerosis
Status
Completed
Phase
Phase 4
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Vitamin A
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Relapsing Remitting Multiple Sclerosis focused on measuring Multiple Sclerosis, Vitamin A, CD4-Positive T-Lymphocytes, 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 Tehran, Tehran, Iran, Islamic Republic o
- 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 MS 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 per day
Outcomes
Primary Outcome Measures
Difference Serum Levels of High-sensitive C-reactive Protein (Hs-CRP), Before and After of Supplementation
Secondary Outcome Measures
Difference of IL-4 Levels in Supernatant of Peripheral Blood Mononucleated Cells (PBMCs) Stimulated With Phytohemagglutinin (PHA), Before and After of Supplementation
Difference of Retinol Binding Protein (RBP) / Transthyretin (TTR) Ratio, (Difference of RBP/ TTR Ratio), Before and After of Supplementation
Peripheral Blood Mononucleated Cells (PBMCs) Proliferation Assay (BrdU Colorimetric)
difference of PBMCs proliferation stimulated with myelin oligodendrocyte glycoprotein (MOG), before and after of supplementation
Full Information
NCT ID
NCT01225289
First Posted
September 6, 2010
Last Updated
February 12, 2014
Sponsor
Tehran University of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT01225289
Brief Title
Impact of Vitamin A Supplementation on Immune System in Multiple Sclerosis Patients
Official Title
The Study of the Effects of Vitamin A Supplementation on Immune System and Th1/Th2 Balance in Patients With Multiple Sclerosis
Study Type
Interventional
2. Study Status
Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
January 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
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 to study the comparison between the effects of supplementation with 25000 IU preformed vitamin A (retinyl palmitate) or placebo for 6 months on immune system and Th1/Th2 balance 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 IFN-g, 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 (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, Vitamin A, CD4-Positive T-Lymphocytes, 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
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
with Multiple Sclerosis/ vitamin A
Arm Type
Active Comparator
Arm Description
Patients with MS 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 per day
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin A
Other Intervention Name(s)
Retinyl palmitate
Intervention Description
25000 IU/day (one capsule per day) Vitamin A for 6 months
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
1 capsule per day for six months
Primary Outcome Measure Information:
Title
Difference Serum Levels of High-sensitive C-reactive Protein (Hs-CRP), Before and After of Supplementation
Time Frame
first day and after 6 month
Secondary Outcome Measure Information:
Title
Difference of IL-4 Levels in Supernatant of Peripheral Blood Mononucleated Cells (PBMCs) Stimulated With Phytohemagglutinin (PHA), Before and After of Supplementation
Time Frame
first day and after 6 month
Title
Difference of Retinol Binding Protein (RBP) / Transthyretin (TTR) Ratio, (Difference of RBP/ TTR Ratio), Before and After of Supplementation
Time Frame
first day and after 6 month
Title
Peripheral Blood Mononucleated Cells (PBMCs) Proliferation Assay (BrdU Colorimetric)
Description
difference of PBMCs proliferation stimulated with myelin oligodendrocyte glycoprotein (MOG), before and after of supplementation
Time Frame
first day and after 6 month
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ali Akbar Saboor Yaraghi, PhD
Organizational Affiliation
Tehran University of Medical Sciences
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sima Jafarirad, PhD student
Organizational Affiliation
Tehran University of Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tehran University of Medical Sciences, School of Public Health Tehran, Tehran, Iran, Islamic Republic o
City
Tehran
Country
Iran, Islamic Republic of
Facility Name
Tehran University of Medical Sciences, School of Public Health
City
Tehran
Country
Iran, Islamic Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
23868508
Citation
Mohammadzadeh Honarvar N, Harirchian MH, Koohdani F, Siassi F, Abdolahi M, Bitarafan S, Salehi E, Sahraian MA, Eshraghian MR, Saboor-Yarghi AA. The effect of vitamin A supplementation on retinoic acid-related orphan receptor gammat (RORgammat) and interleukin-17 (IL-17) gene expression in Avonex-treated multiple sclerotic patients. J Mol Neurosci. 2013 Nov;51(3):749-53. doi: 10.1007/s12031-013-0058-9. Epub 2013 Jul 19.
Results Reference
derived
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Impact of Vitamin A Supplementation on Immune System in Multiple Sclerosis Patients
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