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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01225289
Other study ID # 88-03-27-9576
Secondary ID
Status Completed
Phase Phase 4
First received September 6, 2010
Last updated February 12, 2014
Start date October 2009
Est. completion date January 2014

Study information

Verified date February 2014
Source Tehran University of Medical Sciences
Contact n/a
Is FDA regulated No
Health authority Iran: Ministry of Health
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 36
Est. completion date January 2014
Est. primary completion date December 2013
Accepts healthy volunteers No
Gender Both
Age group 20 Years to 45 Years
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Vitamin A
25000 IU/day (one capsule per day) Vitamin A for 6 months
Drug:
Placebo
1 capsule per day for six months

Locations

Country Name City State
Iran, Islamic Republic of Tehran University of Medical Sciences, School of Public Health Tehran
Iran, Islamic Republic of Tehran University of Medical Sciences, School of Public Health Tehran, Tehran, Iran, Islamic Republic o Tehran

Sponsors (1)

Lead Sponsor Collaborator
Tehran University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Difference Serum Levels of High-sensitive C-reactive Protein (Hs-CRP), Before and After of Supplementation first day and after 6 month No
Secondary Difference of IL-4 Levels in Supernatant of Peripheral Blood Mononucleated Cells (PBMCs) Stimulated With Phytohemagglutinin (PHA), Before and After of Supplementation first day and after 6 month No
Secondary Difference of Retinol Binding Protein (RBP) / Transthyretin (TTR) Ratio, (Difference of RBP/ TTR Ratio), Before and After of Supplementation first day and after 6 month No
Secondary Peripheral Blood Mononucleated Cells (PBMCs) Proliferation Assay (BrdU Colorimetric) difference of PBMCs proliferation stimulated with myelin oligodendrocyte glycoprotein (MOG), before and after of supplementation first day and after 6 month No
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