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Impact of Vitamin A Supplementation on Immune System in Multiple Sclerosis Patients

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ClinicalTrials.gov Identifier: NCT01225289
Recruitment Status : Completed
First Posted : October 21, 2010
Results First Posted : March 14, 2014
Last Update Posted : March 14, 2014
Sponsor:
Information provided by (Responsible Party):
Ali Akbar Saboor Yaraghi, Tehran University of Medical Sciences

Study Description
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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.

Condition or disease Intervention/treatment Phase
Relapsing Remitting Multiple Sclerosis Dietary Supplement: Vitamin A Drug: Placebo Phase 4

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Study of the Effects of Vitamin A Supplementation on Immune System and Th1/Th2 Balance in Patients With Multiple Sclerosis
Study Start Date : October 2009
Actual Primary Completion Date : December 2013
Actual Study Completion Date : January 2014

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: with Multiple Sclerosis/ vitamin A
Patients with MS confirmed Relapsing Remitting Type who receive 25000 IU/day vitamin A
 Dietary Supplement: Vitamin A
25000 IU/day (one capsule per day) Vitamin A for 6 months
Other Name: Retinyl palmitate
Placebo Comparator: with Multiple Sclerosis/ placebo
Patients with Multiple Sclerosis confirmed Relapsing Remitting Type who receive 1 cap of placebo per day
 Drug: Placebo
1 capsule per day for six months


Outcome Measures
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Primary Outcome Measures :
  1. 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 Measures :
  1. 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 ]
  2. 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 ]
  3. Peripheral Blood Mononucleated Cells (PBMCs) Proliferation Assay (BrdU Colorimetric) [ Time Frame: first day and after 6 month ]
    difference of PBMCs proliferation stimulated with myelin oligodendrocyte glycoprotein (MOG), before and after of supplementation


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01225289


Locations
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Iran, Islamic Republic of
Tehran University of Medical Sciences, School of Public Health Tehran, Tehran, Iran, Islamic Republic o
Tehran, Iran, Islamic Republic of
Tehran University of Medical Sciences, School of Public Health
Tehran, Iran, Islamic Republic of
Sponsors and Collaborators
Tehran University of Medical Sciences
Investigators
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Principal Investigator: Ali Akbar Saboor Yaraghi, PhD Tehran University of Medical Sciences
Principal Investigator: Sima Jafarirad, PhD student Tehran University of Medical Sciences
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Ali Akbar Saboor Yaraghi, Assistant Professor, Tehran University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01225289    
Other Study ID Numbers: 88-03-27-9576
First Posted: October 21, 2010    Key Record Dates
Results First Posted: March 14, 2014
Last Update Posted: March 14, 2014
Last Verified: February 2014
Keywords provided by Ali Akbar Saboor Yaraghi, Tehran University of Medical Sciences:
Multiple Sclerosis
Vitamin A
CD4-Positive T-Lymphocytes
Th1 Cells
Th2 Cells
Additional relevant MeSH terms:
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Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
 Vitamin A
Retinol palmitate
Vitamins
Micronutrients
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Anticarcinogenic Agents
Antineoplastic Agents