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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ali Akbar Saboor Yaraghi, Tehran University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01225289
First received: September 6, 2010
Last updated: February 12, 2014
Last verified: February 2014
  Purpose

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 Intervention Phase
Relapsing Remitting Multiple Sclerosis
Dietary Supplement: Vitamin A
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Tehran University of Medical Sciences:

Primary Outcome Measures:
  • Difference Serum Levels of High-sensitive C-reactive Protein (Hs-CRP), Before and After of Supplementation [ Time Frame: first day and after 6 month ] [ Designated as safety issue: No ]

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 [ Time Frame: first day and after 6 month ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Peripheral Blood Mononucleated Cells (PBMCs) Proliferation Assay (BrdU Colorimetric) [ Time Frame: first day and after 6 month ] [ Designated as safety issue: No ]
    difference of PBMCs proliferation stimulated with myelin oligodendrocyte glycoprotein (MOG), before and after of supplementation


Enrollment: 36
Study Start Date: October 2009
Study Completion Date: January 2014
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   20 Years to 45 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01225289

Locations
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, Iran, Islamic Republic of
Sponsors and Collaborators
Tehran University of Medical Sciences
Investigators
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

No publications provided by Tehran University of Medical Sciences

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ali Akbar Saboor Yaraghi, Assistant Professor, Tehran University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01225289     History of Changes
Other Study ID Numbers: 88-03-27-9576
Study First Received: September 6, 2010
Results First Received: October 29, 2013
Last Updated: February 12, 2014
Health Authority: Iran: Ministry of Health

Keywords provided by Tehran University of Medical Sciences:
Multiple Sclerosis
Vitamin A
CD4-Positive T-Lymphocytes
Th1 Cells
Th2 Cells

Additional relevant MeSH terms:
Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Sclerosis
Autoimmune Diseases
Autoimmune Diseases of the Nervous System
Demyelinating Autoimmune Diseases, CNS
Demyelinating Diseases
Immune System Diseases
Nervous System Diseases
Pathologic Processes
Retinol palmitate
Vitamin A
Vitamins
Anticarcinogenic Agents
Antineoplastic Agents
Antioxidants
Growth Substances
Micronutrients
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014