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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

September 6, 2010
February 12, 2014
October 2009
December 2013   (final data collection date for primary outcome measure)
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 ]
Serum levels of IL4, IL10, IFN γ, IL2, IL12 [ Time Frame: first day and after 6 month ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01225289 on ClinicalTrials.gov Archive Site
  • 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
  • PBMC supernatant levels of IL4, IL10, IFN γ, IL2, IL12 [ Time Frame: first day and after 6 month ] [ Designated as safety issue: No ]
  • RBP/ TTR ratio [ Time Frame: first day and after 6 month ] [ Designated as safety issue: No ]
  • lymphocyte proliferation assay (BrdU colorimetric) [ Time Frame: first day and after 6 month ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Impact of Vitamin A Supplementation on Immune System in Multiple Sclerosis Patients
The Study of the Effects of Vitamin A Supplementation on Immune System and Th1/Th2 Balance in Patients With Multiple Sclerosis

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Relapsing Remitting Multiple Sclerosis
  • Dietary Supplement: Vitamin A
    25000 IU/day (one capsule per day) Vitamin A for 6 months
    Other Name: Retinyl palmitate
  • Drug: Placebo
    1 capsule per day for six months
  • Active Comparator: with Multiple Sclerosis/ vitamin A
    Patients with MS confirmed Relapsing Remitting Type who receive 25000 IU/day vitamin A
    Intervention: Dietary Supplement: Vitamin A
  • Placebo Comparator: with Multiple Sclerosis/ placebo
    Patients with Multiple Sclerosis confirmed Relapsing Remitting Type who receive 1 cap of placebo per day
    Intervention: Drug: Placebo
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 γt (RORγt) 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
36
January 2014
December 2013   (final data collection date for primary outcome measure)

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.
Both
20 Years to 45 Years
No
Contact information is only displayed when the study is recruiting subjects
Iran, Islamic Republic of
 
NCT01225289
88-03-27-9576
Yes
Ali Akbar Saboor Yaraghi, Tehran University of Medical Sciences
Tehran University of Medical Sciences
Not Provided
Principal Investigator: Ali Akbar Saboor Yaraghi, PhD Tehran University of Medical Sciences
Principal Investigator: Sima Jafarirad, PhD student Tehran University of Medical Sciences
Tehran University of Medical Sciences
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP