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Impact of Vitamin A on RAR Gene Expression in Multiple Sclerosis (RAR)

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ClinicalTrials.gov Identifier: NCT01705457
Recruitment Status : Unknown
Verified October 2012 by Tehran University of Medical Sciences.
Recruitment status was:  Enrolling by invitation
First Posted : October 12, 2012
Last Update Posted : October 12, 2012
Sponsor:
Information provided by (Responsible Party):
Tehran University of Medical Sciences

Brief Summary:
The aim of this study is the comparison between the effects of supplementation with 25000 IU preformed vitamin A (retinyl palmitate)on retinoic acid receptor and retinoic x receptor expression.

Condition or disease Intervention/treatment Phase
Relapsing Remitting Multiple Sclerosis Drug: 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 IFNγ, 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 or Vitamin A-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(RA) inhibits IL12 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 RA decreases IFNγ and increases IL5, IL10, and IL4 production by increase of retinoic acid receptor and retinoic x receptor .

Record Verification Date: August 2011


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Impact of Vitamin A Supplementation on RAR Gene Expression in PBMC Cells in Multiple Sclerotic Patients
Study Start Date : February 2010
Estimated Primary Completion Date : February 2013
Estimated Study Completion Date : August 2013


Arm Intervention/treatment
Active Comparator: with Multiple Sclerosis, vitamin A
Patients with Multiple Sclerosis confirmed Relapsing Remitting Type
Drug: Dietary Supplement: vitamin A

25000 IU/day vitamin A for 6 months

1 Cap/Day

1 cap placebo/day for 6 month

Other Name: Retinyl palmitate

Placebo Comparator: with multiple sclerosis,placebo
Patients with Multiple Sclerosis confirmed Relapsing Remitting Type
Drug: placebo



Primary Outcome Measures :
  1. Gene expression of RAR(Relative quantification) [ Time Frame: Change from baseline at 6 months ]


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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 0-5 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.

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): NCT01705457


Locations
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Iran, Islamic Republic of
Tehran University of Medical Sciences,
Tehran, Iran, Islamic Republic of
Sponsors and Collaborators
Tehran University of Medical Sciences
Investigators
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Study Chair: Ali Akbar saboor Yaraghi, PhD Tehran University of Medical Sciences
Principal Investigator: Sama Bitarafan, MD, PhD student Tehran University of Medical Siences

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Responsible Party: Tehran University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01705457     History of Changes
Other Study ID Numbers: 91-03-161-19476
First Posted: October 12, 2012    Key Record Dates
Last Update Posted: October 12, 2012
Last Verified: October 2012
Keywords provided by Tehran University of Medical Sciences:
multiple sclerosis
Vitamin A
retinoic acid receptor
retinoic x receptor
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
Vitamins
Vitamin A
Retinol palmitate
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Anticarcinogenic Agents
Antineoplastic Agents