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

Primary Purpose

Relapsing Remitting Multiple Sclerosis

Status
Unknown status
Phase
Phase 4
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Dietary Supplement: vitamin A
placebo
Sponsored by
Tehran University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Relapsing Remitting Multiple Sclerosis focused on measuring multiple sclerosis, Vitamin A, retinoic acid receptor, retinoic x receptor

Eligibility Criteria

20 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Tehran University of Medical Sciences,

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

with Multiple Sclerosis, vitamin A

with multiple sclerosis,placebo

Arm Description

Patients with Multiple Sclerosis confirmed Relapsing Remitting Type

Patients with Multiple Sclerosis confirmed Relapsing Remitting Type

Outcomes

Primary Outcome Measures

Gene expression of RAR(Relative quantification)

Secondary Outcome Measures

Full Information

First Posted
October 9, 2012
Last Updated
October 11, 2012
Sponsor
Tehran University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT01705457
Brief Title
Impact of Vitamin A on RAR Gene Expression in Multiple Sclerosis
Acronym
RAR
Official Title
Impact of Vitamin A Supplementation on RAR Gene Expression in PBMC Cells in Multiple Sclerotic Patients
Study Type
Interventional

2. Study Status

Record Verification Date
October 2012
Overall Recruitment Status
Unknown status
Study Start Date
February 2010 (undefined)
Primary Completion Date
February 2013 (Anticipated)
Study Completion Date
August 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tehran University of Medical Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapsing Remitting Multiple Sclerosis
Keywords
multiple sclerosis, Vitamin A, retinoic acid receptor, retinoic x receptor

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
with Multiple Sclerosis, vitamin A
Arm Type
Active Comparator
Arm Description
Patients with Multiple Sclerosis confirmed Relapsing Remitting Type
Arm Title
with multiple sclerosis,placebo
Arm Type
Placebo Comparator
Arm Description
Patients with Multiple Sclerosis confirmed Relapsing Remitting Type
Intervention Type
Drug
Intervention Name(s)
Dietary Supplement: vitamin A
Other Intervention Name(s)
Retinyl palmitate
Intervention Description
25000 IU/day vitamin A for 6 months 1 Cap/Day 1 cap placebo/day for 6 month
Intervention Type
Drug
Intervention Name(s)
placebo
Primary Outcome Measure Information:
Title
Gene expression of RAR(Relative quantification)
Time Frame
Change from baseline at 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ali Akbar saboor Yaraghi, PhD
Organizational Affiliation
Tehran University of Medical Sciences
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Sama Bitarafan, MD, PhD student
Organizational Affiliation
Tehran University of Medical Siences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tehran University of Medical Sciences,
City
Tehran
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

Learn more about this trial

Impact of Vitamin A on RAR Gene Expression in Multiple Sclerosis

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