<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01705457</url>
  </required_header>
  <id_info>
    <org_study_id>91-03-161-19476</org_study_id>
    <nct_id>NCT01705457</nct_id>
  </id_info>
  <brief_title>Impact of Vitamin A on RAR Gene Expression in Multiple Sclerosis</brief_title>
  <acronym>RAR</acronym>
  <official_title>Impact of Vitamin A Supplementation on RAR Gene Expression in PBMC Cells in Multiple Sclerotic Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tehran University of Medical Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Tehran University of Medical Sciences</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is the comparison between the effects of supplementation with 25000 IU&#xD;
      preformed vitamin A (retinyl palmitate)on retinoic acid receptor and retinoic x receptor&#xD;
      expression.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Multiple Sclerosis (MS) is a chronic inflammatory disease where Th1 like responses from&#xD;
      myelin-specific CD4+ T cells, as secretion of pro-inflammatory IFNγ, are believed to play a&#xD;
      major role in the pathogenesis. The myelin-specific T cells that mediate tissue destruction&#xD;
      in MS are believed to become activated outside the central nervous system (CNS) in lymphoid&#xD;
      tissue and when they cross the blood brain barrier they will re-encounter their antigen.&#xD;
      Immune deviation is the redirection of the immune response from most often Th1 like responses&#xD;
      to Th2 like responses, even though the opposite can also occur. Vitamin A or Vitamin A-like&#xD;
      analogs known as retinoids, are potent hormonal modifiers of type 1 or type 2 responses but a&#xD;
      definitive description of their mechanism(s) of action is lacking. High level dietary vitamin&#xD;
      A enhances Th2 cytokine production and IgA responses, and is likely to decrease Th1 cytokine&#xD;
      production. Retinoic acid(RA) inhibits IL12 production in activated macrophages, and RA&#xD;
      pretreatment of macrophages reduces IFNγ production and increases IL4 production in antigen&#xD;
      primed CD4 T cells. Supplemental treatment with vitamin A or RA decreases IFNγ and increases&#xD;
      IL5, IL10, and IL4 production by increase of retinoic acid receptor and retinoic x receptor .&#xD;
&#xD;
      Record Verification Date: August 2011&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date>February 2010</start_date>
  <completion_date type="Anticipated">August 2013</completion_date>
  <primary_completion_date type="Anticipated">February 2013</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Gene expression of RAR(Relative quantification)</measure>
    <time_frame>Change from baseline at 6 months</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Relapsing Remitting Multiple Sclerosis</condition>
  <arm_group>
    <arm_group_label>with Multiple Sclerosis, vitamin A</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients with Multiple Sclerosis confirmed Relapsing Remitting Type</description>
  </arm_group>
  <arm_group>
    <arm_group_label>with multiple sclerosis,placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Patients with Multiple Sclerosis confirmed Relapsing Remitting Type</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dietary Supplement: vitamin A</intervention_name>
    <description>25000 IU/day vitamin A for 6 months&#xD;
1 Cap/Day&#xD;
1 cap placebo/day for 6 month</description>
    <arm_group_label>with Multiple Sclerosis, vitamin A</arm_group_label>
    <other_name>Retinyl palmitate</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>placebo</intervention_name>
    <arm_group_label>with multiple sclerosis,placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients who have used interferon beta in last 3 months.&#xD;
&#xD;
          -  Patients with 0-5 EDSS&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who have diseases which affect on Th1/Th2 balance such as asthma, active&#xD;
             viral infections, and autoimmune diseases, OR&#xD;
&#xD;
          -  Patients who have allergy to vitamin A compounds, OR&#xD;
&#xD;
          -  Patients who have used vitamin supplements in last 3 months.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ali Akbar saboor Yaraghi, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Tehran University of Medical Sciences</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Sama Bitarafan, MD, PhD student</last_name>
    <role>Principal Investigator</role>
    <affiliation>Tehran University of Medical Siences</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Tehran University of Medical Sciences,</name>
      <address>
        <city>Tehran</city>
        <country>Iran, Islamic Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Iran, Islamic Republic of</country>
  </location_countries>
  <verification_date>October 2012</verification_date>
  <study_first_submitted>October 9, 2012</study_first_submitted>
  <study_first_submitted_qc>October 11, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 12, 2012</study_first_posted>
  <last_update_submitted>October 11, 2012</last_update_submitted>
  <last_update_submitted_qc>October 11, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 12, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>multiple sclerosis</keyword>
  <keyword>Vitamin A</keyword>
  <keyword>retinoic acid receptor</keyword>
  <keyword>retinoic x receptor</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Multiple Sclerosis</mesh_term>
    <mesh_term>Multiple Sclerosis, Relapsing-Remitting</mesh_term>
    <mesh_term>Sclerosis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vitamin A</mesh_term>
    <mesh_term>Retinol palmitate</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01705457
org study id: 91-03-161-19476
nct id: NCT01705457
lead sponsor: 
has dmc: Yes
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.
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
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Gene expression of RAR(Relative quantification)
time frame: Change from baseline at 6 months
arm group label: with Multiple Sclerosis, vitamin A
arm group type: Active Comparator
description: Patients with Multiple Sclerosis confirmed Relapsing Remitting Type
arm group label: with multiple sclerosis,placebo
arm group type: Placebo Comparator
description: Patients with Multiple Sclerosis confirmed Relapsing Remitting Type
intervention type: Drug
intervention name: Dietary Supplement: vitamin A
description: 25000 IU/day vitamin A for 6 months
1 Cap/Day
1 cap placebo/day for 6 month
arm group label: with Multiple Sclerosis, vitamin A
other name: Retinyl palmitate
intervention type: Drug
intervention name: placebo
arm group label: with multiple sclerosis,placebo
criteria: 
gender: All
minimum age: 20 Years
maximum age: 45 Years
healthy volunteers: No
last name: Ali Akbar saboor Yaraghi, PhD
role: Study Chair
affiliation: Tehran University of Medical Sciences
last name: Sama Bitarafan, MD, PhD student
role: Principal Investigator
affiliation: Tehran University of Medical Siences
facility: 
country: Iran, Islamic Republic of
responsible party type: Sponsor
mesh term: Multiple Sclerosis
mesh term: Multiple Sclerosis, Relapsing-Remitting
mesh term: Sclerosis
mesh term: Vitamin A
mesh term: Retinol palmitate