<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/NCT01666587</url>
  </required_header>
  <id_info>
    <org_study_id>IRAPC</org_study_id>
    <secondary_id>DBD0300</secondary_id>
    <nct_id>NCT01666587</nct_id>
  </id_info>
  <brief_title>Ischemia Reperfusion: Prostaglandins and Antioxidants</brief_title>
  <official_title>The Role of Prostaglandin and Anti-oxidant Availability on Recovery From Forearm Ischemia-reperfusion Injury in Humans</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Essex</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Essex</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purposes of this study are two-fold. The first purpose is to determine the effect of&#xD;
      taking vitamins on the recovery of an artery (blood vessel) following an induced temporary&#xD;
      injury. The second purpose is to determine whether a specific vasodilator is less abundant&#xD;
      after the injury and whether this contributes to increased constriction or after the injury.&#xD;
      Finally, does vitamin consumption have an effect on the recovery from the injury if one of&#xD;
      the substances in the blood that causes vessels to enlarge (dilate) is stopped?&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">August 2013</completion_date>
  <primary_completion_date type="Actual">April 2013</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in flow mediated dilation</measure>
    <time_frame>Change from baseline at 15 minutes after ischemia-reperfusion injury</time_frame>
    <description>Flow mediated dilation is a measure of vascular function and is measured as the outcome before and after an injury to the inner lining of the artery.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in low flow mediated constriction</measure>
    <time_frame>Change from baseline at 15 minutes after ischemia-reperfusion injury</time_frame>
    <description>low flow mediated constriction is a measure of vascular function and is measured to establish the impact of a vascular injury</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Ischemic Reperfusion Injury</condition>
  <arm_group>
    <arm_group_label>control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Control trial to determine the impact of the ischemic injury on vascular function without intervention</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Antioxidant load</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Trial to determine the impact of an antioxidant load before the ischemic injury on vascular function recovery</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Prostaglandin inhibition</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Trial to determine the impact of a non-selective prostaglandin inhibitor before the ischemic injury on vascular function recovery</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Combined</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Trial to determine the impact of an antioxidant load and prostaglandin inhibitor before the ischemic injury on vascular function recovery</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Antioxidant</intervention_name>
    <arm_group_label>Antioxidant load</arm_group_label>
    <arm_group_label>Combined</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Prostaglandin inhibitor (Ibuprophen)</intervention_name>
    <arm_group_label>Combined</arm_group_label>
    <arm_group_label>Prostaglandin inhibition</arm_group_label>
    <other_name>ibuprofen</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy males&#xD;
&#xD;
          -  Healthy females&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Smokers&#xD;
&#xD;
          -  Cardiovascular disease&#xD;
&#xD;
          -  Peripheral vascular disease&#xD;
&#xD;
          -  Neurological deficits&#xD;
&#xD;
          -  Diabetes Type I or II&#xD;
&#xD;
          -  Pregnant women&#xD;
&#xD;
          -  Adverse reactions to Ibuprofen&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mark Rakobowchuk, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Thompson Rivers University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Essex</name>
      <address>
        <city>Colchester</city>
        <state>Essex</state>
        <zip>CO4 3SQ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>May 2017</verification_date>
  <study_first_submitted>August 9, 2012</study_first_submitted>
  <study_first_submitted_qc>August 15, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 16, 2012</study_first_posted>
  <last_update_submitted>May 10, 2017</last_update_submitted>
  <last_update_submitted_qc>May 10, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">May 12, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Essex</investigator_affiliation>
    <investigator_full_name>Mark Rakobowchuk</investigator_full_name>
    <investigator_title>Principle Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Reperfusion Injury</mesh_term>
    <mesh_term>Ischemia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ibuprofen</mesh_term>
    <mesh_term>Antioxidants</mesh_term>
    <mesh_term>Prostaglandin Antagonists</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/NCT01666587
org study id: IRAPC
secondary id: DBD0300
nct id: NCT01666587
lead sponsor: 
has dmc: Yes
The purposes of this study are two-fold. The first purpose is to determine the effect of
      taking vitamins on the recovery of an artery (blood vessel) following an induced temporary
      injury. The second purpose is to determine whether a specific vasodilator is less abundant
      after the injury and whether this contributes to increased constriction or after the injury.
      Finally, does vitamin consumption have an effect on the recovery from the injury if one of
      the substances in the blood that causes vessels to enlarge (dilate) is stopped?
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: Single (Participant)
measure: Change in flow mediated dilation
time frame: Change from baseline at 15 minutes after ischemia-reperfusion injury
description: Flow mediated dilation is a measure of vascular function and is measured as the outcome before and after an injury to the inner lining of the artery.
measure: Change in low flow mediated constriction
time frame: Change from baseline at 15 minutes after ischemia-reperfusion injury
description: low flow mediated constriction is a measure of vascular function and is measured to establish the impact of a vascular injury
arm group label: control
arm group type: No Intervention
description: Control trial to determine the impact of the ischemic injury on vascular function without intervention
arm group label: Antioxidant load
arm group type: Experimental
description: Trial to determine the impact of an antioxidant load before the ischemic injury on vascular function recovery
arm group label: Prostaglandin inhibition
arm group type: Experimental
description: Trial to determine the impact of a non-selective prostaglandin inhibitor before the ischemic injury on vascular function recovery
arm group label: Combined
arm group type: Experimental
description: Trial to determine the impact of an antioxidant load and prostaglandin inhibitor before the ischemic injury on vascular function recovery
intervention type: Dietary Supplement
intervention name: Antioxidant
arm group label: Antioxidant load
arm group label: Combined
intervention type: Drug
intervention name: Prostaglandin inhibitor (Ibuprophen)
arm group label: Combined
arm group label: Prostaglandin inhibition
other name: ibuprofen
criteria: 
gender: All
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Mark Rakobowchuk, PhD
role: Principal Investigator
affiliation: Thompson Rivers University
facility: 
country: United Kingdom
responsible party type: Principal Investigator
investigator affiliation: University of Essex
investigator full name: Mark Rakobowchuk
investigator title: Principle Investigator
mesh term: Reperfusion Injury
mesh term: Ischemia
mesh term: Ibuprofen
mesh term: Antioxidants
mesh term: Prostaglandin Antagonists