<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/NCT02251626</url>
  </required_header>
  <id_info>
    <org_study_id>2013P001111</org_study_id>
    <nct_id>NCT02251626</nct_id>
  </id_info>
  <brief_title>Assessing Bioavailability of CoQ10 Supplementation in Burn Patients</brief_title>
  <acronym>CoQ10</acronym>
  <official_title>Assessing Bioavailability and Effects of Ubiquinol Supplementation on Biomarkers of Mitochondrial Function/Integrity, Metabolic Dysfunction, and Circulating Alarmins in Burn Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Massachusetts General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Kaneka Medical America LLC</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Massachusetts General Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To test the hypotheses that plasma and intracellular coenzyme Q10 levels will decline after&#xD;
      burn injury and that ubiquinol supplementation will increase plasma and intracellular&#xD;
      coenzyme Q10 levels in burn patients.&#xD;
&#xD;
      To test the hypothesis that ubiquinol supplementation ameliorates mitochondrial&#xD;
      dysfunction/disintegrity and metabolic derangements, and decreases circulating alarmins&#xD;
      (a.k.a. endogenous DAMPs) in burn patients as compared with placebo.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Based on previous clinical studies and our preliminary preclinical data, we want to test the&#xD;
      hypotheses that plasma and intracellular coenzyme Q10 levels are decreased after burn injury&#xD;
      and that coenzyme Q10 (ubiquinol) supplementation reverses or ameliorates insulin resistance,&#xD;
      metabolic derangements, mitochondrial dysfunction, and increased circulating DAMPs in burn&#xD;
      patients. The aforementioned previous studies and preliminary data warrant a small-scale&#xD;
      clinical study to evaluate coenzyme Q10 status, and bioavailability and efficacy of coenzyme&#xD;
      Q10 (ubiquinol) supplementation in burn patients. Coenzyme Q10 (ubiquinol) supplementation&#xD;
      could represent a novel, safe and low-cost strategy to improve the clinical outcome of burn&#xD;
      patients. We are conducting a randomized, double-blind, placebo-controlled intervention study&#xD;
      with anticipated enrollment of 50 subjects. Adult burn patients with 5% or greater of total&#xD;
      body surface area (TBSA) burn at the Massachusetts General Hospital (MGH) Burn Center will be&#xD;
      approached to consider study participation. All enrolled patients will be randomized to&#xD;
      receive coenzyme Q10 (ubiquinol) supplementation or placebo. Blood samples will be used for&#xD;
      evaluation of coenzyme Q10 concentration, mitochondrial DNA copy number, non-mitochondrial&#xD;
      DAMPs (e.g., cell-free total DNA), and defective neutrophil migration.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>April 2014</start_date>
  <completion_date type="Anticipated">June 2017</completion_date>
  <primary_completion_date type="Anticipated">April 2017</primary_completion_date>
  <phase>Early Phase 1</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>Supportive Care</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Coenzyme Q10 Content in Peripheral Blood Mononuclear Cells</measure>
    <time_frame>up to four weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Plasma Coenzyme Q10 Concentration</measure>
    <time_frame>up to four weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Plasma Mitochondrial DNA Concentration</measure>
    <time_frame>up to four weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma cytokine concentrations</measure>
    <time_frame>up to four weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Burn Injury</condition>
  <arm_group>
    <arm_group_label>Coenzyme Q10 (ubiquinol)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Coenzyme Q10 (ubiquinol) group will be given 1,800 mg coenzyme Q10 (ubiquinol) per day</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo for CoQ10 (ubiquinol)</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo group will be given placebo only</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>coenzyme Q10</intervention_name>
    <description>It is a randomized and double blind study so patients or his/her doctor will not know which group s/he is in.</description>
    <arm_group_label>Coenzyme Q10 (ubiquinol)</arm_group_label>
    <other_name>Ubiquinol supplement</other_name>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>It is a randomized and double blind study so patients or his/her doctor will not know which group s/he is in.</description>
    <arm_group_label>Placebo for CoQ10 (ubiquinol)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Ages eligible for study: 18 years and older, and below 85 yeas old&#xD;
&#xD;
          -  Burn patients with 5% or greater of total body surface area burn&#xD;
&#xD;
          -  Nutrition support: routine oral and/or enteral nutrition&#xD;
&#xD;
          -  Enrolled within one week after burn injury&#xD;
&#xD;
          -  Patient or guardian who is capable of giving full informed consent.&#xD;
&#xD;
          -  Anticipated stay in the MGH Burn Unit: 5 days or more&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  &lt; 5% TBSA burn&#xD;
&#xD;
          -  Patients required full parenteral nutrition without oral or enteral nutrition support.&#xD;
&#xD;
          -  Patients with liver disease (bilirubin greater than 3)&#xD;
&#xD;
          -  Patients with thyroid disorders (thyroid disease which currently require treatment)&#xD;
&#xD;
          -  Patients with malignancy under treatment&#xD;
&#xD;
          -  Patients with mental illness who have impaired decision-making capacity (Mental&#xD;
             illness defined by the presence of psychotropic medications and/or the diagnosis of&#xD;
             psychiatric illness at the time of admission.) Patients with mental illness can be&#xD;
             included unless it is determined by the psychiatrist covering the burn unit that they&#xD;
             are unable to consent for themselves for other aspects of their care and treatment.)&#xD;
&#xD;
          -  Patients with HIV*&#xD;
&#xD;
          -  Pregnancy (as determined by routine admission labs)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Masao Kaneki, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Massachusetts General Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Masao Kaneki, MD, PhD</last_name>
    <phone>617-726-8122</phone>
    <email>mkaneki@helix.mgh.harvard.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Jeremy Goverman, MD</last_name>
    <phone>617-726-3712</phone>
    <email>JGOVERMAN@mgh.harvard.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Massachusetts General Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Masao Kaneki, MD, PhD</last_name>
      <phone>617-726-8122</phone>
      <email>mkaneki@helix.mgh.harvard.edu</email>
    </contact>
    <contact_backup>
      <last_name>Jeremy Goverman, MD</last_name>
      <phone>617-726-3712</phone>
      <email>JGOVERMAN@mgh.harvard.edu</email>
    </contact_backup>
    <investigator>
      <last_name>Masao Kaneki, MD. PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2016</verification_date>
  <study_first_submitted>September 20, 2014</study_first_submitted>
  <study_first_submitted_qc>September 25, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 29, 2014</study_first_posted>
  <last_update_submitted>September 13, 2016</last_update_submitted>
  <last_update_submitted_qc>September 13, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 15, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Massachusetts General Hospital</investigator_affiliation>
    <investigator_full_name>Masao Kaneki</investigator_full_name>
    <investigator_title>Associate Professor/Associate Biochemist, Department of Anesthesia,Critical Care and Pain Medicine</investigator_title>
  </responsible_party>
  <keyword>MGH</keyword>
  <keyword>Burn patient</keyword>
  <keyword>Adult</keyword>
  <keyword>CoQ10</keyword>
  <keyword>Ubiquinol</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Burns</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ubiquinone</mesh_term>
    <mesh_term>Coenzyme Q10</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT02251626
org study id: 2013P001111
nct id: NCT02251626
lead sponsor: 
collaborator: 
has dmc: Yes
To test the hypotheses that plasma and intracellular coenzyme Q10 levels will decline after
      burn injury and that ubiquinol supplementation will increase plasma and intracellular
      coenzyme Q10 levels in burn patients.

      To test the hypothesis that ubiquinol supplementation ameliorates mitochondrial
      dysfunction/disintegrity and metabolic derangements, and decreases circulating alarmins
      (a.k.a. endogenous DAMPs) in burn patients as compared with placebo.
Based on previous clinical studies and our preliminary preclinical data, we want to test the
      hypotheses that plasma and intracellular coenzyme Q10 levels are decreased after burn injury
      and that coenzyme Q10 (ubiquinol) supplementation reverses or ameliorates insulin resistance,
      metabolic derangements, mitochondrial dysfunction, and increased circulating DAMPs in burn
      patients. The aforementioned previous studies and preliminary data warrant a small-scale
      clinical study to evaluate coenzyme Q10 status, and bioavailability and efficacy of coenzyme
      Q10 (ubiquinol) supplementation in burn patients. Coenzyme Q10 (ubiquinol) supplementation
      could represent a novel, safe and low-cost strategy to improve the clinical outcome of burn
      patients. We are conducting a randomized, double-blind, placebo-controlled intervention study
      with anticipated enrollment of 50 subjects. Adult burn patients with 5% or greater of total
      body surface area (TBSA) burn at the Massachusetts General Hospital (MGH) Burn Center will be
      approached to consider study participation. All enrolled patients will be randomized to
      receive coenzyme Q10 (ubiquinol) supplementation or placebo. Blood samples will be used for
      evaluation of coenzyme Q10 concentration, mitochondrial DNA copy number, non-mitochondrial
      DAMPs (e.g., cell-free total DNA), and defective neutrophil migration.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Coenzyme Q10 Content in Peripheral Blood Mononuclear Cells
time frame: up to four weeks
measure: Plasma Coenzyme Q10 Concentration
time frame: up to four weeks
measure: Plasma Mitochondrial DNA Concentration
time frame: up to four weeks
measure: Plasma cytokine concentrations
time frame: up to four weeks
arm group label: Coenzyme Q10 (ubiquinol)
arm group type: Experimental
description: Coenzyme Q10 (ubiquinol) group will be given 1,800 mg coenzyme Q10 (ubiquinol) per day
arm group label: Placebo for CoQ10 (ubiquinol)
arm group type: Placebo Comparator
description: Placebo group will be given placebo only
intervention type: Dietary Supplement
intervention name: coenzyme Q10
description: It is a randomized and double blind study so patients or his/her doctor will not know which group s/he is in.
arm group label: Coenzyme Q10 (ubiquinol)
other name: Ubiquinol supplement
intervention type: Dietary Supplement
intervention name: Placebo
description: It is a randomized and double blind study so patients or his/her doctor will not know which group s/he is in.
arm group label: Placebo for CoQ10 (ubiquinol)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: Masao Kaneki, MD, PhD
role: Principal Investigator
affiliation: Massachusetts General Hospital
last name: Masao Kaneki, MD, PhD
phone: 617-726-8122
email: mkaneki@helix.mgh.harvard.edu
last name: Jeremy Goverman, MD
phone: 617-726-3712
email: JGOVERMAN@mgh.harvard.edu
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Massachusetts General Hospital
investigator full name: Masao Kaneki
investigator title: Associate Professor/Associate Biochemist, Department of Anesthesia,Critical Care and Pain Medicine
mesh term: Burns
mesh term: Ubiquinone
mesh term: Coenzyme Q10
sharing ipd: No