<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/NCT04444349</url>
  </required_header>
  <id_info>
    <org_study_id>CoQ10-Jph 2020</org_study_id>
    <nct_id>NCT04444349</nct_id>
  </id_info>
  <brief_title>Effects of CoQ10 on Inflammatory Response in Cardiac Surgery</brief_title>
  <official_title>The Effects of the Dietary Supplement Coenzyme Q10 on Inflammatory Responses in Individuals With Cardiac Surgery: A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nanjing Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Nanjing Medical University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Cardiovascular diseases are the leading causes of death and prescription drug use. Research&#xD;
      on certain dietary supplements looks promising as a way to help reduce risk factors. Previous&#xD;
      studies showed that CoQ10 levels were decreased in cardiovascular patients and worsening of&#xD;
      mitochondrial dysfunction was observed. The overall objective of this study is to determine&#xD;
      if supplementing with CoQ10 can reduce inflammatory risk factors in adults with cardiac&#xD;
      surgery, independent of other dietary or physical activity changes.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">August 1, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2022</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2022</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>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Double (Care Provider, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>C-reactive protein</measure>
    <time_frame>Change from baseline of CRP in mg/L at 5 days after surgery.</time_frame>
    <description>Inflammatory and endothelial blood work biomarkers</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Interleukin-6</measure>
    <time_frame>Change from baseline of IL-6 in pg/mL at 5 days after surgery.</time_frame>
    <description>Inflammatory and endothelial blood work biomarkers</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">300</enrollment>
  <condition>Cardiovascular Disease</condition>
  <arm_group>
    <arm_group_label>Coenzyme Q10 group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in the experimental group will be given 10mg of Coenzyme Q10 each time (3 times a day).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Participants in the experimental group will be given 10mg of placebo each time (3 times a day).</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Coenzyme Q10</intervention_name>
    <description>Coenzyme Q10 is a cardiovascular health supplement. It is a component of the electron transport chain and participates in aerobic cellular respiration, which generates energy in the form of ATP. The ingredients in Coenzyme Q10 help regulate the body's production of free radicals, strengthen the arteries and heart, and reverse oxidation.</description>
    <arm_group_label>Coenzyme Q10 group</arm_group_label>
    <other_name>ubiquinone</other_name>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>placebo that looks and tastes identical to Coenzyme Q10</description>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult men and women&#xD;
&#xD;
          -  Elective cardiac surgery&#xD;
&#xD;
          -  Cardiac surgery on cardiopulmonary bypass&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant or planning on getting pregnant during the study&#xD;
&#xD;
          -  Emergency cardiac surgery&#xD;
&#xD;
          -  Contain a minimum of 2 traits of metabolic syndrome&#xD;
&#xD;
          -  Cardiac surgery without cardiopulmonary bypass&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 20, 2020</study_first_submitted>
  <study_first_submitted_qc>June 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 23, 2020</study_first_posted>
  <last_update_submitted>June 22, 2020</last_update_submitted>
  <last_update_submitted_qc>June 22, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 23, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Nanjing Medical University</investigator_affiliation>
    <investigator_full_name>Hong Liu</investigator_full_name>
    <investigator_title>Investigator of Cardio-Thoracic Surgery</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cardiovascular Diseases</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/NCT04444349
org study id: CoQ10-Jph 2020
nct id: NCT04444349
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Cardiovascular diseases are the leading causes of death and prescription drug use. Research
      on certain dietary supplements looks promising as a way to help reduce risk factors. Previous
      studies showed that CoQ10 levels were decreased in cardiovascular patients and worsening of
      mitochondrial dysfunction was observed. The overall objective of this study is to determine
      if supplementing with CoQ10 can reduce inflammatory risk factors in adults with cardiac
      surgery, independent of other dietary or physical activity changes.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Care Provider, Outcomes Assessor)
measure: C-reactive protein
time frame: Change from baseline of CRP in mg/L at 5 days after surgery.
description: Inflammatory and endothelial blood work biomarkers
measure: Interleukin-6
time frame: Change from baseline of IL-6 in pg/mL at 5 days after surgery.
description: Inflammatory and endothelial blood work biomarkers
arm group label: Coenzyme Q10 group
arm group type: Experimental
description: Participants in the experimental group will be given 10mg of Coenzyme Q10 each time (3 times a day).
arm group label: Control
arm group type: Sham Comparator
description: Participants in the experimental group will be given 10mg of placebo each time (3 times a day).
intervention type: Drug
intervention name: Coenzyme Q10
description: Coenzyme Q10 is a cardiovascular health supplement. It is a component of the electron transport chain and participates in aerobic cellular respiration, which generates energy in the form of ATP. The ingredients in Coenzyme Q10 help regulate the body's production of free radicals, strengthen the arteries and heart, and reverse oxidation.
arm group label: Coenzyme Q10 group
other name: ubiquinone
intervention type: Dietary Supplement
intervention name: Placebo
description: placebo that looks and tastes identical to Coenzyme Q10
arm group label: Control
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Nanjing Medical University
investigator full name: Hong Liu
investigator title: Investigator of Cardio-Thoracic Surgery
mesh term: Cardiovascular Diseases
mesh term: Ubiquinone
mesh term: Coenzyme Q10
sharing ipd: No