Assessing Bioavailability of CoQ10 Supplementation in Burn Patients (CoQ10)

Assessing Bioavailability and Effects of Ubiquinol Supplementation on Biomarkers of Mitochondrial Function/Integrity, Metabolic Dysfunction, and Circulating Alarmins in Burn Patients

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.

Study Overview

• Status: Unknown
• Conditions: Burn Injury
• Intervention / Treatment: Dietary supplement: coenzyme Q10; Dietary supplement: Placebo

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Recruiting
      • Massachusetts General Hospital
      • Contact: Masao Kaneki, MD, PhD; Phone Number: 617-726-8122; Email: mkaneki@helix.mgh.harvard.edu
      • Contact: Jeremy Goverman, MD; Phone Number: 617-726-3712; Email: JGOVERMAN@mgh.harvard.edu
      • Principal Investigator: Masao Kaneki, MD. PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Ages eligible for study: 18 years and older, and below 85 yeas old
• Burn patients with 5% or greater of total body surface area burn
• Nutrition support: routine oral and/or enteral nutrition
• Enrolled within one week after burn injury
• Patient or guardian who is capable of giving full informed consent.
• Anticipated stay in the MGH Burn Unit: 5 days or more

Exclusion Criteria:

• < 5% TBSA burn
• Patients required full parenteral nutrition without oral or enteral nutrition support.
• Patients with liver disease (bilirubin greater than 3)
• Patients with thyroid disorders (thyroid disease which currently require treatment)
• Patients with malignancy under treatment
• Patients with mental illness who have impaired decision-making capacity (Mental illness defined by the presence of psychotropic medications and/or the diagnosis of psychiatric illness at the time of admission.) Patients with mental illness can be included unless it is determined by the psychiatrist covering the burn unit that they are unable to consent for themselves for other aspects of their care and treatment.)
• Patients with HIV*
• Pregnancy (as determined by routine admission labs)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Coenzyme Q10 (ubiquinol); Coenzyme Q10 (ubiquinol) group will be given 1,800 mg coenzyme Q10 (ubiquinol) per day	Dietary supplement: coenzyme Q10; It is a randomized and double blind study so patients or his/her doctor will not know which group s/he is in.; Other Names: Ubiquinol supplement
Placebo Comparator: Placebo for CoQ10 (ubiquinol); Placebo group will be given placebo only	Dietary supplement: Placebo; It is a randomized and double blind study so patients or his/her doctor will not know which group s/he is in.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Coenzyme Q10 Content in Peripheral Blood Mononuclear Cells	up to four weeks
Plasma Coenzyme Q10 Concentration	up to four weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Plasma Mitochondrial DNA Concentration	up to four weeks
Plasma cytokine concentrations	up to four weeks

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: Kaneka Medical America LLC
• Investigators: Principal Investigator: Masao Kaneki, MD, PhD, Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (Anticipated): April 1, 2017
• Study Completion (Anticipated): June 1, 2017

Study Registration Dates

• First Submitted: September 20, 2014
• First Submitted That Met QC Criteria: September 25, 2014
• First Posted (Estimate): September 29, 2014

Study Record Updates

• Last Update Posted (Estimate): September 15, 2016
• Last Update Submitted That Met QC Criteria: September 13, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Keywords: Adult; CoQ10; MGH; Burn patient; Ubiquinol
• Additional Relevant MeSH Terms: Wounds and Injuries; Burns; Physiological Effects of Drugs; Micronutrients; Vitamins; Coenzyme Q10; Ubiquinone
• Other Study ID Numbers: 2013P001111

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No