Clinical trial NCT02251626: Assessing Bioavailability of CoQ10 Supplementation in Burn Patients
Official title: Assessing Bioavailability and Effects of Ubiquinol Supplementation on Biomarkers of Mitochondrial Function/Integrity, Metabolic Dysfunction, and Circulating Alarmins in Burn Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Burn Injury
Keywords: MGH
Burn patient
Adult
CoQ10
Ubiquinol
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Kaneka Medical America LLC
First posted: 2014-09-29
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Coenzyme Q10 Content in Peripheral Blood Mononuclear Cells
timeFrame: up to four weeks
measure: Plasma Coenzyme Q10 Concentration
timeFrame: up to four weeks
Secondary outcomes:
measure: Plasma Mitochondrial DNA Concentration
timeFrame: up to four weeks
measure: Plasma cytokine concentrations
timeFrame: up to four weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Masao Kaneki, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: