Assessing Bioavailability of CoQ10 Supplementation in Burn Patients

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.

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)