Assessing Bioavailability of CoQ10 Supplementation in Burn Patients

Burn Injury Clinical Trial

— CoQ10  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02251626
• Other study ID #: 2013P001111
• Status: Recruiting
• Phase: Phase 0
• First received: September 20, 2014
• Last updated: September 13, 2016
• Start date: April 2014
• Est. completion date: June 2017

Study information

• Verified date: September 2016
• Source: Massachusetts General Hospital
• Contact: Masao Kaneki, MD, PhD
• Phone: 617-726-8122
• Email: mkaneki[@]helix.mgh.harvard.edu
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: June 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Burn Injury
• Burns

Intervention

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.
• Placebo
It is a randomized and double blind study so patients or his/her doctor will not know which group s/he is in.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Kaneka Pharma America LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Coenzyme Q10 Content in Peripheral Blood Mononuclear Cells		up to four weeks	No
Primary	Plasma Coenzyme Q10 Concentration		up to four weeks	No
Secondary	Plasma Mitochondrial DNA Concentration		up to four weeks	No
Secondary	Plasma cytokine concentrations		up to four weeks	No