Assessing Bioavailability of CoQ10 Supplementation in Burn Patients

NCT ID: NCT02251626

Last Updated: 2016-09-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-04-30
• Study Completion Date: 2017-06-30

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.

Conditions

Burn Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: QUADRUPLE

Study Groups

Coenzyme Q10 (ubiquinol)

Coenzyme Q10 (ubiquinol) group will be given 1,800 mg coenzyme Q10 (ubiquinol) per day

Group Type: EXPERIMENTAL

coenzyme Q10

Intervention Type: DIETARY_SUPPLEMENT

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

Placebo for CoQ10 (ubiquinol)

Placebo group will be given placebo only

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

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.

Intervention Type: 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.

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Ubiquinol supplement

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kaneka Medical America LLC

INDUSTRY

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Masao Kaneki

Associate Professor/Associate Biochemist, Department of Anesthesia,Critical Care and Pain Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Masao Kaneki, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Masao Kaneki, MD, PhD

Role: CONTACT

mkaneki@helix.mgh.harvard.edu

617-726-8122

Jeremy Goverman, MD

Role: CONTACT

JGOVERMAN@mgh.harvard.edu

617-726-3712

Facility Contacts

Masao Kaneki, MD, PhD

Role: primary

mkaneki@helix.mgh.harvard.edu

617-726-8122

Jeremy Goverman, MD

Role: backup

JGOVERMAN@mgh.harvard.edu

617-726-3712

Other Identifiers

2013P001111

Identifier Type: -

Identifier Source: org_study_id