Recruiting
Early Phase 1

CoQ10

Sponsor:

Massachusetts General Hospital

Code:

NCT02251626

Conditions

Burn Injury

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

coenzyme Q10

Placebo

Study Details

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.

Conditions

Burn Injury

Study ID

NCT02251626

Start date

Apr, 2014

Status verified date

Sep, 2016

Completion date

Jun, 2017

Anticipated

Primary completion date

Apr, 2017

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Coenzyme Q10 (ubiquinol)

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

placebo comparator: Placebo for CoQ10 (ubiquinol)

Placebo group will be given placebo only

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.

Placebo

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

Primary outcome measure

  • Coenzyme Q10 Content in Peripheral Blood Mononuclear Cells [ Time Frame: up to four weeks ]
  • Plasma Coenzyme Q10 Concentration [ Time Frame: up to four weeks ]

Central Contacts and Locations

Central contacts

Masao Kaneki, MD, PhD

617-726-8122mkaneki@helix.mgh.harvard.edu

Jeremy Goverman, MD

617-726-3712JGOVERMAN@mgh.harvard.edu

Locations

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Masao Kaneki, MD, PhD

617-726-8122mkaneki@helix.mgh.harvard.edu

Jeremy Goverman, MD

617-726-3712JGOVERMAN@mgh.harvard.edu

Principal Investigator:

Masao Kaneki, MD. PhD

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Sep 15, 2016

Last verified

Sep, 2016

Keywords

  • MGH
  • Burn patient
  • Adult
  • CoQ10
  • Ubiquinol

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2016-09-15.