NCT02251626

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P50-P75 for early_phase_1

Timeline
Completed

Started Apr 2014

Typical duration for early_phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 20, 2014

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 29, 2014

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

September 15, 2016

Status Verified

September 1, 2016

Enrollment Period

3 years

First QC Date

September 20, 2014

Last Update Submit

September 13, 2016

Conditions

Burn Injury

Keywords

MGHBurn patientAdultCoQ10Ubiquinol

Outcome Measures

Primary Outcomes (2)

  • Coenzyme Q10 Content in Peripheral Blood Mononuclear Cells

    up to four weeks

  • Plasma Coenzyme Q10 Concentration

    up to four weeks

Secondary Outcomes (2)

  • Plasma Mitochondrial DNA Concentration

    up to four weeks

  • Plasma cytokine concentrations

    up to four weeks

Study Arms (2)

Coenzyme Q10 (ubiquinol)

EXPERIMENTAL

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

Dietary Supplement: coenzyme Q10

Placebo for CoQ10 (ubiquinol)

PLACEBO COMPARATOR

Placebo group will be given placebo only

Dietary Supplement: Placebo

Interventions

coenzyme Q10DIETARY_SUPPLEMENT

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

Also known as: Ubiquinol supplement
Coenzyme Q10 (ubiquinol)
PlaceboDIETARY_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)

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • \< 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

MeSH Terms

Conditions

Burns

Interventions

coenzyme Q10

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

  • Masao Kaneki, MD, PhD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Masao Kaneki, MD, PhD

CONTACT

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

Jeremy Goverman, MD

CONTACT

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

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor/Associate Biochemist, Department of Anesthesia,Critical Care and Pain Medicine

Study Record Dates

First Submitted

September 20, 2014

First Posted

September 29, 2014

Study Start

April 1, 2014

Primary Completion

April 1, 2017

Study Completion

June 1, 2017

Last Updated

September 15, 2016

Record last verified: 2016-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)