Assessing Bioavailability of CoQ10 Supplementation in Burn Patients
Status unconfirmed · Early Phase 1 · Has a placebo group
Conditions studied: Burn Injury
In brief
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.
Key facts
- Study ID
- NCT02251626
- Run by
- Massachusetts General Hospital
- People needed
- 50
- Starts
- 2014-04-01
- Expected to finish
- 2017-06-01
- Last updated by the study team
- 2016-09-15
Who can join
Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.
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)
Where it is running
- Massachusetts General Hospital — Boston, Massachusetts, United States (enrolling)
Full record on ClinicalTrials.gov
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