Status:
UNKNOWN
Assessing Bioavailability of CoQ10 Supplementation in Burn Patients
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
Kaneka Medical America LLC
Conditions:
Burn Injury
Eligibility:
All Genders
18-85 years
Phase:
EARLY_PHASE1
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...
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 coenz...
Eligibility Criteria
Inclusion
- 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
- \< 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)
Key Trial Info
Start Date :
April 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2017
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT02251626
Start Date
April 1 2014
End Date
June 1 2017
Last Update
September 15 2016
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114