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| Name | Class |
|---|---|
| Kaneka Medical America LLC | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Coenzyme Q10 (ubiquinol) | Experimental | Coenzyme Q10 (ubiquinol) group will be given 1,800 mg coenzyme Q10 (ubiquinol) per day |
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| Placebo for CoQ10 (ubiquinol) | Placebo Comparator | Placebo group will be given placebo only |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| coenzyme Q10 | 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| Coenzyme Q10 Content in Peripheral Blood Mononuclear Cells | up to four weeks | |
| Plasma Coenzyme Q10 Concentration | up to four weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma Mitochondrial DNA Concentration | up to four weeks | |
| Plasma cytokine concentrations | up to four weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Masao Kaneki, MD, PhD | Contact | 617-726-8122 | mkaneki@helix.mgh.harvard.edu | |
| Jeremy Goverman, MD | Contact | 617-726-3712 | JGOVERMAN@mgh.harvard.edu |
| Name | Affiliation | Role |
|---|---|---|
| Masao Kaneki, MD, PhD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Recruiting | Boston | Massachusetts | 02114 | United States |
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| ID | Term |
|---|---|
| D002056 | Burns |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| C024989 | coenzyme Q10 |
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| Placebo | 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. |
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