Burn InjuryEarly Phase 1CoQ10NCT02251626
Assessing Bioavailability of CoQ10 Supplementation in Burn Patients
A Early Phase 1 study testing coenzyme Q10 in people with Burn Injury, run by Massachusetts General Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Burn Injury
- What is being tested?
- coenzyme Q10
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2014to Jun 2017
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- < 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)
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
Masao Kaneki, MD, PhD, 617-726-8122, mkaneki@helix.mgh.harvard.edu
Jeremy Goverman, MD, 617-726-3712, JGOVERMAN@mgh.harvard.edu
About this study
Official title: Assessing Bioavailability and Effects of Ubiquinol Supplementation on Biomarkers of Mitochondrial Function/Integrity, Metabolic Dysfunction, and Circulating Alarmins in Burn Patients
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.
Read the 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 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.
- Conditions
- Burn Injury
- Being tested
- coenzyme Q10, Placebo
- Keywords
- MGH, Burn patient, Adult, CoQ10, Ubiquinol
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
coenzyme Q10Dietary supplement
Also called Ubiquinol supplement
It is a randomized and double blind study so patients or his/her doctor will not know which group s/he is in.
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.
| Study group | Role | What they receive |
|---|---|---|
| Coenzyme Q10 (ubiquinol) | Experimental | Coenzyme Q10 (ubiquinol) group will be given 1,800 mg coenzyme Q10 (ubiquinol) per day Receives: Dietary Supplement: coenzyme Q10 |
| Placebo for CoQ10 (ubiquinol) | Placebo comparator | Placebo group will be given placebo only Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Coenzyme Q10 Content in Peripheral Blood Mononuclear Cells
Measured: up to four weeks
Plasma Coenzyme Q10 Concentration
Measured: up to four weeks
Secondary outcomes (2)
Plasma Mitochondrial DNA Concentration
Measured: up to four weeks
Plasma cytokine concentrations
Measured: up to four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2014 (estimated)
- Study startApr 2014
- Primary completionApr 2017 (estimated)
- Study completionJun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Burn InjuryStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Kaneka Medical America LLC
- Responsible party
- Principal investigator, Masao Kaneki, Massachusetts General Hospital
- Investigators
- Masao Kaneki, MD, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02251626
- Sponsor's protocol ID
- 2013P001111
- Acronym
- CoQ10
- Status last verified
- Sep 2016
- First submitted
- 20 Sep 2014
- Last updated
- 15 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Bioavailability and Effects of Ubiquinol Supplementation on Biomarkers of Mitochondrial Function/Integrity, Metabolic Dysfunction, and Circulating Alarmins in Burn Patients
- ClinicalTrials.gov ID
- NCT02251626
- Acronym / sponsor ID
- CoQ10 / 2013P001111
- Conditions
- Burn Injury
- Keywords
- MGH, Burn patient, Adult, CoQ10, Ubiquinol
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Kaneka Medical America LLC
- Study start
- Apr 2014
- Primary completion
- Apr 2017 (estimated)
- Study completion
- Jun 2017 (estimated)
- First posted
- 29 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Coenzyme Q10 (ubiquinol) | Experimental | Dietary Supplement: coenzyme Q10Coenzyme Q10 (ubiquinol) group will be given 1,800 mg coenzyme Q10 (ubiquinol) per day |
| Placebo for CoQ10 (ubiquinol) | Placebo comparator | Dietary Supplement: PlaceboPlacebo group will be given placebo only |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (8 listed)
- < 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| coenzyme Q10Also: Ubiquinol supplementIt is a randomized and double blind study so patients or his/her doctor will not know which group s/he is in. | Dietary supplement | Coenzyme Q10 (ubiquinol) |
| PlaceboIt is a randomized and double blind study so patients or his/her doctor will not know which group s/he is in. | Dietary supplement | Placebo for CoQ10 (ubiquinol) |
Primary outcome
Coenzyme Q10 Content in Peripheral Blood Mononuclear Cells
Time frame: up to four weeks
Plasma Coenzyme Q10 Concentration
Time frame: up to four weeks
2 secondary outcomes
Plasma Mitochondrial DNA Concentration
Time frame: up to four weeks
Plasma cytokine concentrations
Time frame: up to four weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Masao Kaneki, MD, PhD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing coenzyme Q10 in people with Burn Injury, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Masao Kaneki, MD, PhD (617-726-8122, mkaneki@helix.mgh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Coenzyme Q10 Content in Peripheral Blood Mononuclear Cells (time frame: up to four weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2016.