BurnPhase 2/3NCT01749371
Vitamin E Supplementation in Burned Patients
A Phase 2/3 study testing Vitamin E in people with Burn, run by The University of Texas Medical Branch, Galveston at 3 sites in United States.
Trial summary
A dietary antioxidant, alpha-tocopherol, will be used to potentially attenuate Vitamin E short- and long-term losses in plasma and adipose, reverse the oxidative stress of burn injury and, in the process, decrease the secondary consequences of burn injury, including lung injury and impaired wound healing. Read more about this study
- Who is it for?
- Ages 16 to 85 years
- Conditions the study is for
- Burn
- What is being tested?
- Vitamin E
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 3 sitesUnited States
- Study dates
- Feb 2013to Sep 2017
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 16 to 85 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age: 16 - 85 years
- ≥40% total body surface area burn
Who cannot join
- Septic shock
- Bleeding disorders
- Diabetes, or on diabetes medications or anti-lipidemic agents
- Arthritis
- Known kidney/renal disease, endocrine disease, cancer, heart disease, osteoporosis, liver disease
- Congestive heart failure
- Positive hepatitis or HIV screens
- Pregnancy (women)
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Texas Southwestern Medical Center, Parkland Health and Hospital System
Dallas, Texas, 75390
University of Texas Medical Branch: Blocker Burn Unit and Shriners Hospitals for Children
Galveston, Texas, 77555
Memorial Hermann Hospital Burn Intensive Care Unit
Houston, Texas, 77030
About this study
A dietary antioxidant, alpha-tocopherol, will be used to potentially attenuate Vitamin E short- and long-term losses in plasma and adipose, reverse the oxidative stress of burn injury and, in the process, decrease the secondary consequences of burn injury, including lung injury and impaired wound healing. This may improve the quality of life of the burn patient by preventing pathophysiology that may result from oxidative stress and may reduce hospital stay. Our research will lay the foundation for the future development of effective, safe, and economic therapeutic interventions to treat burn injury-associated metabolic abnormalities. Also, it will provide the basis for the development of supplemental regulations and pharmacotherapy to treat burn patients with vitamin E. The risks are very reasonable in relation to the anticipated benefits to our subjects because a) vitamin E is a simple vitamin that is abundant and approved for clinical use, and b) the subjects will be monitored consistently for the minimal increased tendency to bleed.
Read the detailed description
Please see above.
- Conditions
- Burn
- Being tested
- Vitamin E
- Keywords
- Alpha-Tocopherol, Inflammation, Oxidative Stress, Malondialdehyde, Isoprostanes, Lung Dysfunction, Wound Healing
- Medical subject headings
- Burns, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin EDrug
Also called dl-Alpha Tocopheryl, Alpha Tocopherol, Aqueous Vitamin E Oral Drops
1200 IU dl-alpha tocopheryl acetate after the initial excision surgery after admission (days 1-15 or days 16-30)
| Study group | Role | What they receive |
|---|---|---|
| Early Vitamin E | Experimental | Vitamin E is administered from Days 1-15 after the initial excision surgery after admission. Receives: Drug: Vitamin E |
| Delayed Vitamin E | Experimental | Vitamin E is administered from Days 16-30 after the initial excision surgery after admission. Receives: Drug: Vitamin E |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Assessed for Plasma Alpha- and Gamma-Tocopherol Levels
Number of participants who had plasma alpha- and gamma-tocopherol levels measured during the study.
Measured: Days 0-30
Secondary outcomes (3)
Number of Participants Completing Pulmonary Function Testing
Number of participants who completed pulmonary function testing during the study period.
Measured: Day 30
Number of Participants Assessed for Plasma and Urine Oxidative Stress and Vitamin E Metabolite Biomarkers
Number of participants with plasma and urine malondialdehyde, isoprostanes, and Vitamin E metabolites measured during the study.
Measured: Days 0-30
Number of Participants Assessed for Adipose Alpha- and Gamma-Tocopherol Concentrations
Number of participants with adipose tissue alpha- and gamma-tocopherol concentrations evaluated during the study.
Measured: Days 0-30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2012 (estimated)
- Study startFeb 2013
- Primary completionAug 2017
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for BurnStudies of the same condition, open and under way.
- 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
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Texas Medical Branch, Galveston
- Sponsor type
- University, hospital or other
- Collaborators
- Shriners Hospitals for Children, Memorial Hermann Hospital, University of Texas
- Responsible party
- Sponsor
- Investigators
- Perenlei Enkhbaatar, MD, PhD, Principal investigator, University of TexasLinda E Sousse, PhD, MBA, Study director, University of Texas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01749371
- Sponsor's protocol ID
- 12-189
- Status last verified
- Jun 2026
- First submitted
- 10 Dec 2012
- Last updated
- 20 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin E Supplementation in Burned Patients
- ClinicalTrials.gov ID
- NCT01749371
- Acronym / sponsor ID
- 12-189
- Conditions
- Burn
- Keywords
- Alpha-Tocopherol, Inflammation, Oxidative Stress, Malondialdehyde, Isoprostanes, Lung Dysfunction, Wound Healing
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- The University of Texas Medical Branch, GalvestonUniversity, hospital or other
- Collaborators
- Shriners Hospitals for Children, Memorial Hermann Hospital, University of Texas
- Study start
- Feb 2013 (actual)
- Primary completion
- Aug 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 13 Dec 2012 (estimated)
- Results
- Posted 20 Jul 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A dietary antioxidant, alpha-tocopherol, will be used to potentially attenuate Vitamin E short- and long-term losses in plasma and adipose, reverse the oxidative stress of burn injury and, in the process, decrease the secondary consequences of burn injury, including lung injury and impaired wound healing. This may improve the quality of life of the burn patient by preventing pathophysiology that may result from oxidative stress and may reduce hospital stay. Our research will lay the foundation for the future development of effective, safe, and economic therapeutic interventions to treat burn injury-associated metabolic abnormalities. Also, it will provide the basis for the development of supplemental regulations and pharmacotherapy to treat burn patients with vitamin E. The risks are very reasonable in relation to the anticipated benefits to our subjects because a) vitamin E is a simple vitamin that is abundant and approved for clinical use, and b) the subjects will be monitored consistently for the minimal increased tendency to bleed.
Detailed description
Please see above.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early Vitamin E | Experimental | Drug: Vitamin EVitamin E is administered from Days 1-15 after the initial excision surgery after admission. |
| Delayed Vitamin E | Experimental | Drug: Vitamin EVitamin E is administered from Days 16-30 after the initial excision surgery after admission. |
Who may qualify
- Ages
- 16 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Age: 16 - 85 years
- ≥40% total body surface area burn
Key exclusion criteria (8 listed)
- Septic shock
- Bleeding disorders
- Diabetes, or on diabetes medications or anti-lipidemic agents
- Arthritis
- Known kidney/renal disease, endocrine disease, cancer, heart disease, osteoporosis, liver disease
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 |
|---|---|---|
| Vitamin EAlso: dl-Alpha Tocopheryl, Alpha Tocopherol, Aqueous Vitamin E Oral Drops1200 IU dl-alpha tocopheryl acetate after the initial excision surgery after admission (days 1-15 or days 16-30) | Drug | Delayed Vitamin E, Early Vitamin E |
Primary outcome
Number of Participants Assessed for Plasma Alpha- and Gamma-Tocopherol Levels
Time frame: Days 0-30
Number of participants who had plasma alpha- and gamma-tocopherol levels measured during the study.
3 secondary outcomes
Number of Participants Completing Pulmonary Function Testing
Time frame: Day 30
Number of Participants Assessed for Plasma and Urine Oxidative Stress and Vitamin E Metabolite Biomarkers
Time frame: Days 0-30
Number of Participants Assessed for Adipose Alpha- and Gamma-Tocopherol Concentrations
Time frame: Days 0-30
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Perenlei Enkhbaatar, MD, PhD principal investigator
University of Texas
Linda E Sousse, PhD, MBA study director
University of Texas
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Vitamin E in people with Burn, run by The University of Texas Medical Branch, Galveston at 3 sites 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 2 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: finished, as of the sponsor's last update on 20 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Assessed for Plasma Alpha- and Gamma-Tocopherol Levels (time frame: Days 0-30). 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 20 Jul 2026.