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| Name | Class |
|---|---|
| Shriners Hospitals for Children | OTHER |
| Memorial Hermann Hospital | OTHER |
| University of Texas | OTHER |
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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.
Please see above.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Early Vitamin E | Experimental | Vitamin E is administered from Days 1-15 after the initial excision surgery after admission. |
|
| Delayed Vitamin E | Experimental | Vitamin E is administered from Days 16-30 after the initial excision surgery after admission. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin E | Drug | 1200 IU dl-alpha tocopheryl acetate after the initial excision surgery after admission (days 1-15 or days 16-30) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Plasma Alpha- and Gamma-Tocopherol | Plasma measurements of alpha- and gamma-tocopherol as an indicator of antioxidant status | Days 0-30 |
| Measure | Description | Time Frame |
|---|---|---|
| Pulmonary Function Testing | Assessment of pulmonary function by measuring variables such as functional vital capacity of the lungs and volume ventilation in an effort-dependent exam | Day 30 |
| Exercise Stress Test |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Perenlei Enkhbaatar, MD, PhD | University of Texas | Principal Investigator |
| Linda E Sousse, PhD, MBA | University of Texas | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas Southwestern Medical Center, Parkland Health and Hospital System | Dallas | Texas | 75390 | United States | ||
| Type | Date | Date Unknown |
|---|---|---|
| Release | Jun 15, 2023 | |
| Reset | Jul 3, 2023 | |
| Release | Mar 27, 2026 | |
| Reset | Apr 16, 2026 | |
| Release | May 22, 2026 | |
| Reset | Jun 18, 2026 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 15, 2023 | Jul 3, 2023 | |||
| Mar 27, 2026 |
| ID | Term |
|---|---|
| D002056 | Burns |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D014810 | Vitamin E |
| C012581 | alpha-tocopheryl nicotinate |
| D024502 | alpha-Tocopherol |
| ID | Term |
|---|---|
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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|
Assessment of strength and cardiopulmonary function through use of exercise
| Day 30 |
| Wound Healing | Assessment of variables of the wound such as redness and scar height | Days 0-30 |
| Plasma and Urine Malondialdehyde, Isoprostanes, Vitamin E Metabolites | Assessment of antioxidant and oxidant status in plasma (short-term) | Days 0-30 |
| Adipose Alpha- and Gamma-Tocopherol | Assessment of antioxidant and oxidant status in adipose (long-term) | Days 0-30 |
| University of Texas Medical Branch: Blocker Burn Unit and Shriners Hospitals for Children |
| Galveston |
| Texas |
| 77555 |
| United States |
| Memorial Hermann Hospital Burn Intensive Care Unit | Houston | Texas | 77030 | United States |
| Apr 16, 2026 |
| May 22, 2026 | Jun 18, 2026 |
| Jun 22, 2026 |
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D024505 | Tocopherols |