Vitamin E
Drug1200 IU dl-alpha tocopheryl acetate after the initial excision surgery after admission (days 1-15 or days 16-30)
Other names: dl-Alpha Tocopheryl, Alpha Tocopherol, Aqueous Vitamin E Oral Drops
NCT Number: NCT01749371
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.
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Notify Me16 year–85 year
All sexes
Interventional
Phase 2 / Phase 3
University of Texas Southwestern Medical Center, Parkland Health and Hospital System, Dallas, Texas, United States
Please see above.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
1200 IU dl-alpha tocopheryl acetate after the initial excision surgery after admission (days 1-15 or days 16-30)
Other names: dl-Alpha Tocopheryl, Alpha Tocopherol, Aqueous Vitamin E Oral Drops
Time frame: Days 0-30
Number of participants who had plasma alpha- and gamma-tocopherol levels measured during the study.
Time frame: Day 30
Number of participants who completed pulmonary function testing during the study period.
Time frame: Days 0-30
Number of participants with plasma and urine malondialdehyde, isoprostanes, and Vitamin E metabolites measured during the study.
Time frame: Days 0-30
Number of participants with adipose tissue alpha- and gamma-tocopherol concentrations evaluated during the study.
Time frame: Days 0-30
Assessment of variables of the wound such as redness and scar height
Time frame: Day 30
Assessment of strength and cardiopulmonary function through use of exercise
The University of Texas Medical Branch, Galveston
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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