NCT01749371

Vitamin E Supplementation in Burned Patients

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: The University of Texas Medical Branch, Galveston · Academic / Other
• Sex: All
• Age: 16 Years – 85 Years
• Healthy volunteers: Not accepted

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. 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.

Conditions

• Burn

Interventions

Type	Name	Description
DRUG	Vitamin E	1200 IU dl-alpha tocopheryl acetate after the initial excision surgery after admission (days 1-15 or days 16-30)

Timeline

• Start date: 2013-02-01
• Primary completion: 2017-08-01
• Completion: 2017-09-01
• First posted: 2012-12-13
• Last updated: 2019-01-18

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study