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Completed
NCT01749371
Vitamin E Supplementation in Burned Patients
Conditions: Burn
Sex: All
Ages: 16 Years – 85 Years
Healthy volunteers: No
Phase: PHASE2, PHASE3
Enrollment: 27
Sponsor: The University of Texas Medical Branch, Galveston
Location: University of Texas Southwestern Medical Center, Parkland Health and Hospital System Dallas Texas
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.
Eligibility Criteria
Inclusion Criteria:
* Age: 16 - 85 years
* ≥40% total body surface area burn
Exclusion Criteria:
* 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)
Source: ClinicalTrials.gov (NCT01749371). StuddyBuddy aggregates publicly available trial information.