Vitamin E Supplementation in Burned Patients

Completed · Phase 2/Phase 3

Conditions studied: Burn

In brief

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.

Key facts

Study ID

NCT01749371

Run by

The University of Texas Medical Branch, Galveston

People needed

27

Starts

2013-02-01

Expected to finish

2017-09-01

Last updated by the study team

2026-07-20

Who can join

Age: 16 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age: 16 - 85 years
• ≥40% total body surface area burn

You may not qualify if…

• 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)

Where it is running

• University of Texas Southwestern Medical Center, Parkland Health and Hospital System — Dallas, Texas, United States
• University of Texas Medical Branch: Blocker Burn Unit and Shriners Hospitals for Children — Galveston, Texas, United States
• Memorial Hermann Hospital Burn Intensive Care Unit — Houston, Texas, United States

Full record on ClinicalTrials.gov

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