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OpenTrials
Completed

NCT Number: NCT01749371

Vitamin E Supplementation in Burned Patients

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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Key information

Age range

16 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

University of Texas Southwestern Medical Center, Parkland Health and Hospital System, Dallas, Texas, United States

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About this study

Please see above.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Vitamin E

Drug

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

Primary outcomes

  1. Number of Participants Assessed for Plasma Alpha- and Gamma-Tocopherol Levels

    Time frame: Days 0-30

    Number of participants who had plasma alpha- and gamma-tocopherol levels measured during the study.

Secondary outcomes

  1. Number of Participants Completing Pulmonary Function Testing

    Time frame: Day 30

    Number of participants who completed pulmonary function testing during the study period.

  2. Number of Participants Assessed for Plasma and Urine Oxidative Stress and Vitamin E Metabolite Biomarkers

    Time frame: Days 0-30

    Number of participants with plasma and urine malondialdehyde, isoprostanes, and Vitamin E metabolites measured during the study.

  3. Number of Participants Assessed for Adipose Alpha- and Gamma-Tocopherol Concentrations

    Time frame: Days 0-30

    Number of participants with adipose tissue alpha- and gamma-tocopherol concentrations evaluated during the study.

Other outcomes

  1. Wound Healing

    Time frame: Days 0-30

    Assessment of variables of the wound such as redness and scar height

  2. Exercise Stress Test

    Time frame: Day 30

    Assessment of strength and cardiopulmonary function through use of exercise

Sponsors and collaborators

Lead sponsor

The University of Texas Medical Branch, Galveston

Other

Collaborators

  • Memorial Hermann Hospital
  • Shriners Hospitals for Children
  • University of Texas

Registry information

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Dec 13, 2012
Registry last updated
Jul 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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