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Vitamin E Supplementation in Burned Patients

The University of Texas System (UT) logo

The University of Texas System (UT)

Status and phase

Completed
Phase 3
Phase 2

Conditions

Burn

Treatments

Drug: Vitamin E

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Full description

Please see above.

Enrollment

31 patients

Sex

All

Ages

16 to 85 years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

31 participants in 2 patient groups

Early Vitamin E
Experimental group
Description:
Vitamin E is administered from Days 1-15 after the initial excision surgery after admission.
Treatment:
Drug: Vitamin E
Delayed Vitamin E
Experimental group
Description:
Vitamin E is administered from Days 16-30 after the initial excision surgery after admission.
Treatment:
Drug: Vitamin E

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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