Vitamin E Supplementation in Burned Patients

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: August 2017

Detailed Description

Please see above.

Interventions

  • Drug: Vitamin E
    • 1200 IU dl-alpha tocopheryl acetate after the initial excision surgery after admission (days 1-15 or days 16-30)

Arms, Groups and Cohorts

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

Clinical Trial Outcome Measures

Primary Measures

  • Plasma Alpha- and Gamma-Tocopherol
    • Time Frame: Days 0-30
    • Plasma measurements of alpha- and gamma-tocopherol as an indicator of antioxidant status

Secondary Measures

  • Pulmonary Function Testing
    • Time Frame: Day 30
    • Assessment of pulmonary function by measuring variables such as functional vital capacity of the lungs and volume ventilation in an effort-dependent exam
  • Exercise Stress Test
    • Time Frame: Day 30
    • Assessment of strength and cardiopulmonary function through use of exercise
  • Wound Healing
    • Time Frame: Days 0-30
    • Assessment of variables of the wound such as redness and scar height
  • Plasma and Urine Malondialdehyde, Isoprostanes, Vitamin E Metabolites
    • Time Frame: Days 0-30
    • Assessment of antioxidant and oxidant status in plasma (short-term)
  • Adipose Alpha- and Gamma-Tocopherol
    • Time Frame: Days 0-30
    • Assessment of antioxidant and oxidant status in adipose (long-term)

Participating in This Clinical Trial

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)

Gender Eligibility: All

Minimum Age: 16 Years

Maximum Age: 85 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • The University of Texas Medical Branch, Galveston
  • Collaborator
    • Shriners Hospitals for Children
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Perenlei Enkhbaatar, MD, PhD, Principal Investigator, University of Texas
    • Linda E Sousse, PhD, MBA, Study Director, University of Texas

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.