Vitamin E Supplementation in Burn Patients

Summary

Burned patients because of their increased oxidative stress have severely depleted vitamin E, which is a dietary antioxidant. Oxidative stress is responsible for much of the pathophysiology seen in burned patients, which leads to acute and chronic morbidity and mortality, in addition to a decrease in their quality of life. Oral vitamin E will be used to reverse the oxidative stress of burn injury and, in the process, decrease the secondary consequences of thermal trauma. This proposal will demonstrate the benefit of maintaining adequate vitamin E status.

Conditions

• Burn Injury

Interventions

DRUG

dl-alpha-tocopheryl acetate

Ages 6 months-1 year will receive 75 IU/day of dl-alpha-tocopheryl acetate, while ages 2-5 years will receive 150 IU/day. Ages 6-8 will receive 300 IU/day, while ages 9-13 will receive 600 IU/day, ages 14-17 will receive 800 IU/day, and ages 18-70 will receive 1200 IU/day. Vitamin E will be administered in a liquid or pill form. The dose of aqueous vitamin E (Aqueous Vitamin E Oral Drops, Silarx, No. 54838-0005-30, Spring Valley, NY) will be given orally. When/If the patient is able to eat independently, the dose of vitamin E may be given in a pill form (Novatol 5-57, No. 410217, Archer Daniels Midland Company, Decatur, IL). Depending on the subject's group, the supplement of vitamin E either will be given on days 1-15 of the study or days 16-30 of the study.

Sponsors & Collaborators

• University of Texas

  collaborator OTHER

• Oregon State University

  collaborator OTHER

• Shriners Hospitals for Children

  lead OTHER

Principal Investigators

• Jong O Lee, MD · University of Texas Medical Branch, Shriners Hospitals for Children

• Hal K Hawkins, MD, PhD · University of Texas Medical Branch, Shriners Hospitals for Children

• Linda E Sousse, PhD, MBA · University of Texas Medical Branch, Shriners Hospitals for Children

• Daniel L Traber, PhD · University of Texas Medical Branch, Shriners Hospitals for Children

• Maret G Traber, PhD · Oregon State University

• David N Herndon, M.D. · University of Texas Medical Branch, Shriners Hospitals for Children

• Celeste C Finnerty, Ph.D. · University of Texas Medical Branch, Shriners Hospitals for Children

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

6 Months

Max Age

85 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-08-31

Primary Completion

2017-08-31

Completion

2021-08-31

Countries

• United States

Study Locations