Vitamin E Supplementation in Burned Patients

NCT01749371 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: 12-189
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Burn

Keywords

Alpha-Tocopherol; Inflammation; Oxidative Stress; Malondialdehyde; Isoprostanes; Lung Dysfunction; Wound Healing

Outcome Measures

Primary Outcomes (1)

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

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

  Days 0-30

Secondary Outcomes (3)

• Number of Participants Completing Pulmonary Function Testing

  Day 30

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

  Days 0-30

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

  Days 0-30

Other Outcomes (2)

• Wound Healing

  Days 0-30

• Exercise Stress Test

  Day 30

Study Arms (2)

Early Vitamin E

EXPERIMENTAL

Vitamin E is administered from Days 1-15 after the initial excision surgery after admission.

Drug: Vitamin E

Delayed Vitamin E

EXPERIMENTAL

Vitamin E is administered from Days 16-30 after the initial excision surgery after admission.

Drug: Vitamin E

Interventions

Vitamin E DRUG

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

Also known as: dl-Alpha Tocopheryl, Alpha Tocopherol, Aqueous Vitamin E Oral Drops

Delayed Vitamin E; Early Vitamin E

Eligibility Criteria

• Age: 16 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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)

Sponsors & Collaborators

• The University of Texas Medical Branch, Galveston: lead
• Shriners Hospitals for Children: collaborator
• Memorial Hermann Hospital: collaborator
• University of Texas: collaborator

Study Sites (3)

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

Dallas, Texas, 75390, United States

Location

University of Texas Medical Branch: Blocker Burn Unit and Shriners Hospitals for Children

Galveston, Texas, 77555, United States

Location

Memorial Hermann Hospital Burn Intensive Care Unit

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Burns; Inflammation

Interventions

Vitamin E; alpha-tocopheryl nicotinate; alpha-Tocopherol

Condition Hierarchy (Ancestors)

Wounds and Injuries; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Tocopherols

Results Point of Contact

• Title: Dr. Perenlei Enkhbaatar
• Organization: University of Texas Medical Branch Galveston

peenkhba@utmb.edu

409-747-0096

Study Officials

• Perenlei Enkhbaatar, MD, PhD

  University of Texas

  PRINCIPAL INVESTIGATOR

• Linda E Sousse, PhD, MBA

  University of Texas

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2012
• First Posted: December 13, 2012
• Study Start: February 1, 2013
• Primary Completion: August 1, 2017
• Study Completion: September 1, 2017
• Last Updated: July 20, 2026
• Results First Posted: July 20, 2026

Record last verified: 2026-06

Locations

US (3)