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.

Study Overview

• Status: Completed
• Conditions: Burn
• Intervention / Treatment: Drug: Vitamin E

Detailed Description

Please see above.

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75390
      • University of Texas Southwestern Medical Center, Parkland Health and Hospital System
    • Galveston, Texas, United States, 77555
      • University of Texas Medical Branch: Blocker Burn Unit and Shriners Hospitals for Children
    • Houston, Texas, United States, 77030
      • Memorial Hermann Hospital Burn Intensive Care Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 85 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Early Vitamin E; Vitamin E is administered from Days 1-15 after the initial excision surgery after admission.	Drug: Vitamin E; 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
Experimental: Delayed Vitamin E; Vitamin E is administered from Days 16-30 after the initial excision surgery after admission.	Drug: Vitamin E; 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: The University of Texas Medical Branch, Galveston
• Collaborators: University of Texas; Memorial Hermann Hospital; Shriners Hospitals for Children
• Investigators: Principal Investigator: Perenlei Enkhbaatar, MD, PhD, University of Texas; Study Director: Linda E Sousse, PhD, MBA, University of Texas

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2013
• Primary Completion (Actual): August 1, 2017
• Study Completion (Actual): September 1, 2017

Study Registration Dates

• First Submitted: December 10, 2012
• First Submitted That Met QC Criteria: December 11, 2012
• First Posted (Estimate): December 13, 2012

Study Record Updates

• Last Update Posted (Actual): January 18, 2019
• Last Update Submitted That Met QC Criteria: January 17, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: Inflammation; Alpha-Tocopherol; Oxidative Stress; Malondialdehyde; Isoprostanes; Lung Dysfunction; Wound Healing
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Protective Agents; Micronutrients; Antioxidants; Vitamin E; Tocopherols; alpha-Tocopherol; Vitamins; Tocotrienols
• Other Study ID Numbers: 12-189

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No