Vitamin E Supplementation in Burned Patients

Phase 2

Completed

• Conditions: Burn
• Interventions: Drug: Vitamin E

• Registration Number: NCT01749371
• Lead Sponsor: The University of Texas Medical Branch, Galveston

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.

Detailed Description

Please see above.

Study Timeline

• Study First Submitted: 2012-12-10
• Study First Submitted QC: 2012-12-11
• Study First Posted: 2012-12-13
• Study Start: 2013-02
• Primary Completion: 2017-08
• Study Completion: 2017-09
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-17
• Last Update Posted: 2019-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Early Vitamin E	Vitamin E	Vitamin E is administered from Days 1-15 after the initial excision surgery after admission.
Delayed Vitamin E	Vitamin E	Vitamin E is administered from Days 16-30 after the initial excision surgery after admission.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Exercise Stress Test	Day 30	Assessment of strength and cardiopulmonary function through use of exercise
Wound Healing	Days 0-30	Assessment of variables of the wound such as redness and scar height
Plasma and Urine Malondialdehyde, Isoprostanes, Vitamin E Metabolites	Days 0-30	Assessment of antioxidant and oxidant status in plasma (short-term)
Adipose Alpha- and Gamma-Tocopherol	Days 0-30	Assessment of antioxidant and oxidant status in adipose (long-term)
Pulmonary Function Testing	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

Trial Locations

Locations (3)

University of Texas Southwestern Medical Center, Parkland Health and Hospital System; 🇺🇸 Dallas, Texas, United States

Memorial Hermann Hospital Burn Intensive Care Unit; 🇺🇸 Houston, Texas, United States

University of Texas Medical Branch: Blocker Burn Unit and Shriners Hospitals for Children; 🇺🇸 Galveston, Texas, United States