Vitamin E Supplementation in Burned Patients

Burn Clinical Trial

Official title:

Vitamin E Supplementation in Burned Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01749371
• Other study ID #: 12-189
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: February 2013
• Est. completion date: September 2017

Study information

• Verified date: January 2019
• Source: The University of Texas Medical Branch, Galveston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Please see above.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: September 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 85 Years

Eligibility

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)

Related Conditions & MeSH terms

• Burn

Intervention

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

Locations

Country	Name	City	State
United States	University of Texas Southwestern Medical Center, Parkland Health and Hospital System	Dallas	Texas
United States	University of Texas Medical Branch: Blocker Burn Unit and Shriners Hospitals for Children	Galveston	Texas
United States	Memorial Hermann Hospital Burn Intensive Care Unit	Houston	Texas

Sponsors (4)

Lead Sponsor	Collaborator
The University of Texas Medical Branch, Galveston	Memorial Hermann Hospital, Shriners Hospitals for Children, University of Texas

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma Alpha- and Gamma-Tocopherol	Plasma measurements of alpha- and gamma-tocopherol as an indicator of antioxidant status	Days 0-30
Secondary	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
Secondary	Exercise Stress Test	Assessment of strength and cardiopulmonary function through use of exercise	Day 30
Secondary	Wound Healing	Assessment of variables of the wound such as redness and scar height	Days 0-30
Secondary	Plasma and Urine Malondialdehyde, Isoprostanes, Vitamin E Metabolites	Assessment of antioxidant and oxidant status in plasma (short-term)	Days 0-30
Secondary	Adipose Alpha- and Gamma-Tocopherol	Assessment of antioxidant and oxidant status in adipose (long-term)	Days 0-30