Vitamin E Supplementation in Burned Patients

NCT ID: NCT01749371

Last Updated: 2019-01-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-02-28
• Study Completion Date: 2017-09-30

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.

Conditions

Burn

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Early Vitamin E

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

Group Type: EXPERIMENTAL

Vitamin E

Intervention Type: DRUG

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

Delayed Vitamin E

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

Group Type: EXPERIMENTAL

Vitamin E

Intervention Type: DRUG

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

Interventions

Vitamin E

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

Intervention Type: DRUG

Other Intervention Names

dl-Alpha Tocopheryl; Alpha Tocopherol; Aqueous Vitamin E Oral Drops

Eligibility Criteria

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)

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shriners Hospitals for Children

OTHER

Sponsor Role: collaborator

Memorial Hermann Hospital

OTHER

Sponsor Role: collaborator

University of Texas

OTHER

Sponsor Role: collaborator

The University of Texas Medical Branch, Galveston

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Perenlei Enkhbaatar, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Texas

Linda E Sousse, PhD, MBA

Role: STUDY_DIRECTOR

University of Texas

Locations

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, United States

Countries

United States

Other Identifiers

12-189

Identifier Type: -

Identifier Source: org_study_id