Vitamin E Supplementation in Burned Patients

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01749371

Enrollment

Registered

2012-12-13

Start date

2013-02-01

Completion date

2017-09-01

Last updated

2026-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Burn

Keywords

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

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.

Interventions

DRUGVitamin E

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

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

16 Years to 85 Years

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame	Description
Number of Participants Assessed for Plasma Alpha- and Gamma-Tocopherol Levels	Days 0-30	Number of participants who had plasma alpha- and gamma-tocopherol levels measured during the study.

Secondary

Measure	Time frame	Description
Number of Participants Completing Pulmonary Function Testing	Day 30	Number of participants who completed pulmonary function testing during the study period.
Number of Participants Assessed for Plasma and Urine Oxidative Stress and Vitamin E Metabolite Biomarkers	Days 0-30	Number of participants with plasma and urine malondialdehyde, isoprostanes, and Vitamin E metabolites measured during the study.
Number of Participants Assessed for Adipose Alpha- and Gamma-Tocopherol Concentrations	Days 0-30	Number of participants with adipose tissue alpha- and gamma-tocopherol concentrations evaluated during the study.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORPerenlei Enkhbaatar, MD, PhD

University of Texas

STUDY_DIRECTORLinda E Sousse, PhD, MBA