Clinical trial NCT01749371: Vitamin E Supplementation in Burned Patients
Official title: Vitamin E Supplementation in Burned Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Burn
Keywords: Alpha-Tocopherol
Inflammation
Oxidative Stress
Malondialdehyde
Isoprostanes
Lung Dysfunction
Wound Healing
Lead sponsor: The University of Texas Medical Branch, Galveston
Sponsor class: OTHER
Collaborators: name: Shriners Hospitals for Children
name: Memorial Hermann Hospital
name: University of Texas
First posted: 2012-12-13
Enrollment: 31
Sex: ALL
Minimum age (years): 16
Maximum age (years): 85
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Plasma Alpha- and Gamma-Tocopherol
timeFrame: Days 0-30
Secondary outcomes:
measure: Pulmonary Function Testing
timeFrame: Day 30
measure: Exercise Stress Test
timeFrame: Day 30
measure: Wound Healing
timeFrame: Days 0-30
measure: Plasma and Urine Malondialdehyde, Isoprostanes, Vitamin E Metabolites
timeFrame: Days 0-30
measure: Adipose Alpha- and Gamma-Tocopherol
timeFrame: Days 0-30
Other outcomes:
Locations:
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center, Parkland Health and Hospital System
state: Texas
city: Galveston
country: United States
facility: University of Texas Medical Branch: Blocker Burn Unit and Shriners Hospitals for Children
state: Texas
city: Houston
country: United States
facility: Memorial Hermann Hospital Burn Intensive Care Unit
state: Texas
Study officials:
affiliation: University of Texas
name: Perenlei Enkhbaatar, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Texas
name: Linda E Sousse, PhD, MBA
role: STUDY_DIRECTOR
References: