Vitamin E Supplementation in Burned Patients

Study Overview
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Brief Summary
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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
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Please see above.

Official Title
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Vitamin E Supplementation in Burned Patients

Conditions
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Burn

Intervention / Treatment
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* Drug: Vitamin E


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Early Vitamin E<br>Vitamin E is administered from Days 1-15 after the initial excision surgery after admission. | Drug: Vitamin E<br>* 1200 IU dl-alpha tocopheryl acetate after the initial excision surgery after admission (days 1-15 or days 16-30)<br>* Other names: Aqueous Vitamin E Oral Drops;|
| Experimental: Delayed Vitamin E<br>Vitamin E is administered from Days 16-30 after the initial excision surgery after admission. | Drug: Vitamin E<br>* 1200 IU dl-alpha tocopheryl acetate after the initial excision surgery after admission (days 1-15 or days 16-30)<br>* Other names: Aqueous Vitamin E Oral Drops;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma Alpha- and Gamma-Tocopherol | Plasma measurements of alpha- and gamma-tocopherol as an indicator of antioxidant status | Days 0-30 | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Alpha-Tocopherol, Inflammation, Oxidative Stress, Malondialdehyde, Isoprostanes, Lung Dysfunction, Wound Healing