Vitamin E Supplementation in Burn Patients
- Registration Number
- NCT01413620
- Lead Sponsor
- Shriners Hospitals for Children
- Brief Summary
Burned patients because of their increased oxidative stress have severely depleted vitamin E, which is a dietary antioxidant. Oxidative stress is responsible for much of the pathophysiology seen in burned patients, which leads to acute and chronic morbidity and mortality, in addition to a decrease in their quality of life. Oral vitamin E will be used to reverse the oxidative stress of burn injury and, in the process, decrease the secondary consequences of thermal trauma. This proposal will demonstrate the benefit of maintaining adequate vitamin E status.
- Detailed Description
We have previously demonstrated that thermal injury depletes plasma vitamin E in pediatric burn patients. However, plasma changes reflect short-term vitamin E changes, whereas adipose tissue alpha-tocopherol concentrations reflect long-term vitamin E status. We reported last year that burn injury depleted vitamin E stores in adipose tissue in children by nearly half within one month following injury. Our long-term goal is to improve the quality of life of burn patients by preventing pulmonary and hepatic dysfunction that may occur from vitamin E depletion. The objectives of this application are to a) attenuate alpha-tocopherol depletion in burned patients by vitamin E supplementation, b) prevent or reverse oxidative stress in these patients, and c) collect pilot data on the effect of vitamin E supplementation on lung and liver function. Our central hypothesis is that the administration of high doses of alpha-tocopherol will prevent or restore levels of vitamin E in adipose tissue and reverse the oxidative state in burned patients. The rationale of the proposed studies is that in severe cases of vitamin E depletion, oxidative stress, fatty liver and lung dysfunction have all been reported in our patients. We will administer vitamin E supplements (300-1200 IU RRR-alpha-tocopherol) to burn subjects (n= 20 per group, 6-70 years, ≥20% total body surface burns) for fifteen days. The subjects will be randomly assigned into two groups: an early treatment group who will receive vitamin E for days 1-15 of the study, and a delayed treatment group who will receive vitamin E for days 16-30 of the study. Both groups will be studied for a total of thirty days. We will test the following aims: Aim 1: determine the degree that supplemental Vitamin E will attenuate alpha-tocopherol depletion. Aim 2: determine if supplemental Vitamin E reduces markers of oxidative stress in burned patients. Aim 3: collect preliminary data to establish the relationship between oxidative stress and pulmonary pathophysiology and fatty liver after burn injury. We will measure plasma and adipose tissue alpha-tocopherol and urinary and plasma markers of oxidative stress, prior to supplementation and then weekly. The proposed research is innovative because the oxidative stress of burn injury causes a severe depletion of an essential nutrient, vitamin E. Supplementation of vitamin E is a novel concept that may mitigate the complications of burns, including lung injury, fatty liver and peripheral neuropathy.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- Age: 6 months - 85 years
- >20% TBSA burn
- Bleeding disorders
- Positive hepatitis or HIV screens
- Pregnancy (women)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Vitamin E Treated dl-alpha-tocopheryl acetate -
- Primary Outcome Measures
Name Time Method Gamma-Tocopherol in Plasma, Adipose (also: Lung, Skin, Muscle, Liver in the case of Death) 30 Days Alpha-Tocopherol in Plasma, Adipose (also: Lung, Skin, Muscle, Liver in the case of Death) 30 Days Vitamin E Metabolites in Plasma, Urine 30 Days Isoprostanes in Plasma, Urine (also: Lung, Skin, Muscle in the case of Death) 30 Days Malondialdehyde in Plasma, Urine (also: Lung, Skin, Muscle in the case of Death) 30 Days Lipid Panel in Plasma and Triglyceride Concentration 30 Days Liver Ultrasound 30 Days Pulmonary Function Study Variables 30 Days Cardiopulmonary Stress Test 30 Days
- Secondary Outcome Measures
Name Time Method Basal Metabolic Rate 30 Days Diet History and Food Intake 30 Days Fluid Balance 30 Days Open Body Surface Area and Wound Healing 30 Days Weight 30 Days Incidence of Acute Respiratory Distress Syndrome (ARDS) 30 Days Incidence of Pneumonia 30 Days Incidence of Atelectasis 30 Days Ventilator Variables (Compliance, Resistance, Work of Breathing, Number of Days Ventilated) 30 Days Pulmonary Status Variables (Spirometry, Blood Gas, Diffusion Constant, Pulmonary Capillary Surface Area) 30 Days
Trial Locations
- Locations (1)
Shriners Hospitals for Children
🇺🇸Galveston, Texas, United States