Clinical trial NCT01413620: Vitamin E Supplementation in Burn Patients
Official title: Vitamin E Supplementation in Burn Patients
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Burn Injury
Keywords: Vitamin E
Burn
Oxidation
Lung Dysfunction
Fatty Liver
Lipid Peroxidation
Lead sponsor: Shriners Hospitals for Children
Sponsor class: OTHER
Collaborators: name: University of Texas
name: Oregon State University
First posted: 2011-08-10
Enrollment: 0
Sex: ALL
Minimum age (years): 6
Maximum age (years): 85
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* Age: 6 months - 85 years
* \>20% TBSA burn

Exclusion Criteria:

* Bleeding disorders
* Positive hepatitis or HIV screens
* Pregnancy (women)

Primary outcomes:
measure: Alpha-Tocopherol in Plasma, Adipose (also: Lung, Skin, Muscle, Liver in the case of Death)
timeFrame: 30 Days
measure: Gamma-Tocopherol in Plasma, Adipose (also: Lung, Skin, Muscle, Liver in the case of Death)
timeFrame: 30 Days
measure: Vitamin E Metabolites in Plasma, Urine
timeFrame: 30 Days
measure: Malondialdehyde in Plasma, Urine (also: Lung, Skin, Muscle in the case of Death)
timeFrame: 30 Days
measure: Isoprostanes in Plasma, Urine (also: Lung, Skin, Muscle in the case of Death)
timeFrame: 30 Days
measure: Lipid Panel in Plasma and Triglyceride Concentration
timeFrame: 30 Days
measure: Liver Ultrasound
timeFrame: 30 Days
measure: Pulmonary Function Study Variables
timeFrame: 30 Days
measure: Cardiopulmonary Stress Test
timeFrame: 30 Days
Secondary outcomes:
measure: Open Body Surface Area and Wound Healing
timeFrame: 30 Days
measure: Weight
timeFrame: 30 Days
measure: Basal Metabolic Rate
timeFrame: 30 Days
measure: Diet History and Food Intake
timeFrame: 30 Days
measure: Fluid Balance
timeFrame: 30 Days
measure: Incidence of Acute Respiratory Distress Syndrome (ARDS)
timeFrame: 30 Days
measure: Incidence of Pneumonia
timeFrame: 30 Days
measure: Incidence of Atelectasis
timeFrame: 30 Days
measure: Ventilator Variables (Compliance, Resistance, Work of Breathing, Number of Days Ventilated)
timeFrame: 30 Days
measure: Pulmonary Status Variables (Spirometry, Blood Gas, Diffusion Constant, Pulmonary Capillary Surface Area)
timeFrame: 30 Days
Other outcomes:
Locations:
city: Galveston
country: United States
facility: Shriners Hospitals for Children
state: Texas
Study officials:
affiliation: University of Texas Medical Branch, Shriners Hospitals for Children
name: Jong O Lee, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Texas Medical Branch, Shriners Hospitals for Children
name: Hal K Hawkins, MD, PhD
role: STUDY_DIRECTOR
affiliation: University of Texas Medical Branch, Shriners Hospitals for Children
name: Linda E Sousse, PhD, MBA
role: STUDY_DIRECTOR
affiliation: University of Texas Medical Branch, Shriners Hospitals for Children
name: Daniel L Traber, PhD
role: STUDY_DIRECTOR
affiliation: Oregon State University
name: Maret G Traber, PhD
role: STUDY_DIRECTOR
affiliation: University of Texas Medical Branch, Shriners Hospitals for Children
name: David N Herndon, M.D.
role: STUDY_DIRECTOR
affiliation: University of Texas Medical Branch, Shriners Hospitals for Children
name: Celeste C Finnerty, Ph.D.
role: STUDY_DIRECTOR
References: