Vitamin E Supplementation in Burn Patients
Primary Purpose
Burn Injury
Status
Withdrawn
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
dl-alpha-tocopheryl acetate
Sponsored by
About this trial
This is an interventional treatment trial for Burn Injury focused on measuring Vitamin E, Burn, Oxidation, Lung Dysfunction, Fatty Liver, Lipid Peroxidation
Eligibility Criteria
Inclusion Criteria:
- Age: 6 months - 85 years
- >20% TBSA burn
Exclusion Criteria:
- Bleeding disorders
- Positive hepatitis or HIV screens
- Pregnancy (women)
Sites / Locations
- Shriners Hospitals for Children
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Vitamin E Treated
Untreated
Arm Description
Outcomes
Primary Outcome Measures
Alpha-Tocopherol in Plasma, Adipose (also: Lung, Skin, Muscle, Liver in the case of Death)
Gamma-Tocopherol in Plasma, Adipose (also: Lung, Skin, Muscle, Liver in the case of Death)
Vitamin E Metabolites in Plasma, Urine
Malondialdehyde in Plasma, Urine (also: Lung, Skin, Muscle in the case of Death)
Isoprostanes in Plasma, Urine (also: Lung, Skin, Muscle in the case of Death)
Lipid Panel in Plasma and Triglyceride Concentration
Liver Ultrasound
Pulmonary Function Study Variables
Cardiopulmonary Stress Test
Secondary Outcome Measures
Open Body Surface Area and Wound Healing
Weight
Basal Metabolic Rate
Diet History and Food Intake
Fluid Balance
Incidence of Acute Respiratory Distress Syndrome (ARDS)
Incidence of Pneumonia
Incidence of Atelectasis
Ventilator Variables (Compliance, Resistance, Work of Breathing, Number of Days Ventilated)
Pulmonary Status Variables (Spirometry, Blood Gas, Diffusion Constant, Pulmonary Capillary Surface Area)
Full Information
NCT ID
NCT01413620
First Posted
August 9, 2011
Last Updated
September 20, 2021
Sponsor
Shriners Hospitals for Children
Collaborators
University of Texas, Oregon State University
1. Study Identification
Unique Protocol Identification Number
NCT01413620
Brief Title
Vitamin E Supplementation in Burn Patients
Official Title
Vitamin E Supplementation in Burn Patients
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Withdrawn
Study Start Date
August 2011 (undefined)
Primary Completion Date
August 2017 (Anticipated)
Study Completion Date
August 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shriners Hospitals for Children
Collaborators
University of Texas, Oregon State University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burn Injury
Keywords
Vitamin E, Burn, Oxidation, Lung Dysfunction, Fatty Liver, Lipid Peroxidation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Vitamin E Treated
Arm Type
Experimental
Arm Title
Untreated
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
dl-alpha-tocopheryl acetate
Other Intervention Name(s)
Vitamin E, Aqueous Vitamin E Oral Drops, Silarx, No. 54838-0005-30
Intervention Description
Ages 6 months-1 year will receive 75 IU/day of dl-alpha-tocopheryl acetate, while ages 2-5 years will receive 150 IU/day. Ages 6-8 will receive 300 IU/day, while ages 9-13 will receive 600 IU/day, ages 14-17 will receive 800 IU/day, and ages 18-70 will receive 1200 IU/day. Vitamin E will be administered in a liquid or pill form. The dose of aqueous vitamin E (Aqueous Vitamin E Oral Drops, Silarx, No. 54838-0005-30, Spring Valley, NY) will be given orally. When/If the patient is able to eat independently, the dose of vitamin E may be given in a pill form (Novatol 5-57, No. 410217, Archer Daniels Midland Company, Decatur, IL). Depending on the subject's group, the supplement of vitamin E either will be given on days 1-15 of the study or days 16-30 of the study.
Primary Outcome Measure Information:
Title
Alpha-Tocopherol in Plasma, Adipose (also: Lung, Skin, Muscle, Liver in the case of Death)
Time Frame
30 Days
Title
Gamma-Tocopherol in Plasma, Adipose (also: Lung, Skin, Muscle, Liver in the case of Death)
Time Frame
30 Days
Title
Vitamin E Metabolites in Plasma, Urine
Time Frame
30 Days
Title
Malondialdehyde in Plasma, Urine (also: Lung, Skin, Muscle in the case of Death)
Time Frame
30 Days
Title
Isoprostanes in Plasma, Urine (also: Lung, Skin, Muscle in the case of Death)
Time Frame
30 Days
Title
Lipid Panel in Plasma and Triglyceride Concentration
Time Frame
30 Days
Title
Liver Ultrasound
Time Frame
30 Days
Title
Pulmonary Function Study Variables
Time Frame
30 Days
Title
Cardiopulmonary Stress Test
Time Frame
30 Days
Secondary Outcome Measure Information:
Title
Open Body Surface Area and Wound Healing
Time Frame
30 Days
Title
Weight
Time Frame
30 Days
Title
Basal Metabolic Rate
Time Frame
30 Days
Title
Diet History and Food Intake
Time Frame
30 Days
Title
Fluid Balance
Time Frame
30 Days
Title
Incidence of Acute Respiratory Distress Syndrome (ARDS)
Time Frame
30 Days
Title
Incidence of Pneumonia
Time Frame
30 Days
Title
Incidence of Atelectasis
Time Frame
30 Days
Title
Ventilator Variables (Compliance, Resistance, Work of Breathing, Number of Days Ventilated)
Time Frame
30 Days
Title
Pulmonary Status Variables (Spirometry, Blood Gas, Diffusion Constant, Pulmonary Capillary Surface Area)
Time Frame
30 Days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age: 6 months - 85 years
>20% TBSA burn
Exclusion Criteria:
Bleeding disorders
Positive hepatitis or HIV screens
Pregnancy (women)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jong O Lee, MD
Organizational Affiliation
University of Texas Medical Branch, Shriners Hospitals for Children
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hal K Hawkins, MD, PhD
Organizational Affiliation
University of Texas Medical Branch, Shriners Hospitals for Children
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Linda E Sousse, PhD, MBA
Organizational Affiliation
University of Texas Medical Branch, Shriners Hospitals for Children
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Daniel L Traber, PhD
Organizational Affiliation
University of Texas Medical Branch, Shriners Hospitals for Children
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Maret G Traber, PhD
Organizational Affiliation
Oregon State University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
David N Herndon, M.D.
Organizational Affiliation
University of Texas Medical Branch, Shriners Hospitals for Children
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Celeste C Finnerty, Ph.D.
Organizational Affiliation
University of Texas Medical Branch, Shriners Hospitals for Children
Official's Role
Study Director
Facility Information:
Facility Name
Shriners Hospitals for Children
City
Galveston
State/Province
Texas
ZIP/Postal Code
77555
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Vitamin E Supplementation in Burn Patients
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