Vitamin E Supplementation in Burn Patients

• ClinicalTrials.gov Identifier: NCT01413620
• Recruitment Status: Withdrawn
• First Posted: August 10, 2011
• Last Update Posted: September 21, 2021
• Sponsor: Shriners Hospitals for Children
• Collaborators: University of Texas; Oregon State University
• Information provided by (Responsible Party): Jong O. Lee, Shriners Hospitals for Children

Tracking Information

• First Submitted Date: August 9, 2011
• First Posted Date: August 10, 2011
• Last Update Posted Date: September 21, 2021
• Study Start Date: August 2011
• Estimated Primary Completion Date: August 2017 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 10, 2012)

• Alpha-Tocopherol in Plasma, Adipose (also: Lung, Skin, Muscle, Liver in the case of Death) [ Time Frame: 30 Days ]
• Gamma-Tocopherol in Plasma, Adipose (also: Lung, Skin, Muscle, Liver in the case of Death) [ Time Frame: 30 Days ]
• Vitamin E Metabolites in Plasma, Urine [ Time Frame: 30 Days ]
• Malondialdehyde in Plasma, Urine (also: Lung, Skin, Muscle in the case of Death) [ Time Frame: 30 Days ]
• Isoprostanes in Plasma, Urine (also: Lung, Skin, Muscle in the case of Death) [ Time Frame: 30 Days ]
• Lipid Panel in Plasma and Triglyceride Concentration [ Time Frame: 30 Days ]
• Liver Ultrasound [ Time Frame: 30 Days ]
• Pulmonary Function Study Variables [ Time Frame: 30 Days ]
• Cardiopulmonary Stress Test [ Time Frame: 30 Days ]

Original Primary Outcome Measures (submitted: August 9, 2011)

• Alpha-Tocopherol in Plasma, Adipose (also: Lung, Skin, Muscle, Liver in the case of Death) [ Time Frame: 28 Days ]
• Gamma-Tocopherol in Plasma, Adipose (also: Lung, Skin, Muscle, Liver in the case of Death) [ Time Frame: 28 Days ]
• Vitamin E Metabolites in Plasma, Urine [ Time Frame: 28 Days ]
• Malondialdehyde in Plasma, Urine (also: Lung, Skin, Muscle in the case of Death) [ Time Frame: 28 Days ]
• Isoprostanes in Plasma, Urine (also: Lung, Skin, Muscle in the case of Death) [ Time Frame: 28 Days ]
• Lipid Panel in Plasma [ Time Frame: 28 Days ]
• Triglyceride Concentration [ Time Frame: 28 Days ]
• Pulmonary Function Study Variables [ Time Frame: 28 Days ]
• Cardiopulmonary Stress Test [ Time Frame: 28 Days ]

Current Secondary Outcome Measures (submitted: March 10, 2012)

• Open Body Surface Area and Wound Healing [ Time Frame: 30 Days ]
• Weight [ Time Frame: 30 Days ]
• Basal Metabolic Rate [ Time Frame: 30 Days ]
• Diet History and Food Intake [ Time Frame: 30 Days ]
• Fluid Balance [ Time Frame: 30 Days ]
• Incidence of Acute Respiratory Distress Syndrome (ARDS) [ Time Frame: 30 Days ]
• Incidence of Pneumonia [ Time Frame: 30 Days ]
• Incidence of Atelectasis [ Time Frame: 30 Days ]
• Ventilator Variables (Compliance, Resistance, Work of Breathing, Number of Days Ventilated) [ Time Frame: 30 Days ]
• Pulmonary Status Variables (Spirometry, Blood Gas, Diffusion Constant, Pulmonary Capillary Surface Area) [ Time Frame: 30 Days ]

Original Secondary Outcome Measures (submitted: August 9, 2011)

• Open Body Surface Area [ Time Frame: 28 Days ]
• Weight [ Time Frame: 28 Days ]
• Basal Metabolic Rate [ Time Frame: 28 Days ]
• Diet History and Food Intake [ Time Frame: 28 Days ]
• Fluid Balance [ Time Frame: 28 Days ]
• Incidence of Acute Respiratory Distress Syndrome (ARDS) [ Time Frame: 28 Days ]
• Incidence of Pneumonia [ Time Frame: 28 Days ]
• Incidence of Atelectasis [ Time Frame: 28 Days ]
• Ventilator Variables (Compliance, Resistance, Work of Breathing, Number of Days Ventilated) [ Time Frame: 28 Days ]
• Pulmonary Status Variables (Spirometry, Blood Gas, Diffusion Constant, Pulmonary Capillary Surface Area) [ Time Frame: 28 Days ]

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Vitamin E Supplementation in Burn Patients
• Official Title: Vitamin E Supplementation in Burn Patients
• 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.
• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Participant); Primary Purpose: Treatment
• Condition: Burn Injury

Intervention

Drug: dl-alpha-tocopheryl acetate

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.

Other Names:

• Vitamin E
• Aqueous Vitamin E Oral Drops, Silarx, No. 54838-0005-30

Study Arms

• Experimental: Vitamin E Treated
  Intervention: Drug: dl-alpha-tocopheryl acetate
• No Intervention: Untreated

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Withdrawn
• Actual Enrollment (submitted: September 20, 2021): 0
• Original Estimated Enrollment (submitted: August 9, 2011): 60
• Estimated Study Completion Date: August 2021
• Estimated Primary Completion Date: August 2017 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 6 Months to 85 Years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01413620
• Other Study ID Numbers: VitE2011
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Jong O. Lee, Shriners Hospitals for Children
• Original Responsible Party: Jong Lee, Assistant Professor of Surgery, Shriners Hospitals for Children
• Current Study Sponsor: Shriners Hospitals for Children
• Original Study Sponsor: Same as current

Collaborators

• University of Texas
• Oregon State University

Investigators

• Principal Investigator: Jong O Lee, MD; University of Texas Medical Branch, Shriners Hospitals for Children
• Study Director: Hal K Hawkins, MD, PhD; University of Texas Medical Branch, Shriners Hospitals for Children
• Study Director: Linda E Sousse, PhD, MBA; University of Texas Medical Branch, Shriners Hospitals for Children
• Study Director: Daniel L Traber, PhD; University of Texas Medical Branch, Shriners Hospitals for Children
• Study Director: Maret G Traber, PhD; Oregon State University
• Study Director: David N Herndon, M.D.; University of Texas Medical Branch, Shriners Hospitals for Children
• Study Director: Celeste C Finnerty, Ph.D.; University of Texas Medical Branch, Shriners Hospitals for Children

• PRS Account: Shriners Hospitals for Children
• Verification Date: September 2021