Vitamin E Supplementation in Burn Patients

This study is currently recruiting participants.
Verified March 2012 by Shriners Hospitals for Children
Sponsor:
Collaborators:
University of Texas
Oregon State University
Information provided by (Responsible Party):
Jong O. Lee, Shriners Hospitals for Children
ClinicalTrials.gov Identifier:
NCT01413620
First received: August 9, 2011
Last updated: March 10, 2012
Last verified: March 2012
  Purpose

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.


Condition Intervention Phase
Burn Injury
Dietary Supplement: dl-alpha-tocopheryl acetate
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Vitamin E Supplementation in Burn Patients

Resource links provided by NLM:


Further study details as provided by Shriners Hospitals for Children:

Primary Outcome Measures:
  • Alpha-Tocopherol in Plasma, Adipose (also: Lung, Skin, Muscle, Liver in the case of Death) [ Time Frame: 30 Days ] [ Designated as safety issue: No ]
  • Gamma-Tocopherol in Plasma, Adipose (also: Lung, Skin, Muscle, Liver in the case of Death) [ Time Frame: 30 Days ] [ Designated as safety issue: No ]
  • Vitamin E Metabolites in Plasma, Urine [ Time Frame: 30 Days ] [ Designated as safety issue: No ]
  • Malondialdehyde in Plasma, Urine (also: Lung, Skin, Muscle in the case of Death) [ Time Frame: 30 Days ] [ Designated as safety issue: No ]
  • Isoprostanes in Plasma, Urine (also: Lung, Skin, Muscle in the case of Death) [ Time Frame: 30 Days ] [ Designated as safety issue: No ]
  • Lipid Panel in Plasma and Triglyceride Concentration [ Time Frame: 30 Days ] [ Designated as safety issue: No ]
  • Liver Ultrasound [ Time Frame: 30 Days ] [ Designated as safety issue: No ]
  • Pulmonary Function Study Variables [ Time Frame: 30 Days ] [ Designated as safety issue: No ]
  • Cardiopulmonary Stress Test [ Time Frame: 30 Days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Open Body Surface Area and Wound Healing [ Time Frame: 30 Days ] [ Designated as safety issue: No ]
  • Weight [ Time Frame: 30 Days ] [ Designated as safety issue: No ]
  • Basal Metabolic Rate [ Time Frame: 30 Days ] [ Designated as safety issue: No ]
  • Diet History and Food Intake [ Time Frame: 30 Days ] [ Designated as safety issue: No ]
  • Fluid Balance [ Time Frame: 30 Days ] [ Designated as safety issue: No ]
  • Incidence of Acute Respiratory Distress Syndrome (ARDS) [ Time Frame: 30 Days ] [ Designated as safety issue: No ]
  • Incidence of Pneumonia [ Time Frame: 30 Days ] [ Designated as safety issue: No ]
  • Incidence of Atelectasis [ Time Frame: 30 Days ] [ Designated as safety issue: No ]
  • Ventilator Variables (Compliance, Resistance, Work of Breathing, Number of Days Ventilated) [ Time Frame: 30 Days ] [ Designated as safety issue: No ]
  • Pulmonary Status Variables (Spirometry, Blood Gas, Diffusion Constant, Pulmonary Capillary Surface Area) [ Time Frame: 30 Days ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: August 2011
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vitamin E Treated Dietary Supplement: dl-alpha-tocopheryl acetate
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
No Intervention: Untreated

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

Ages Eligible for Study:   6 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age: 6 - 70 years
  • >20% TBSA burn

Exclusion Criteria:

  • Septic shock
  • Bleeding disorders
  • Diabetes, or on diabetes medications or anti-lipidemic agents
  • Known liver disease, other than hepatic steatosis
  • Kidney/renal disease, endocrine disease, cancer, heart disease, osteoporosis
  • Congestive heart failure
  • Alcohol abuse (>20 g/day; CAGE questionnaire) or drug abuse (amphetamines, cocaine, opioids, marijuana)
  • Positive hepatitis or HIV screens
  • Pregnancy (women)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01413620

Contacts
Contact: Jong O Lee, MD (409) 770-6731 jolee@utmb.edu
Contact: Linda E Sousse, PhD, MBA (409) 772-6458 lesousse@utmb.edu

Locations
United States, Texas
Shriners Hospitals for Children Recruiting
Galveston, Texas, United States, 77555
Contact: Linda E Sousse, Ph.D., M.B.A.    (409) 772-6458    lesousse@UTMB.EDU   
Contact: Deb Benjamin, RN    (409) 772-3622    dbenjami@UTMB.EDU   
Principal Investigator: Jong O Lee, MD         
Sponsors and Collaborators
Shriners Hospitals for Children
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: Labros S Sidossis, 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
  More Information

No publications provided

Responsible Party: Jong O. Lee, Assistant Professor of Surgery and Faculty Surgeon, Shriners Hospitals for Children
ClinicalTrials.gov Identifier: NCT01413620     History of Changes
Other Study ID Numbers: VitE2011
Study First Received: August 9, 2011
Last Updated: March 10, 2012
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration
United States: Shriners Hospitals for Children

Keywords provided by Shriners Hospitals for Children:
Vitamin E
Burn
Oxidation
Lung Dysfunction
Fatty Liver
Lipid Peroxidation

Additional relevant MeSH terms:
Burns
Wounds and Injuries
Vitamin E
Alpha-Tocopherol
Tocopherols
Tocotrienols
Vitamins
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on April 16, 2014