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Vitamin E Supplementation in Burn Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by Shriners Hospitals for Children.
Recruitment status was  Recruiting
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

August 9, 2011
March 10, 2012
August 2011
August 2014   (final data collection date for primary outcome measure)
  • 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 ]
  • Alpha-Tocopherol in Plasma, Adipose (also: Lung, Skin, Muscle, Liver in the case of Death) [ Time Frame: 28 Days ] [ Designated as safety issue: No ]
  • Gamma-Tocopherol in Plasma, Adipose (also: Lung, Skin, Muscle, Liver in the case of Death) [ Time Frame: 28 Days ] [ Designated as safety issue: No ]
  • Vitamin E Metabolites in Plasma, Urine [ Time Frame: 28 Days ] [ Designated as safety issue: No ]
  • Malondialdehyde in Plasma, Urine (also: Lung, Skin, Muscle in the case of Death) [ Time Frame: 28 Days ] [ Designated as safety issue: No ]
  • Isoprostanes in Plasma, Urine (also: Lung, Skin, Muscle in the case of Death) [ Time Frame: 28 Days ] [ Designated as safety issue: No ]
  • Triglyceride Concentration [ Time Frame: 28 Days ] [ Designated as safety issue: No ]
  • Lipid Panel in Plasma [ Time Frame: 28 Days ] [ Designated as safety issue: No ]
  • Pulmonary Function Study Variables [ Time Frame: 28 Days ] [ Designated as safety issue: No ]
  • Cardiopulmonary Stress Test [ Time Frame: 28 Days ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01413620 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Open Body Surface Area [ Time Frame: 28 Days ] [ Designated as safety issue: No ]
  • Weight [ Time Frame: 28 Days ] [ Designated as safety issue: No ]
  • Basal Metabolic Rate [ Time Frame: 28 Days ] [ Designated as safety issue: No ]
  • Diet History and Food Intake [ Time Frame: 28 Days ] [ Designated as safety issue: No ]
  • Fluid Balance [ Time Frame: 28 Days ] [ Designated as safety issue: No ]
  • Incidence of Acute Respiratory Distress Syndrome (ARDS) [ Time Frame: 28 Days ] [ Designated as safety issue: No ]
  • Incidence of Pneumonia [ Time Frame: 28 Days ] [ Designated as safety issue: No ]
  • Incidence of Atelectasis [ Time Frame: 28 Days ] [ Designated as safety issue: No ]
  • Ventilator Variables (Compliance, Resistance, Work of Breathing, Number of Days Ventilated) [ Time Frame: 28 Days ] [ Designated as safety issue: No ]
  • Pulmonary Status Variables (Spirometry, Blood Gas, Diffusion Constant, Pulmonary Capillary Surface Area) [ Time Frame: 28 Days ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Vitamin E Supplementation in Burn Patients
Vitamin E Supplementation in Burn Patients

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.

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Burn Injury
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
  • Experimental: Vitamin E Treated
    Intervention: Dietary Supplement: dl-alpha-tocopheryl acetate
  • No Intervention: Untreated
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
August 2014
August 2014   (final data collection date for primary outcome measure)

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)
Both
6 Years to 70 Years
No
Contact: Jong O Lee, MD (409) 770-6731 jolee@utmb.edu
Contact: Linda E Sousse, PhD, MBA (409) 772-6458 lesousse@utmb.edu
United States
 
NCT01413620
VitE2011
Yes
Jong O. Lee, Shriners Hospitals for Children
Shriners Hospitals for Children
  • University of Texas
  • Oregon State University
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
Shriners Hospitals for Children
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP