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Vitamin E Supplementation in Burned Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by The University of Texas, Galveston
Sponsor:
Collaborators:
Shriners Hospitals for Children
Memorial Hermann Hospital
University of Texas
Information provided by (Responsible Party):
The University of Texas, Galveston
ClinicalTrials.gov Identifier:
NCT01749371
First received: December 10, 2012
Last updated: June 5, 2014
Last verified: June 2014
  Purpose

A dietary antioxidant, alpha-tocopherol, will be used to potentially attenuate Vitamin E short- and long-term losses in plasma and adipose, reverse the oxidative stress of burn injury and, in the process, decrease the secondary consequences of burn injury, including lung injury and impaired wound healing. This may improve the quality of life of the burn patient by preventing pathophysiology that may result from oxidative stress and may reduce hospital stay. Our research will lay the foundation for the future development of effective, safe, and economic therapeutic interventions to treat burn injury-associated metabolic abnormalities. Also, it will provide the basis for the development of supplemental regulations and pharmacotherapy to treat burn patients with vitamin E. The risks are very reasonable in relation to the anticipated benefits to our subjects because a) vitamin E is a simple vitamin that is abundant and approved for clinical use, and b) the subjects will be monitored consistently for the minimal increased tendency to bleed.


Condition Intervention Phase
Burn
Drug: Vitamin E (dl-Alpha Tocopheryl)
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Vitamin E Supplementation in Burned Patients

Resource links provided by NLM:


Further study details as provided by The University of Texas, Galveston:

Primary Outcome Measures:
  • Plasma Alpha- and Gamma-Tocopherol [ Time Frame: Days 0-30 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Pulmonary Function Testing [ Time Frame: Day 30 ] [ Designated as safety issue: No ]
  • Exercise Stress Test [ Time Frame: Day 30 ] [ Designated as safety issue: No ]
  • Wound Healing [ Time Frame: Days 0-30 ] [ Designated as safety issue: No ]
  • Plasma and Urine Malondialdehyde, Isoprostanes, Vitamin E Metabolites [ Time Frame: Days 0-30 ] [ Designated as safety issue: No ]
  • Adipose Alpha- and Gamma-Tocopherol [ Time Frame: Days 0-30 ] [ Designated as safety issue: No ]

Estimated Enrollment: 42
Study Start Date: February 2013
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Early Vitamin E
Vitamin E is administered from Days 1-15 after the initial excision surgery after admission.
Drug: Vitamin E (dl-Alpha Tocopheryl)
Other Names:
  • Vitamin E
  • dl-Alpha Tocopheryl
  • Alpha Tocopherol
  • Aqueous Vitamin E Oral Drops
Experimental: Delayed Vitamin E
Vitamin E is administered from Days 16-30 after the initial excision surgery after admission.
Drug: Vitamin E (dl-Alpha Tocopheryl)
Other Names:
  • Vitamin E
  • dl-Alpha Tocopheryl
  • Alpha Tocopherol
  • Aqueous Vitamin E Oral Drops

  Eligibility

Ages Eligible for Study:   16 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age: 16 - 85 years
  • ≥40% total body surface area burn

Exclusion Criteria:

  • Septic shock
  • Bleeding disorders
  • Diabetes, or on diabetes medications or anti-lipidemic agents
  • Arthritis
  • Known kidney/renal disease, endocrine disease, cancer, heart disease, osteoporosis, liver disease
  • Congestive heart failure
  • Positive hepatitis or HIV screens
  • Pregnancy (women)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01749371

Contacts
Contact: Linda E Sousse, PhD, MBA 3617285536 lesousse@utmb.edu
Contact: Perenlei Enkhbaatar, MD, PhD 4097470096 peenkhba@utmb.edu

Locations
United States, Texas
University of Texas Southwestern Medical Center, Parkland Health and Hospital System Not yet recruiting
Dallas, Texas, United States, 75390
Contact: Steven E Wolf, MD    214-648-2041    steven.wolf@utsouthwestern.edu   
Contact: Agnes Burris, RN    2146483521    agnes.burris@utsouthwestern.edu   
Principal Investigator: Steven Wolf, MD         
Sub-Investigator: John Hunt, MD         
Sub-Investigator: Brett Arnoldo, MD         
University of Texas Medical Branch: Blocker Burn Unit and Shriners Hospitals for Children Recruiting
Galveston, Texas, United States, 77555
Contact: Perenlei Enkhbaatar, MD, PhD    409-747-0096    peenkhba@utmb.edu   
Contact: Linda E Sousse, PhD, MBA    3617285536    lesousse@utmb.edu   
Principal Investigator: Perenlei Enkhbaatar, MD, PhD         
Sub-Investigator: Hal K Hawkins, MD, PhD         
Sub-Investigator: Jong O Lee, MD         
Sub-Investigator: Linda E Sousse, PhD, MBA         
Sub-Investigator: David N Herndon, MD         
Sub-Investigator: Kristofer Jennings, PhD         
Sub-Investigator: Celeste C Finnerty, PhD         
Sub-Investigator: Ronald P Mlcak, PhD, MBA         
Memorial Hermann Hospital Burn Intensive Care Unit Recruiting
Houston, Texas, United States, 77030
Contact: James M Cross, MD    713-500-6407    James.M.Cross@uth.tmc.edu   
Contact: Jeanette M Podbielski, RN    7135006407    Jeanette.M.Podbielski@uth.tmc.edu   
Principal Investigator: James M Cross, MD         
Sub-Investigator: Todd Huzar, MD         
Sub-Investigator: Charles Wade, PhD         
Sponsors and Collaborators
The University of Texas, Galveston
Shriners Hospitals for Children
Memorial Hermann Hospital
University of Texas
Investigators
Principal Investigator: Perenlei Enkhbaatar, MD, PhD University of Texas
Study Director: Linda E Sousse, PhD, MBA University of Texas
  More Information

No publications provided

Responsible Party: The University of Texas, Galveston
ClinicalTrials.gov Identifier: NCT01749371     History of Changes
Other Study ID Numbers: 12-189
Study First Received: December 10, 2012
Last Updated: June 5, 2014
Health Authority: United States: Food and Drug Administration
United States: Federal Government

Keywords provided by The University of Texas, Galveston:
Alpha-Tocopherol
Gamma-Tocopherol
Inflammation
Oxidative Stress
Malondialdehyde
Isoprostanes
Lung Dysfunction
Wound Healing

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

ClinicalTrials.gov processed this record on November 19, 2014