ClinicalTrials.gov
ClinicalTrials.gov Menu

Vitamin E Supplementation in Burned Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01749371
Recruitment Status : Completed
First Posted : December 13, 2012
Last Update Posted : February 22, 2018
Sponsor:
Collaborators:
Shriners Hospitals for Children
Memorial Hermann Hospital
University of Texas
Information provided by (Responsible Party):
The University of Texas Medical Branch, Galveston

Brief Summary:
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 or disease Intervention/treatment Phase
Burn Drug: Vitamin E Phase 2 Phase 3

Detailed Description:
Please see above.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Vitamin E Supplementation in Burned Patients
Actual Study Start Date : February 2013
Actual Primary Completion Date : August 2017
Actual Study Completion Date : September 2017


Arm Intervention/treatment
Experimental: Early Vitamin E
Vitamin E is administered from Days 1-15 after the initial excision surgery after admission.
Drug: Vitamin E
1200 IU dl-alpha tocopheryl acetate after the initial excision surgery after admission (days 1-15 or days 16-30)
Other Names:
  • 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
1200 IU dl-alpha tocopheryl acetate after the initial excision surgery after admission (days 1-15 or days 16-30)
Other Names:
  • dl-Alpha Tocopheryl
  • Alpha Tocopherol
  • Aqueous Vitamin E Oral Drops



Primary Outcome Measures :
  1. Plasma Alpha- and Gamma-Tocopherol [ Time Frame: Days 0-30 ]
    Plasma measurements of alpha- and gamma-tocopherol as an indicator of antioxidant status


Secondary Outcome Measures :
  1. Pulmonary Function Testing [ Time Frame: Day 30 ]
    Assessment of pulmonary function by measuring variables such as functional vital capacity of the lungs and volume ventilation in an effort-dependent exam

  2. Exercise Stress Test [ Time Frame: Day 30 ]
    Assessment of strength and cardiopulmonary function through use of exercise

  3. Wound Healing [ Time Frame: Days 0-30 ]
    Assessment of variables of the wound such as redness and scar height

  4. Plasma and Urine Malondialdehyde, Isoprostanes, Vitamin E Metabolites [ Time Frame: Days 0-30 ]
    Assessment of antioxidant and oxidant status in plasma (short-term)

  5. Adipose Alpha- and Gamma-Tocopherol [ Time Frame: Days 0-30 ]
    Assessment of antioxidant and oxidant status in adipose (long-term)



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   16 Years to 85 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01749371


Locations
United States, Texas
University of Texas Southwestern Medical Center, Parkland Health and Hospital System
Dallas, Texas, United States, 75390
University of Texas Medical Branch: Blocker Burn Unit and Shriners Hospitals for Children
Galveston, Texas, United States, 77555
Memorial Hermann Hospital Burn Intensive Care Unit
Houston, Texas, United States, 77030
Sponsors and Collaborators
The University of Texas Medical Branch, 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

Responsible Party: The University of Texas Medical Branch, Galveston
ClinicalTrials.gov Identifier: NCT01749371     History of Changes
Other Study ID Numbers: 12-189
First Posted: December 13, 2012    Key Record Dates
Last Update Posted: February 22, 2018
Last Verified: February 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

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

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