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Vitamin E Supplementation in Burned Patients

NCT01749371 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2019-01-18

No results posted yet for this study

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.

Conditions

  • Burn

Interventions

DRUG

Vitamin E

1200 IU dl-alpha tocopheryl acetate after the initial excision surgery after admission (days 1-15 or days 16-30)

Sponsors & Collaborators

  • Shriners Hospitals for Children

    collaborator OTHER

  • Memorial Hermann Hospital

    collaborator OTHER

  • University of Texas

    collaborator OTHER

  • The University of Texas Medical Branch, Galveston

    lead OTHER

Principal Investigators

  • Perenlei Enkhbaatar, MD, PhD · University of Texas

  • Linda E Sousse, PhD, MBA · University of Texas

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
16 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-02-28
Primary Completion
2017-08-31
Completion
2017-09-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01749371 on ClinicalTrials.gov