NCT01749371

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Feb 2013

Typical duration for phase_2

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 10, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 13, 2012

Completed
2 months until next milestone

Study Start

First participant enrolled

February 1, 2013

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

January 18, 2019

Status Verified

January 1, 2019

Enrollment Period

4.5 years

First QC Date

December 10, 2012

Last Update Submit

January 17, 2019

Conditions

Burn

Keywords

Alpha-TocopherolInflammationOxidative StressMalondialdehydeIsoprostanesLung DysfunctionWound Healing

Outcome Measures

Primary Outcomes (1)

  • Plasma Alpha- and Gamma-Tocopherol

    Plasma measurements of alpha- and gamma-tocopherol as an indicator of antioxidant status

    Days 0-30

Secondary Outcomes (5)

  • Pulmonary Function Testing

    Day 30

  • Exercise Stress Test

    Day 30

  • Wound Healing

    Days 0-30

  • Plasma and Urine Malondialdehyde, Isoprostanes, Vitamin E Metabolites

    Days 0-30

  • Adipose Alpha- and Gamma-Tocopherol

    Days 0-30

Study Arms (2)

Early Vitamin E

EXPERIMENTAL

Vitamin E is administered from Days 1-15 after the initial excision surgery after admission.

Drug: Vitamin E

Delayed Vitamin E

EXPERIMENTAL

Vitamin E is administered from Days 16-30 after the initial excision surgery after admission.

Drug: Vitamin E

Interventions

Vitamin EDRUG

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

Also known as: dl-Alpha Tocopheryl, Alpha Tocopherol, Aqueous Vitamin E Oral Drops
Delayed Vitamin EEarly Vitamin E

Eligibility Criteria

Age16 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University of Texas Southwestern Medical Center, Parkland Health and Hospital System

Dallas, Texas, 75390, United States

Location

University of Texas Medical Branch: Blocker Burn Unit and Shriners Hospitals for Children

Galveston, Texas, 77555, United States

Location

Memorial Hermann Hospital Burn Intensive Care Unit

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

BurnsInflammation

Interventions

Vitamin Ealpha-tocopheryl nicotinatealpha-Tocopherol

Condition Hierarchy (Ancestors)

Wounds and InjuriesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

BenzopyransPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingTocopherols

Study Officials

  • Perenlei Enkhbaatar, MD, PhD

    University of Texas

    PRINCIPAL INVESTIGATOR

  • Linda E Sousse, PhD, MBA

    University of Texas

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 10, 2012

First Posted

December 13, 2012

Study Start

February 1, 2013

Primary Completion

August 1, 2017

Study Completion

September 1, 2017

Last Updated

January 18, 2019

Record last verified: 2019-01

Locations

US(3)