NCT01413620

Brief Summary

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.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Aug 2011

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
withdrawn

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

Study Start

First participant enrolled

August 1, 2011

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

August 9, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 10, 2011

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2021

Completed
Last Updated

September 21, 2021

Status Verified

September 1, 2021

Enrollment Period

6 years

First QC Date

August 9, 2011

Last Update Submit

September 20, 2021

Conditions

Burn Injury

Keywords

Vitamin EBurnOxidationLung DysfunctionFatty LiverLipid Peroxidation

Outcome Measures

Primary Outcomes (9)

  • Alpha-Tocopherol in Plasma, Adipose (also: Lung, Skin, Muscle, Liver in the case of Death)

    30 Days

  • Gamma-Tocopherol in Plasma, Adipose (also: Lung, Skin, Muscle, Liver in the case of Death)

    30 Days

  • Vitamin E Metabolites in Plasma, Urine

    30 Days

  • Malondialdehyde in Plasma, Urine (also: Lung, Skin, Muscle in the case of Death)

    30 Days

  • Isoprostanes in Plasma, Urine (also: Lung, Skin, Muscle in the case of Death)

    30 Days

  • Lipid Panel in Plasma and Triglyceride Concentration

    30 Days

  • Liver Ultrasound

    30 Days

  • Pulmonary Function Study Variables

    30 Days

  • Cardiopulmonary Stress Test

    30 Days

Secondary Outcomes (10)

  • Open Body Surface Area and Wound Healing

    30 Days

  • Weight

    30 Days

  • Basal Metabolic Rate

    30 Days

  • Diet History and Food Intake

    30 Days

  • Fluid Balance

    30 Days

  • +5 more secondary outcomes

Study Arms (2)

Vitamin E Treated

EXPERIMENTAL
Drug: dl-alpha-tocopheryl acetate

Untreated

NO INTERVENTION

Interventions

dl-alpha-tocopheryl acetateDRUG

Ages 6 months-1 year will receive 75 IU/day of dl-alpha-tocopheryl acetate, while ages 2-5 years will receive 150 IU/day. 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.

Also known as: Vitamin E, Aqueous Vitamin E Oral Drops, Silarx, No. 54838-0005-30
Vitamin E Treated

Eligibility Criteria

Age6 Months - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Age: 6 months - 85 years
  • \>20% TBSA burn

You may not qualify if:

  • Bleeding disorders
  • Positive hepatitis or HIV screens
  • Pregnancy (women)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shriners Hospitals for Children

Galveston, Texas, 77555, United States

Location

MeSH Terms

Conditions

BurnsFatty Liver

Interventions

alpha-TocopherolVitamin E

Condition Hierarchy (Ancestors)

Wounds and InjuriesLiver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

TocopherolsBenzopyransPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Jong O Lee, MD

    University of Texas Medical Branch, Shriners Hospitals for Children

    PRINCIPAL INVESTIGATOR

  • Hal K Hawkins, MD, 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

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Surgery and Faculty Surgeon

Study Record Dates

First Submitted

August 9, 2011

First Posted

August 10, 2011

Study Start

August 1, 2011

Primary Completion

August 1, 2017

Study Completion

August 1, 2021

Last Updated

September 21, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)