Trial Outcomes & Findings for Vitamin E Supplementation in Burned Patients (NCT NCT01749371)
NCT ID: NCT01749371
Last Updated: 2026-07-20
Results Overview
Number of participants who had plasma alpha- and gamma-tocopherol levels measured during the study.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
27 participants
Primary outcome timeframe
Days 0-30
Results posted on
2026-07-20
Participant Flow
Participant milestones
| Measure |
Early Vitamin E
Vitamin E is administered from Days 1-15 after the initial excision surgery after admission.
Vitamin E: 1200 IU dl-alpha tocopheryl acetate after the initial excision surgery after admission (days 1-15 or days 16-30)
|
Delayed Vitamin E
Vitamin E is administered from Days 16-30 after the initial excision surgery after admission.
Vitamin E: 1200 IU dl-alpha tocopheryl acetate after the initial excision surgery after admission (days 1-15 or days 16-30)
|
|---|---|---|
|
Overall Study
STARTED
|
11
|
16
|
|
Overall Study
COMPLETED
|
11
|
16
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Early Vitamin E
n=11 Participants
Vitamin E is administered from Days 1-15 after the initial excision surgery after admission.
Vitamin E: 1200 IU dl-alpha tocopheryl acetate after the initial excision surgery after admission (days 1-15 or days 16-30)
|
Delayed Vitamin E
n=16 Participants
Vitamin E is administered from Days 16-30 after the initial excision surgery after admission.
Vitamin E: 1200 IU dl-alpha tocopheryl acetate after the initial excision surgery after admission (days 1-15 or days 16-30)
|
Total
n=27 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
44 years
STANDARD_DEVIATION 15 • n=11 Participants
|
38 years
STANDARD_DEVIATION 13 • n=16 Participants
|
41 years
STANDARD_DEVIATION 14 • n=27 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=11 Participants
|
3 Participants
n=16 Participants
|
5 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=11 Participants
|
13 Participants
n=16 Participants
|
22 Participants
n=27 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Percentage of Participants with Third Degree Total Body Surface Area (TBSA)Burn
|
40 % of participants
n=11 Participants
|
44 % of participants
n=16 Participants
|
42 % of participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Days 0-30Number of participants who had plasma alpha- and gamma-tocopherol levels measured during the study.
Outcome measures
| Measure |
Early Vitamin E
n=11 Participants
Vitamin E is administered from Days 1-15 after the initial excision surgery after admission.
Vitamin E: 1200 IU dl-alpha tocopheryl acetate after the initial excision surgery after admission (days 1-15 or days 16-30)
|
Delayed Vitamin E
n=16 Participants
Vitamin E is administered from Days 16-30 after the initial excision surgery after admission.
Vitamin E: 1200 IU dl-alpha tocopheryl acetate after the initial excision surgery after admission (days 1-15 or days 16-30)
|
|---|---|---|
|
Number of Participants Assessed for Plasma Alpha- and Gamma-Tocopherol Levels
|
11 Participants
|
16 Participants
|
SECONDARY outcome
Timeframe: Day 30Number of participants who completed pulmonary function testing during the study period.
Outcome measures
| Measure |
Early Vitamin E
n=11 Participants
Vitamin E is administered from Days 1-15 after the initial excision surgery after admission.
Vitamin E: 1200 IU dl-alpha tocopheryl acetate after the initial excision surgery after admission (days 1-15 or days 16-30)
|
Delayed Vitamin E
n=16 Participants
Vitamin E is administered from Days 16-30 after the initial excision surgery after admission.
Vitamin E: 1200 IU dl-alpha tocopheryl acetate after the initial excision surgery after admission (days 1-15 or days 16-30)
|
|---|---|---|
|
Number of Participants Completing Pulmonary Function Testing
|
11 Participants
|
16 Participants
|
SECONDARY outcome
Timeframe: Days 0-30Number of participants with plasma and urine malondialdehyde, isoprostanes, and Vitamin E metabolites measured during the study.
Outcome measures
| Measure |
Early Vitamin E
n=11 Participants
Vitamin E is administered from Days 1-15 after the initial excision surgery after admission.
Vitamin E: 1200 IU dl-alpha tocopheryl acetate after the initial excision surgery after admission (days 1-15 or days 16-30)
|
Delayed Vitamin E
n=16 Participants
Vitamin E is administered from Days 16-30 after the initial excision surgery after admission.
Vitamin E: 1200 IU dl-alpha tocopheryl acetate after the initial excision surgery after admission (days 1-15 or days 16-30)
|
|---|---|---|
|
Number of Participants Assessed for Plasma and Urine Oxidative Stress and Vitamin E Metabolite Biomarkers
|
11 Participants
|
16 Participants
|
SECONDARY outcome
Timeframe: Days 0-30Number of participants with adipose tissue alpha- and gamma-tocopherol concentrations evaluated during the study.
Outcome measures
| Measure |
Early Vitamin E
n=11 Participants
Vitamin E is administered from Days 1-15 after the initial excision surgery after admission.
Vitamin E: 1200 IU dl-alpha tocopheryl acetate after the initial excision surgery after admission (days 1-15 or days 16-30)
|
Delayed Vitamin E
n=16 Participants
Vitamin E is administered from Days 16-30 after the initial excision surgery after admission.
Vitamin E: 1200 IU dl-alpha tocopheryl acetate after the initial excision surgery after admission (days 1-15 or days 16-30)
|
|---|---|---|
|
Number of Participants Assessed for Adipose Alpha- and Gamma-Tocopherol Concentrations
|
11 Participants
|
16 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Days 0-30Population: This outcome measure was not assessed during the study; therefore, no participants were analyzed for this outcome.
Assessment of variables of the wound such as redness and scar height
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 30Population: This outcome measure was not assessed during the study; therefore, no participants were analyzed for this outcome.
Assessment of strength and cardiopulmonary function through use of exercise
Outcome measures
Outcome data not reported
Adverse Events
Early Vitamin E
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Delayed Vitamin E
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Perenlei Enkhbaatar
University of Texas Medical Branch Galveston
Phone: 409-747-0096
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place