Trial Outcomes & Findings for The Effect of Selenium Supplementation Among Pediatric Patients With Burns (NCT NCT00860379)
NCT ID: NCT00860379
Last Updated: 2021-07-29
Results Overview
plasma selenium of all subjects was assessed
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
14 participants
Primary outcome timeframe
Average plasma selenium calculated over 8 weeks, assessed weekly.
Results posted on
2021-07-29
Participant Flow
Participant milestones
| Measure |
Placebo
Placebo
Placebo: IV saline as placebo
|
Selenium 2 ug/kg
Subject will receive 2 ug/kg of IV selenium per day
Selenium1: 2 ug/kg
|
Selenium 4 ug/kg
Subject will receive 4 ug/kg of IV selenium per day
Selenium2: 4 ug/kg
|
|---|---|---|---|
|
Overall Study
STARTED
|
4
|
6
|
4
|
|
Overall Study
COMPLETED
|
4
|
6
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Effect of Selenium Supplementation Among Pediatric Patients With Burns
Baseline characteristics by cohort
| Measure |
Placebo
n=4 Participants
Placebo
Placebo: IV saline as placebo
|
Selenium1
n=6 Participants
Subject will receive 2 ug/kg of IV selenium per day
Selenium1: 2 ug/kg
|
Selenium2
n=4 Participants
Subject will receive 4 ug/kg of IV selenium per day
Selenium2: 4 ug/kg
|
Total
n=14 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
3.8 years
STANDARD_DEVIATION 0.66 • n=99 Participants
|
4.3 years
STANDARD_DEVIATION 4.0 • n=107 Participants
|
6.3 years
STANDARD_DEVIATION 5.39 • n=206 Participants
|
4.74 years
STANDARD_DEVIATION 3.74 • n=7 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
7 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
7 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
12 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=99 Participants
|
6 participants
n=107 Participants
|
4 participants
n=206 Participants
|
14 participants
n=7 Participants
|
|
Total Body Surface Area (TBSA) burn injury
|
48.5 % of body surface area burn
STANDARD_DEVIATION 9.29 • n=99 Participants
|
42.8 % of body surface area burn
STANDARD_DEVIATION 23.16 • n=107 Participants
|
49.3 % of body surface area burn
STANDARD_DEVIATION 26.25 • n=206 Participants
|
46.25 % of body surface area burn
STANDARD_DEVIATION 19.88 • n=7 Participants
|
PRIMARY outcome
Timeframe: Average plasma selenium calculated over 8 weeks, assessed weekly.Population: pediatric burn patients
plasma selenium of all subjects was assessed
Outcome measures
| Measure |
Placebo
n=4 Participants
Placebo
Placebo: IV saline as placebo
|
Selenium1
n=6 Participants
Subject will receive 2 ug/kg of IV selenium per day
Selenium1: 2 ug/kg
|
Selenium2
n=4 Participants
Subject will receive 4 ug/kg of IV selenium per day
Selenium2: 4 ug/kg
|
|---|---|---|---|
|
Plasma Selenium
|
45 ng/mL
Standard Deviation 5.2
|
46 ng/mL
Standard Deviation 19.1
|
52.9 ng/mL
Standard Deviation 12.6
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Selenium1
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Selenium2
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place