Trial Outcomes & Findings for Ghrelin Levels in Children With Poor Growth (NCT NCT01070173)
NCT ID: NCT01070173
Last Updated: 2013-02-18
Results Overview
Recruitment status
COMPLETED
Target enrollment
52 participants
Primary outcome timeframe
Will be measured with baseline screening labs at enrollment.
Results posted on
2013-02-18
Participant Flow
Fifty-two patients were recruited into the study.
Participant milestones
| Measure |
Short Stature
Poor linear growth Group
|
Poor Weight Gain (Failure-To-Thrive)
Poor Weight Gain (Failure-To-Thrive) Group
|
Isolated Gastrointestinal Symptoms
Isolated Gastrointestinal Symptoms Group
|
|---|---|---|---|
|
Overall Study
STARTED
|
33
|
8
|
11
|
|
Overall Study
COMPLETED
|
33
|
8
|
11
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Ghrelin Levels in Children With Poor Growth
Baseline characteristics by cohort
| Measure |
Short Stature
n=33 Participants
Poor linear growth
|
Poor Weight Gain (Failure-To-Thrive)
n=8 Participants
Poor Weight Gain (Failure-To-Thrive)
|
Isolated Gastrointestinal Symptoms
n=11 Participants
Isolated Gastrointestinal Symptoms
|
Total
n=52 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
33 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
52 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Will be measured with baseline screening labs at enrollment.Population: All participants.
Outcome measures
| Measure |
Short Stature
n=33 Participants
Poor linear growth Group
|
Poor Weight Gain (Failure-To-Thrive)
n=8 Participants
Poor Weight Gain (Failure-To-Thrive) Group
|
Isolated Gastrointestinal Symptoms
n=11 Participants
Isolated Gastrointestinal Symptoms Group
|
|---|---|---|---|
|
Total Ghrelin Level
|
1063 pg/mL
Standard Deviation 77
|
1264 pg/mL
Standard Deviation 245
|
1157 pg/mL
Standard Deviation 105
|
PRIMARY outcome
Timeframe: Will be measured with baseline screening labs at enrollment.Population: All participants.
Outcome measures
| Measure |
Short Stature
n=33 Participants
Poor linear growth Group
|
Poor Weight Gain (Failure-To-Thrive)
n=8 Participants
Poor Weight Gain (Failure-To-Thrive) Group
|
Isolated Gastrointestinal Symptoms
n=11 Participants
Isolated Gastrointestinal Symptoms Group
|
|---|---|---|---|
|
Acylated Ghrelin Level
|
190 pg/mL
Standard Deviation 34
|
465 pg/mL
Standard Deviation 128
|
176 pg/mL
Standard Deviation 37
|
Adverse Events
Short Stature
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Poor Weight Gain (Failure-To-Thrive)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Isolated Gastrointestinal Symptoms
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