Trial Outcomes & Findings for Free Fatty Acids, Body Weight, and Growth Hormones Secretion in Children (NCT NCT01237041)
NCT ID: NCT01237041
Last Updated: 2018-12-17
Results Overview
Growth hormone Area Under the Curve in response to niacin versus placebo over 4 hours. For growth hormone, samples collected at 0, 30, 60, 90, 120, 150, 180, 210, and 240 minutes.
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
37 participants
Primary outcome timeframe
4 hours
Results posted on
2018-12-17
Participant Flow
Of 37 enrolled, two withdrew from the study before being studied. 16 were ineligible. 7 subjects completed the first niacin dose-establishing protocol. 5 completed the second phase pilot study. A total of 5 subjects were randomized in the main study. Two subjects were eligible, but were never studied due to unavailability of study medications.
Participant milestones
| Measure |
Niacin First
Subjects receive niacin on day 1 then cross over to receive placebo on day 2.
Niacin: 500 mg po four times on one of the inpatient day
Placebo po four times on the next inpatient day
|
Placebo First
Subjects receive placebo on day 1 then cross over to receive niacin on day 2
Placebo po four times on an inpatient day Niacin: 500 mg po four times on the next inpatient day
|
Dose-Establishing Study 1 Niacin 250mg
Subjects received Niacin 250 mg every 2 hours for 3 doses (at 6am, 8am, and 10am).
|
Dose-Establishing Study 1 Niacin 500mg
Subjects received Niacin 500 mg every 2 hours for 3 doses (at 6am, 8am, and 10am).
|
Dose-Establishing Study 2 Niacin 500mg
Subjects received Niacin 500 mg hourly for 4 doses (administered at 7:30am, 8:30am, 9:30am, and 10:30am).
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
2
|
3
|
2
|
5
|
5
|
|
Overall Study
COMPLETED
|
2
|
3
|
2
|
5
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Free Fatty Acids, Body Weight, and Growth Hormones Secretion in Children
Baseline characteristics by cohort
| Measure |
Niacin First
n=2 Participants
Subjects receive niacin on day 1 then cross over to receive placebo on day 2.
Niacin: 500 mg po four times on one of the inpatient days
Placebo
|
Placebo First
n=3 Participants
Subjects receive placebo on day 1 then cross over to receive niacin on day 2
Niacin: 500 mg po four times on one of the inpatient days
Placebo
|
Dose-Establishing Study 1 Niacin 250mg
n=2 Participants
Niacin 250mg x 3 doses 2 hours apart at 6AM, 8AM, and 10AM
|
Dose-Establishing Study 1 Niacin 500mg
n=5 Participants
Niacin 500mg x 3 doses 2 hours apart 6AM, 8AM, and 10AM
|
Dose-Establishing Study 2 Niacin 500mg
n=5 Participants
Niacin 500mg x 4 doses 1 hours apart 7:30AM, 8:30AM, 9:30AM, and 10:30AM
|
Total
n=17 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
11.4 years
STANDARD_DEVIATION 2.3 • n=5 Participants
|
10.8 years
STANDARD_DEVIATION 1.3 • n=7 Participants
|
10.5 years
STANDARD_DEVIATION 2.2 • n=5 Participants
|
9.7 years
STANDARD_DEVIATION 2.0 • n=4 Participants
|
9.3 years
STANDARD_DEVIATION 1.9 • n=21 Participants
|
10.1 years
STANDARD_DEVIATION 1.8 • n=10 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
5 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
12 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
16 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
7 Participants
n=10 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
9 Participants
n=10 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Region of Enrollment
United States
|
2 participants
n=5 Participants
|
3 participants
n=7 Participants
|
2 participants
n=5 Participants
|
5 participants
n=4 Participants
|
5 participants
n=21 Participants
|
17 participants
n=10 Participants
|
PRIMARY outcome
Timeframe: 4 hoursPopulation: No placebo was given during the dose-establishing arms, so no data are reported for placebo.
Growth hormone Area Under the Curve in response to niacin versus placebo over 4 hours. For growth hormone, samples collected at 0, 30, 60, 90, 120, 150, 180, 210, and 240 minutes.
Outcome measures
| Measure |
All Randomized Subjects
n=5 Participants
Results of both randomization orders to assess effect of niacin
|
Dose-Establishing Study 1 Niacin 250mg
n=2 Participants
Dose-Establishing Study 1 Niacin 250mg every 2 hours for 3 doses
|
Dose-Establishing Study 1 Niacin 500mg
n=5 Participants
Dose-Establishing Study 1 Niacin 500mg every 2 hours for 3 doses
|
Dose-Establishing Study 2 Niacin 500mg
n=5 Participants
Dose-Establishing Study 2 Niacin 500mg every 1 hour for 4 doses
|
|---|---|---|---|---|
|
Growth Hormone Secretion Area Under the Curve in Response to Niacin and Placebo Over Time
Niacin
|
589.6 min*ng/mL
Standard Deviation 437.6
|
32.0 min*ng/mL
Standard Deviation 20.7
|
84.0 min*ng/mL
Standard Deviation 68.6
|
394.6 min*ng/mL
Standard Deviation 217.9
|
|
Growth Hormone Secretion Area Under the Curve in Response to Niacin and Placebo Over Time
Placebo
|
638.5 min*ng/mL
Standard Deviation 513.9
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 4 hoursPopulation: Dose-establishing participants did not have placebo, so there are no data for those cells.
Effect of niacin vs placebo on Free Fatty Acids (FFA) Area Under the Curve in response to Niacin and Placebo over 4 hours. For FFA, samples collected at 0, 30, 60, 90, 120, 150, 180, 210, and 240 minutes
Outcome measures
| Measure |
All Randomized Subjects
n=5 Participants
Results of both randomization orders to assess effect of niacin
|
Dose-Establishing Study 1 Niacin 250mg
n=2 Participants
Dose-Establishing Study 1 Niacin 250mg every 2 hours for 3 doses
|
Dose-Establishing Study 1 Niacin 500mg
n=5 Participants
Dose-Establishing Study 1 Niacin 500mg every 2 hours for 3 doses
|
Dose-Establishing Study 2 Niacin 500mg
n=5 Participants
Dose-Establishing Study 2 Niacin 500mg every 1 hour for 4 doses
|
|---|---|---|---|---|
|
Free Fatty Acids (FFA) Area Under the Curve in Response to Niacin and Placebo Over 4 Hours
Niacin FFA AUC
|
37567 Min*UEq/L
Standard Deviation 12065
|
164056 Min*UEq/L
Standard Deviation 110047
|
94346 Min*UEq/L
Standard Deviation 42439
|
48870 Min*UEq/L
Standard Deviation 20243
|
|
Free Fatty Acids (FFA) Area Under the Curve in Response to Niacin and Placebo Over 4 Hours
Placebo FFA AUC
|
106047 Min*UEq/L
Standard Deviation 37010
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 4 hoursPopulation: Dose-establishing participants did not have placebo, so there are no data for those cells.
Growth hormone-releasing hormone (GHRH) Area Under the Curve in response to Niacin and Placebo over 4 hours. For GHRH, samples collected at 0, 60, 120, 180, and 240 minutes.
Outcome measures
| Measure |
All Randomized Subjects
n=5 Participants
Results of both randomization orders to assess effect of niacin
|
Dose-Establishing Study 1 Niacin 250mg
n=2 Participants
Dose-Establishing Study 1 Niacin 250mg every 2 hours for 3 doses
|
Dose-Establishing Study 1 Niacin 500mg
n=5 Participants
Dose-Establishing Study 1 Niacin 500mg every 2 hours for 3 doses
|
Dose-Establishing Study 2 Niacin 500mg
n=5 Participants
Dose-Establishing Study 2 Niacin 500mg every 1 hour for 4 doses
|
|---|---|---|---|---|
|
Growth Hormone-releasing Hormone (GHRH) Area Under the Curve in Response to Niacin and Placebo Over 4 Hours
Niacin GHRH
|
2535 min*pg/mL
Standard Deviation 898.2
|
2415 min*pg/mL
Standard Deviation 129.9
|
2548 min*pg/mL
Standard Deviation 637.5
|
5382 min*pg/mL
Standard Deviation 8090.1
|
|
Growth Hormone-releasing Hormone (GHRH) Area Under the Curve in Response to Niacin and Placebo Over 4 Hours
Placbo GHRH
|
2283 min*pg/mL
Standard Deviation 1505.6
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 4 hoursPopulation: Dose-establishing participants did not have placebo, so there are no data for those cells. Dose-establishing study 1 niacin 250mg participants did not have somatostatin measured, so those cells are also not completed
Effect of niacin vs placebo on Somatostatin (SST) Area Under the Curve in response to Niacin and Placebo over 4 hours. For somatostatin, samples collected at 0, 60, 120, 180, and 240 minutes.
Outcome measures
| Measure |
All Randomized Subjects
n=5 Participants
Results of both randomization orders to assess effect of niacin
|
Dose-Establishing Study 1 Niacin 250mg
Dose-Establishing Study 1 Niacin 250mg every 2 hours for 3 doses
|
Dose-Establishing Study 1 Niacin 500mg
n=5 Participants
Dose-Establishing Study 1 Niacin 500mg every 2 hours for 3 doses
|
Dose-Establishing Study 2 Niacin 500mg
n=5 Participants
Dose-Establishing Study 2 Niacin 500mg every 1 hour for 4 doses
|
|---|---|---|---|---|
|
Somatostatin (SST) Area Under the Curve in Response to Niacin and Placebo Over 4 Hours
Niacin Somatostatin
|
1329 min*pg/mL
Standard Deviation 615.7
|
—
|
849.8 min*pg/mL
Standard Deviation 484.5
|
1578 min*pg/mL
Standard Deviation 692.1
|
|
Somatostatin (SST) Area Under the Curve in Response to Niacin and Placebo Over 4 Hours
Placebo Somatostatin
|
1248 min*pg/mL
Standard Deviation 461.5
|
—
|
—
|
—
|
Adverse Events
All Randomized Subjects
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Dose-Finding Study 1 Niacin 250mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Dose-Finding Study 1 Niacin 500mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Dose-Finding Study 2 Niacin 500mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
All Randomized Subjects
n=5 participants at risk
Results of both randomization orders to assess effect of Niacin 500mg every 1 hour for 4 doses
|
Dose-Finding Study 1 Niacin 250mg
n=2 participants at risk
Results from Niacin 250mg every 2 hours for 3 doses
|
Dose-Finding Study 1 Niacin 500mg
n=5 participants at risk
Results from Niacin 500mg every 2 hours for 3 doses
|
Dose-Finding Study 2 Niacin 500mg
n=5 participants at risk
Results from Niacin 500mg every 1 hour for 4 doses
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
60.0%
3/5 • Number of events 8 • 4 hours
Adverse events by hourly questionnaire
|
0.00%
0/2 • 4 hours
Adverse events by hourly questionnaire
|
20.0%
1/5 • Number of events 3 • 4 hours
Adverse events by hourly questionnaire
|
60.0%
3/5 • Number of events 9 • 4 hours
Adverse events by hourly questionnaire
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place