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Free Fatty Acids, Body Weight, and Growth Hormones Secretion in Children

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ClinicalTrials.gov Identifier: NCT01237041
Recruitment Status : Terminated (Study Medication unavailable)
First Posted : November 9, 2010
Results First Posted : December 17, 2018
Last Update Posted : December 17, 2018
Sponsor:
Information provided by (Responsible Party):
Jack Yanovski, M.D., Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Diagnostic
Conditions Obesity
Short Stature
Growth Hormone Deficiency
Interventions Drug: Niacin First
Drug: Placebo First
Drug: Dose-Establishing Study 1 Niacin 250mg
Drug: Dose-Establishing Study 1 Niacin 500mg
Drug: Dose-Establishing Study 2 Niacin 500mg
Enrollment 37
Recruitment Details  
Pre-assignment Details 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.
Arm/Group Title Niacin First Placebo First Dose-Establishing Study 1 Niacin 250mg Dose-Establishing Study 1 Niacin 500mg Dose-Establishing Study 2 Niacin 500mg
Hide Arm/Group Description

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

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

Subjects received Niacin 250 mg every 2 hours for 3 doses (at 6am, 8am, and 10am). Subjects received Niacin 500 mg every 2 hours for 3 doses (at 6am, 8am, and 10am). Subjects received Niacin 500 mg hourly for 4 doses (administered at 7:30am, 8:30am, 9:30am, and 10:30am).
Period Title: Overall Study
Started 2 3 2 5 5
Completed 2 3 2 5 5
Not Completed 0 0 0 0 0
Arm/Group Title Niacin First Placebo First Dose-Establishing Study 1 Niacin 250mg Dose-Establishing Study 1 Niacin 500mg Dose-Establishing Study 2 Niacin 500mg Total
Hide Arm/Group Description

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

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

Niacin 250mg x 3 doses 2 hours apart at 6AM, 8AM, and 10AM Niacin 500mg x 3 doses 2 hours apart 6AM, 8AM, and 10AM Niacin 500mg x 4 doses 1 hours apart 7:30AM, 8:30AM, 9:30AM, and 10:30AM Total of all reporting groups
Overall Number of Baseline Participants 2 3 2 5 5 17
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 2 participants 3 participants 2 participants 5 participants 5 participants 17 participants
11.4  (2.3) 10.8  (1.3) 10.5  (2.2) 9.7  (2.0) 9.3  (1.9) 10.1  (1.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 3 participants 2 participants 5 participants 5 participants 17 participants
Female
0
   0.0%
1
  33.3%
0
   0.0%
3
  60.0%
1
  20.0%
5
  29.4%
Male
2
 100.0%
2
  66.7%
2
 100.0%
2
  40.0%
4
  80.0%
12
  70.6%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 3 participants 2 participants 5 participants 5 participants 17 participants
Hispanic or Latino
1
  50.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   5.9%
Not Hispanic or Latino
1
  50.0%
3
 100.0%
2
 100.0%
5
 100.0%
5
 100.0%
16
  94.1%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 3 participants 2 participants 5 participants 5 participants 17 participants
American Indian or Alaska Native
0
   0.0%
1
  33.3%
0
   0.0%
0
   0.0%
0
   0.0%
1
   5.9%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
2
 100.0%
3
  60.0%
2
  40.0%
7
  41.2%
White
2
 100.0%
2
  66.7%
0
   0.0%
2
  40.0%
3
  60.0%
9
  52.9%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 2 participants 3 participants 2 participants 5 participants 5 participants 17 participants
2 3 2 5 5 17
1.Primary Outcome
Title Growth Hormone Secretion Area Under the Curve in Response to Niacin and Placebo Over Time
Hide Description 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.
Time Frame 4 hours
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
No placebo was given during the dose-establishing arms, so no data are reported for placebo.
Arm/Group Title All Randomized Subjects Dose-Establishing Study 1 Niacin 250mg Dose-Establishing Study 1 Niacin 500mg Dose-Establishing Study 2 Niacin 500mg
Hide Arm/Group Description:
Results of both randomization orders to assess effect of niacin
Dose-Establishing Study 1 Niacin 250mg every 2 hours for 3 doses
Dose-Establishing Study 1 Niacin 500mg every 2 hours for 3 doses
Dose-Establishing Study 2 Niacin 500mg every 1 hour for 4 doses
Overall Number of Participants Analyzed 5 2 5 5
Mean (Standard Deviation)
Unit of Measure: min*ng/mL
Niacin Number Analyzed 5 participants 2 participants 5 participants 5 participants
589.6  (437.6) 32.0  (20.7) 84.0  (68.6) 394.6  (217.9)
Placebo Number Analyzed 5 participants 0 participants 0 participants 0 participants
638.5  (513.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dose-Establishing Study 1 Niacin 250mg, Dose-Establishing Study 1 Niacin 500mg, Dose-Establishing Study 2 Niacin 500mg
Comments ANOVA to compare AUC of GH among groups
Type of Statistical Test Superiority
Comments Univariate ANOVA
Statistical Test of Hypothesis P-Value .016
Comments A priori threshold p<0.05
Method ANOVA
Comments Comparison of 3 dose-finding groups. Post-hoc comparisons between groups also done.
2.Secondary Outcome
Title Free Fatty Acids (FFA) Area Under the Curve in Response to Niacin and Placebo Over 4 Hours
Hide Description 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
Time Frame 4 hours
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Dose-establishing participants did not have placebo, so there are no data for those cells.
Arm/Group Title All Randomized Subjects Dose-Establishing Study 1 Niacin 250mg Dose-Establishing Study 1 Niacin 500mg Dose-Establishing Study 2 Niacin 500mg
Hide Arm/Group Description:
Results of both randomization orders to assess effect of niacin
Dose-Establishing Study 1 Niacin 250mg every 2 hours for 3 doses
Dose-Establishing Study 1 Niacin 500mg every 2 hours for 3 doses
Dose-Establishing Study 2 Niacin 500mg every 1 hour for 4 doses
Overall Number of Participants Analyzed 5 2 5 5
Mean (Standard Deviation)
Unit of Measure: Min*UEq/L
Niacin FFA AUC Number Analyzed 5 participants 2 participants 5 participants 5 participants
37567  (12065) 164056  (110047) 94346  (42439) 48870  (20243)
Placebo FFA AUC Number Analyzed 5 participants 0 participants 0 participants 0 participants
106047  (37010)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dose-Establishing Study 1 Niacin 250mg, Dose-Establishing Study 1 Niacin 500mg, Dose-Establishing Study 2 Niacin 500mg
Comments Analysis of FFA Area Under Curve in dose-finding studies. Data were log-transformed before analysis.
Type of Statistical Test Superiority
Comments ANOVA of the 3 dose-finding groups. Data transformed using log(10) for analysis
Statistical Test of Hypothesis P-Value .043
Comments A priori threshold for significance p<0.05
Method ANOVA
Comments [Not Specified]
3.Secondary Outcome
Title Growth Hormone-releasing Hormone (GHRH) Area Under the Curve in Response to Niacin and Placebo Over 4 Hours
Hide Description 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.
Time Frame 4 hours
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Dose-establishing participants did not have placebo, so there are no data for those cells.
Arm/Group Title All Randomized Subjects Dose-Establishing Study 1 Niacin 250mg Dose-Establishing Study 1 Niacin 500mg Dose-Establishing Study 2 Niacin 500mg
Hide Arm/Group Description:
Results of both randomization orders to assess effect of niacin
Dose-Establishing Study 1 Niacin 250mg every 2 hours for 3 doses
Dose-Establishing Study 1 Niacin 500mg every 2 hours for 3 doses
Dose-Establishing Study 2 Niacin 500mg every 1 hour for 4 doses
Overall Number of Participants Analyzed 5 2 5 5
Mean (Standard Deviation)
Unit of Measure: min*pg/mL
Niacin GHRH Number Analyzed 5 participants 2 participants 5 participants 5 participants
2535  (898.2) 2415  (129.9) 2548  (637.5) 5382  (8090.1)
Placbo GHRH Number Analyzed 5 participants 0 participants 0 participants 0 participants
2283  (1505.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dose-Establishing Study 1 Niacin 250mg, Dose-Establishing Study 1 Niacin 500mg, Dose-Establishing Study 2 Niacin 500mg
Comments ANOVA, 3 dose-finding groups
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.543
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
4.Secondary Outcome
Title Somatostatin (SST) Area Under the Curve in Response to Niacin and Placebo Over 4 Hours
Hide Description 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.
Time Frame 4 hours
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title All Randomized Subjects Dose-Establishing Study 1 Niacin 250mg Dose-Establishing Study 1 Niacin 500mg Dose-Establishing Study 2 Niacin 500mg
Hide Arm/Group Description:
Results of both randomization orders to assess effect of niacin
Dose-Establishing Study 1 Niacin 250mg every 2 hours for 3 doses
Dose-Establishing Study 1 Niacin 500mg every 2 hours for 3 doses
Dose-Establishing Study 2 Niacin 500mg every 1 hour for 4 doses
Overall Number of Participants Analyzed 5 0 5 5
Mean (Standard Deviation)
Unit of Measure: min*pg/mL
Niacin Somatostatin Number Analyzed 5 participants 0 participants 5 participants 5 participants
1329  (615.7) 849.8  (484.5) 1578  (692.1)
Placebo Somatostatin Number Analyzed 5 participants 0 participants 0 participants 0 participants
1248  (461.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dose-Establishing Study 1 Niacin 500mg, Dose-Establishing Study 2 Niacin 500mg
Comments ANOVA, 2 groups, essentially an unpaired t-test.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .113
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Time Frame 4 hours
Adverse Event Reporting Description Adverse events by hourly questionnaire
 
Arm/Group Title All Randomized Subjects Dose-Finding Study 1 Niacin 250mg Dose-Finding Study 1 Niacin 500mg Dose-Finding Study 2 Niacin 500mg
Hide Arm/Group Description Results of both randomization orders to assess effect of Niacin 500mg every 1 hour for 4 doses Results from Niacin 250mg every 2 hours for 3 doses Results from Niacin 500mg every 2 hours for 3 doses Results from Niacin 500mg every 1 hour for 4 doses
All-Cause Mortality
All Randomized Subjects Dose-Finding Study 1 Niacin 250mg Dose-Finding Study 1 Niacin 500mg Dose-Finding Study 2 Niacin 500mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/5 (0.00%)      0/2 (0.00%)      0/5 (0.00%)      0/5 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
All Randomized Subjects Dose-Finding Study 1 Niacin 250mg Dose-Finding Study 1 Niacin 500mg Dose-Finding Study 2 Niacin 500mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/5 (0.00%)      0/2 (0.00%)      0/5 (0.00%)      0/5 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
All Randomized Subjects Dose-Finding Study 1 Niacin 250mg Dose-Finding Study 1 Niacin 500mg Dose-Finding Study 2 Niacin 500mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/5 (60.00%)      0/2 (0.00%)      1/5 (20.00%)      3/5 (60.00%)    
Gastrointestinal disorders         
Nausea  1 [1]  3/5 (60.00%)  8 0/2 (0.00%)  0 1/5 (20.00%)  3 3/5 (60.00%)  9
1
Term from vocabulary, CTCAE (4.0)
Indicates events were collected by systematic assessment
[1]
Nausea during niacin
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. Jack Yanovski
Organization: NICHD, National Institutes of Health
Phone: 13014960858
Responsible Party: Jack Yanovski, M.D., Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier: NCT01237041     History of Changes
Other Study ID Numbers: 110004
11-CH-0004 ( Other Identifier: NIH Clinical Center Protocol Number )
First Submitted: November 6, 2010
First Posted: November 9, 2010
Results First Submitted: November 14, 2018
Results First Posted: December 17, 2018
Last Update Posted: December 17, 2018