Clincosm LogoSign in Get a demo

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

Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) (NIH)
Overall Status
Terminated
CT.gov ID
NCT01237041
Collaborator
(none)
37
Enrollment
1
Location
5
Arms
77.4
Actual Duration (Months)
0.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Background:
  • Overweight and obese children and adults often have lower levels of growth hormone in the blood. Regulation of growth hormone may be tied to weight and free fatty acids in the blood. Current tests of growth hormone (such as those used when evaluating the heights of children who are markedly shorter than other children of comparable age) may be affected by other factors, including obesity. Researchers are interested in evaluating the levels of growth hormone and free fatty acids in the blood of children between 7 and 14 years of age who weigh more than children of a comparable age, or who are shorter than other children of a comparable age and have been recommended for growth hormone testing as part of an evaluation for their height.
Objectives:
  • To determine the effect of changes in free fatty acids in the blood on changes in growth hormone secretion in overweight or shorter children and young adolescents.
Eligibility:
  • Children and adolescents between 7 and 14 years of age who weigh more than or are shorter than other children of a comparable age and do not have any medical illnesses.
Design:

  • Participants will have two study visits, one of which will be a half day screening visit in the outpatient clinic and one of which will require 2 nights as an inpatient at the National Institutes of Health Clinical Center.

  • Participants should not eat or drink anything except water after 10 PM the night before or on the morning of the screening visit.

  • At the screening visit, participants will have a physical examination and medical history, provide blood and urine samples, have an oral glucose tolerance test (to check blood sugar levels), and have an x-ray of the left hand to check bone age.

  • The inpatient study visit will involve a physical examination and medical history, a full x-ray scan to study body fat and muscle, frequent blood tests throughout the visit, and various medications to stimulate growth hormone production and lower levels of free fatty acids in the blood.

Condition or Disease Intervention/Treatment Phase
  • 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
 Phase 1/Phase 2

Detailed Description

Obese children and adults display lower spontaneous and stimulated growth hormone (GH) secretion. It is presumed that dysregulation of some of the factors normally involved in controlling GH secretion underlies the hyposomatotropinemia of obesity, given that GH production usually normalizes after weight loss. Free fatty acids (FFA) are one factor thought to be involved in regulation of GH secretion. Niacin is a nicotinic acid derivative that inhibits lipolysis and lowers circulating FFA concentrations. Nicotinic acid derivatives have been used in several adult studies examining GH secretion. Specifically in obese adults, inhibition of lipolysis has been found to increase spontaneous and stimulated GH production, presumably due to direct effects of FFA on hypothalamic GH-regulating neurons. Thus far no pediatric studies have examined the effects of niacin on GH secretion, and there is only one small pediatric study of normal weight prepubertal children growing at the 5th-10th percentile in height has tested the effects of lipolytic inhibition by acipimox (a related medication also derived from nicotinic acid) on GH secretion. There are no data in obese children demonstrating the effects of inhibition of lipolysis on GH secretion.

We propose to investigate one of the mechanisms through which high adiposity alters GH secretion in children by testing the effects of inhibiting lipolysis. First we will conduct dose establishing studies to determine the appropriate dose of niacin needed to suppress FFA concentrations in children. We will then conduct the main study, designed as a pilot randomized, double-blind placebo controlled trial of niacin administration, to assess its effects on stimulated GH secretion. We hypothesize that in overweight children niacin will lead to a fall in free fatty acid concentrations and consequently a rise in stimulated GH secretion. We further hypothesize that the overweight subjects will demonstrate stimulated GH secretion profiles with niacin similar to those of control subjects who receive placebo. We expect this pilot study may help improve how diagnostic testing is carried out for growth hormone deficiency in children.

Study Design

Study Type:
Interventional
Actual Enrollment :
37 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
First, we conducted dose-establishing studies using 250mg every 2 hours x 3 doses (2 subjects), 500mg every two hours x 3 doses (5 subjects), and 500mg hourly x 4 doses (5 subjects). This dose-establishing study was followed by the randomized crossover trial using 500mg hourly x 4 doses in conjunction with growth hormone stimulation testing. The RCT was terminated early because of inability to obtain necessary study medications.First, we conducted dose-establishing studies using 250mg every 2 hours x 3 doses (2 subjects), 500mg every two hours x 3 doses (5 subjects), and 500mg hourly x 4 doses (5 subjects). This dose-establishing study was followed by the randomized crossover trial using 500mg hourly x 4 doses in conjunction with growth hormone stimulation testing. The RCT was terminated early because of inability to obtain necessary study medications.
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
Masking only during the two arms of the randomized trial portion of the study, not during the dose-finding arms.
Primary Purpose:
Diagnostic
Official Title:
Free Fatty Acids, Body Weight, and Growth Hormone Secretion in Children
Actual Study Start Date :
Jul 1, 2011
Actual Primary Completion Date :
Oct 17, 2017
Actual Study Completion Date :
Dec 13, 2017

Arms and Interventions

Arm Intervention/Treatment
Experimental: Niacin First

Subjects receive niacin 500mg hourly for 4 hours on day 1 (at 7:30am, 8:30am, 9:30am, and 10:30am) then cross over to receive placebo hourly for 4 hours on day 2 at (7:30am, 8:30am, 9:30am, and 10:30am).

Drug: Niacin First
Niacin 500 mg po four times on one of the inpatient days, then placebo on another inpatient day
Other Names:
  • RCT Niacin First

    • Drug: Placebo First
    Placebo po four times on one of the inpatient days, then Niacin 500 mg po four times on another inpatient day
    Other Names:
  • RCT Placebo First

    		•
    Experimental: Placebo First

    Subjects receive placebo hourly for 4 hours on day 1 (at 7:30am, 8:30am, 9:30am, and 10:30am) then cross over to receive niacin hourly for 4 hours on day 2 (at 7:30am, 8:30am, 9:30am, and 10:30am).

    Drug: Niacin First
    Niacin 500 mg po four times on one of the inpatient days, then placebo on another inpatient day
    Other Names:
  • RCT Niacin First

    • Drug: Placebo First
    Placebo po four times on one of the inpatient days, then Niacin 500 mg po four times on another inpatient day
    Other Names:
  • RCT Placebo First

    		•
    Experimental: Dose-Establishing Study 1 Niacin 250mg

    Subjects received Niacin 250 mg every 2 hours for 3 doses (at 6am, 8am, and 10am).

    Drug: Dose-Establishing Study 1 Niacin 250mg
    Niacin 250 mg po three times at 2 hour intervals on an inpatient day
    Other Names:
  • Open-Label Niacin 250mg x 3 doses

    		•
    Experimental: Dose-Establishing Study 1 Niacin 500mg

    Subjects received Niacin 500 mg every 2 hours for 3 doses (at 6am, 8am, and 10am).

    Drug: Dose-Establishing Study 1 Niacin 500mg
    Niacin 500 mg po three times at 2 hour intervals on an inpatient day
    Other Names:
  • Open-Label Niacin 500mg x 3 doses

    		•
    Experimental: 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).

    Drug: Dose-Establishing Study 2 Niacin 500mg
    Open-Label Niacin 500mg four times at 1 hour intervals on an inpatient day
    Other Names:
  • Open-Label Niacin 500mg x four doses

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Growth Hormone Secretion Area Under the Curve in Response to Niacin and Placebo Over Time [4 hours]

      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.

    Secondary Outcome Measures

    1. Free Fatty Acids (FFA) Area Under the Curve in Response to Niacin and Placebo Over 4 Hours [4 hours]

      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

    2. Growth Hormone-releasing Hormone (GHRH) Area Under the Curve in Response to Niacin and Placebo Over 4 Hours [4 hours]

      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.

    3. Somatostatin (SST) Area Under the Curve in Response to Niacin and Placebo Over 4 Hours [4 hours]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    7 Years to 14 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    • INCLUSION CRITERIA:

    Subjects will qualify for the overweight group for the dose-establishing studies 1 and 2 and main study) if they meet the following criteria:

    1. Good general health.

    2. Age greater than or equal to 7 and less than 15 years.

    3. Tanner stage I, II or III for the breast among girls and testes less than10 mL for boys based upon an examination by a trained physician or nurse practitioner.

    4. Weight > 30 kg.

    5. Fasting plasma glucose < 100 mg/dL, 2 hour post-dextrose glucose < 140 mg/dL, and HgbA1C less than or equal to 6.4%.

    6. Females who are age 10 or greater must have a negative pregnancy test.

    7. Body mass index greater than or eqaul to 95th percentile determined by Centers for Disease Control age and sex specific data (given that most pathology of obesity does not usually emerge until children cross the 95th percentile).

    8. No evidence of growth failure as defined as height > 5th percentile.

    Subjects will qualify for the non-overweight control group (for the main study only) if they meet the following criteria:

    1. Recommended by a pediatric endocrinologist to undergo GH stimulation testing to establish the diagnosis of GH-deficiency.

    2. Good general health.

    3. Age greater than or equal to 7 and less than15 years.

    4. Tanner stage I, II or III for the breast among girls and testes less than 10 mL for boys based upon an examination by a trained physician or nurse practitioner.

    5. Weight > 30 kg.

    6. Fasting plasma glucose < 100 mg/dL, 2 hour post-dextrose glucose < 140 mg/dL, and HgbA1C less than or equal to 6.4%.

    7. Females who are age 10 or greater must have a negative pregnancy test.

    8. Height < 5th percentile.

    9. BMI between the 5th and 85th percentiles determined by Centers for Disease Control age and sex specific data.

    10. Birth weight and length not consistent with small for gestational age (SGA) criteria or a history of intrauterine growth restriction (IUGR) based on recall history.

    EXCLUSION CRITERIA (for the dose-establishing sutides 1 and 2, and the main study):
    Subjects will be excluded if they have any of the following:

    1. Baseline creatinine greater than or equal to 1.0 mg/dl.

    2. Significant cardiac or pulmonary disease likely to or resulting in hypoxia or decreased perfusion.

    3. Hepatic disease with elevated liver function tests (ALT or AST)greater than or equal to 1.5 the upper limits of normal.

    4. Pregnancy.

    5. Evidence for impaired glucose tolerance or Type 2 diabetes, including fasting plasma glucose greater than or equal to 100 mg/dL, 2 hour post-dextrose glucose greater than or equal to 140 mg/dL, or HgbA1C > 6.4%.

    6. Presence of other endocrinologic disorders leading to obesity (e.g. Cushing Syndrome).

    7. Any disorder that is known to affect GH secretion (e.g. untreated hypothyroidism) or use of any medication known to affect GH levels (including glucocorticoids and GH itself).

    8. Any other disorder that is known to affect stature including skeletal dysplasias.

    9. Recent use (within two years) of anorexiant medications, stimulant medications, or other medications felt to impact growth.

    10. Individuals who have, or whose parent or guardians have, current substance abuse or a psychiatric disorder or other condition that, in the opinion of the investigators, would impede competence or compliance or possibly hinder completion of the study.

    11. Individuals receiving medical treatment other than diet for hypertension or dyslipidemia.

    12. Individuals with evidence of precocious puberty as defined as palpable breast tissue noted in females before the age of 7, testicular size greater than or equal to 4cc in males before the age of 9, or bone age advancement more than 2 SD for chronologic age.

    13. Individuals receiving androgen or estrogen hormone therapy.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 National Institutes of Health Clinical Center, 9000 Rockville Pike Bethesda Maryland United States 20892

    Sponsors and Collaborators

    • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    Investigators

    • Principal Investigator: Jack A Yanovski, M.D., Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    Study Documents (Full-Text)

    More Information

    Publications

    Responsible Party:
    Jack Yanovski, M.D., Chief, Section on Growth and Obesity, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
    ClinicalTrials.gov Identifier:
    NCT01237041
    Other Study ID Numbers:
    • 110004
    • 11-CH-0004
    First Posted:
    Nov 9, 2010
    Last Update Posted:
    Dec 17, 2018
    Last Verified:
    Dec 1, 2018
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Jack Yanovski, M.D., Chief, Section on Growth and Obesity, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
    Child
    Body Fat
    Niacin
    Growth Hormone
    Obesity
    Overweight
    Growth Hormones
    Short Stature
    Children
    Additional relevant MeSH terms:
    Dwarfism
    Body Weight
    Niacin
    Niacinamide
    Nicotinic Acids

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail 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
    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

    Baseline Characteristics

    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
    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 Participants 2 3 2 5 5 17
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    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 (Count of Participants)
    Female
    0
    0%
    1
    33.3%
    0
    0%
    3
    60%
    1
    20%
    5
    29.4%
    Male
    2
    100%
    2
    66.7%
    2
    100%
    2
    40%
    4
    80%
    12
    70.6%
    Ethnicity (NIH/OMB) (Count of Participants)
    Hispanic or Latino
    1
    50%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    1
    5.9%
    Not Hispanic or Latino
    1
    50%
    3
    100%
    2
    100%
    5
    100%
    5
    100%
    16
    94.1%
    Unknown or Not Reported
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    0
    0%
    1
    33.3%
    0
    0%
    0
    0%
    0
    0%
    1
    5.9%
    Asian
    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%
    Black or African American
    0
    0%
    0
    0%
    2
    100%
    3
    60%
    2
    40%
    7
    41.2%
    White
    2
    100%
    2
    66.7%
    0
    0%
    2
    40%
    3
    60%
    9
    52.9%
    More than one race
    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%
    Region of Enrollment (participants) [Number]
    United States
    2
    100%
    3
    100%
    2
    100%
    5
    100%
    5
    100%
    17
    100%

    Outcome Measures

    1. Primary Outcome
    Title Growth Hormone Secretion Area Under the Curve in Response to Niacin and Placebo Over Time
    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

    Outcome Measure Data

    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
    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
    Measure Participants 5 2 5 5
    Niacin
    589.6
    (437.6)
    32.0
    (20.7)
    84.0
    (68.6)
    394.6
    (217.9)
    Placebo
    638.5
    (513.9)
    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
    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

    Outcome Measure Data

    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
    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
    Measure Participants 5 2 5 5
    Niacin FFA AUC
    37567
    (12065)
    164056
    (110047)
    94346
    (42439)
    48870
    (20243)
    Placebo FFA AUC
    106047
    (37010)
    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
    3. Secondary Outcome
    Title Growth Hormone-releasing Hormone (GHRH) Area Under the Curve in Response to Niacin and Placebo Over 4 Hours
    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

    Outcome Measure Data

    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
    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
    Measure Participants 5 2 5 5
    Niacin GHRH
    2535
    (898.2)
    2415
    (129.9)
    2548
    (637.5)
    5382
    (8090.1)
    Placbo GHRH
    2283
    (1505.6)
    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
    Statistical Test of Hypothesis p-Value 0.543
    Comments
    Method ANOVA
    Comments
    4. Secondary Outcome
    Title Somatostatin (SST) Area Under the Curve in Response to Niacin and Placebo Over 4 Hours
    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

    Outcome Measure Data

    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
    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
    Measure Participants 5 0 5 5
    Niacin Somatostatin
    1329
    (615.7)
    849.8
    (484.5)
    1578
    (692.1)
    Placebo Somatostatin
    1248
    (461.5)
    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
    Statistical Test of Hypothesis p-Value .113
    Comments
    Method ANOVA
    Comments

    Adverse Events

    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
    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 (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/5 (0%) 0/2 (0%) 0/5 (0%) 0/5 (0%)
    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%) 0/2 (0%) 0/5 (0%) 0/5 (0%)
    Other (Not Including 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 3/5 (60%) 0/2 (0%) 1/5 (20%) 3/5 (60%)
    Gastrointestinal disorders
    Nausea 3/5 (60%) 8 0/2 (0%) 0 1/5 (20%) 3 3/5 (60%) 9

    Limitations/Caveats

    [Not Specified]

    More Information

    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
    Email yanovskj@mail.nih.gov
    Responsible Party:
    Jack Yanovski, M.D., Chief, Section on Growth and Obesity, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
    ClinicalTrials.gov Identifier:
    NCT01237041
    Other Study ID Numbers:
    • 110004
    • 11-CH-0004
    First Posted:
    Nov 9, 2010
    Last Update Posted:
    Dec 17, 2018
    Last Verified:
    Dec 1, 2018