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NCT01237041 · ClinicalTrials.gov registry record · Phase 1
Free Fatty Acids, Body Weight, and Growth Hormones Secretion in Children
A Phase 1 study, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
- Terminated
- Registry status
- Phase 1
- Development phase
- 37
- Enrollment target
NCT01237041: Clinical Trial Phase 1 study, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
NCT01237041 is a Phase 1 study that was terminated before completion, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). The registered enrollment target is 37 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (38% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01237041, a Phase 1 study, was terminated before completion, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 37 participants
- Enrollment target
Study 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
Primary Outcome
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.
Interventions
- DRUG Placebo First
- DRUG Niacin First
- DRUG Dose-Establishing Study 1 Niacin 250mg
- DRUG Dose-Establishing Study 1 Niacin 500mg
- DRUG Dose-Establishing Study 2 Niacin 500mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 37 participants |
| Start Date | 2011-07-01 |
| Est. Completion | 2017-12-13 |
| Phase | Phase 1 |
Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)305 total trials
Why NCT01237041 stopped before completion
NCT01237041 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 37 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (38% lower).
The record links to 0 conditions, and to 5 interventions - of which Placebo First is the first listed.
NCT01237041 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01237041 about?
NCT01237041 is a clinical study titled "Free Fatty Acids, Body Weight, and Growth Hormones Secretion in Children". 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 m...
What is the current status of trial NCT01237041?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 37 participants. The study started on 2011-07-01. Estimated completion is 2017-12-13.
What interventions are being tested in trial NCT01237041?
The interventions under investigation include: Placebo First (DRUG), Niacin First (DRUG), Dose-Establishing Study 1 Niacin 250mg (DRUG), Dose-Establishing Study 1 Niacin 500mg (DRUG), Dose-Establishing Study 2 Niacin 500mg (DRUG).
Who is sponsoring clinical trial NCT01237041?
This trial is sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), which has 305 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01237041's enrollment target sits among peer trials
37 1204th of 2000 higher than 791 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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