Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03709381 · ClinicalTrials.gov registry record · Early Phase 1
Effect of Adrenocorticotropic Hormone on Vascular Endothelial Growth Factor Release in Children Study
A Early Phase 1 study, sponsored by Nationwide Children's Hospital.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 10
- Enrollment target
NCT03709381 is a Early Phase 1 study that has completed, run by Nationwide Children's Hospital. The registered enrollment target is 10 participants.
The verdict
NCT03709381, a Early Phase 1 study, has completed, sponsored by Nationwide Children's Hospital.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 10 participants
- Enrollment target
Study Summary
Bone disease and adrenal suppression are two of the many side effects of steroid use in pediatrics. Evidence has shown that adrenocorticotropic hormone (ACTH) protects against the adverse bone effects of steroids in animals and in vitro models, but this has not yet been evaluated in humans. The proposed mechanism in these studies is that ACTH stimulates osteoblasts in bone to release Vascular Endothelial Growth Factor (VEGF), which increases the vascularity in high risk areas of bone. This can potentially be protective against osteonecrosis and osteopenia, which can lead to bone fractures if not prevented. The VEGF release can also be used to demonstrate that an administration of exogenous ACTH occurred. This could be important in diagnosing adrenal insufficiency (AI). One of the tests to assess central AI is the low-dose ACTH stimulation test (LDAST). This test has a high rate of false positive results due to technical limitations. However, if an ACTH-stimulated VEGF level can be measured during the test as a marker of the test being done properly, it will allow for proper interpretation of the results (and identification of a false positive), which will reduce the number of patients being incorrectly diagnosed with central AI. This study will recruit ten healthy children and adolescents, ages 9-18, to assess the effects of ACTH on VEGF levels. The investigators will measure the response of VEGF and cortisol to an administration of a low dose and high dose of cosyntropin (the synthetic ACTH analog used in this test). The hypothesis of this study is that VEGF and cortisol will both increase after administration of cosyntropin. At this time, no other studies have demonstrated that VEGF is responsive to ACTH in humans. If the hypothesis is correct, the results will have two main implications. VEGF can be used as a marker of ACTH administration during the LDAST to identify false positive tests. Secondly, this will help further research into whether ACTH can be used to
Interventions
- DRUG Low Dose Cosyntropin (ACTH) stimulation test
- DRUG High Dose Cosyntropin (ACTH) stimulation test
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2017-10-01 |
| Est. Completion | 2019-01-31 |
| Phase | Early Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03709381
The ClinicalTrials.gov registry entry for NCT03709381 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Nationwide Children's Hospital, which has 188 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Low Dose Cosyntropin (ACTH) stimulation test is the first listed.
NCT03709381 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03709381 about?
NCT03709381 is a clinical study titled "Effect of Adrenocorticotropic Hormone on Vascular Endothelial Growth Factor Release in Children Study". Bone disease and adrenal suppression are two of the many side effects of steroid use in pediatrics. Evidence has shown that adrenocorticotropic hormone (ACTH) protects against the adverse bone effects of steroids in animals and in vitro models, but this has not yet been evaluated in humans. The prop...
What is the current status of trial NCT03709381?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 10 participants. The study started on 2017-10-01. Estimated completion is 2019-01-31.
What interventions are being tested in trial NCT03709381?
The interventions under investigation include: Low Dose Cosyntropin (ACTH) stimulation test (DRUG), High Dose Cosyntropin (ACTH) stimulation test (DRUG).
Who is sponsoring clinical trial NCT03709381?
This trial is sponsored by Nationwide Children's Hospital, which has 188 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.