Effect of Adrenocorticotropic Hormone on Vascular Endothelial Growth Factor Release in Children Study

Plain-language guide to NCT03709381: early phase 1 interventional trial of Cosyntropin, 10 participants. Who took part, design and what was measured.

Key Facts

Registry ID: NCT03709381
Phase: early phase 1
Status: completed
Start: 2017-10-01
Completion (planned or actual): 2018-10-31
Participants: 10 (actual)
Design: na, open label (everyone knows who gets what), diagnostic
Conditions studied: Adrenal Insufficiency; Osteopenia, Osteoporosis; Steroid Suppression of ACTH Secretion
Results posted: not yet

What This Study Did, in Plain Language

What Was Tested

The trial (early phase 1) is built around Cosyntropin.

Bone disease and adrenal suppression are two of the many side effects of steroid use in pediatrics.

It had 1 arm (groups): ACTH stim test arm (experimental).

The registry classes the interventions as drug.

More on the Plan

Bone disease, which includes osteopenia, fractures, and osteonecrosis, is very common.

Another common side effect of steroid use is suppression of the HPA axis.

Diagnosing adrenal suppression can be difficult.

Literature exists showing that ACTH can stimulate release of VEGF (in vitro and in animal in vivo studies), which can both be protective against bone disease and be used as a marker of exogenous cosyntropin administration.

Who Took Part

Enrollment: 10 actual participants took part.

It was open to people of any sex aged from 9 years up to 17 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Subjects will be between the ages of 9-18 years old on the day of testing.

The full record lists 1 inclusion and 5 exclusion criteria; among the exclusions: currently taking any medication other than over-the-counter medications (over-the-counter medications will be stopped on the day of the study); steroid use within the prior six months (including iv, oral, inhaled, and intranasal steroids); oral contraceptive pill use within the prior six months.

How the Study Was Run

The set-up was single-group and open-label.

Everyone knew when Cosyntropin was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2017-10-01 with completion listed for 2018-10-31.

It ran at 1 site in United States.

Its stated primary purpose is diagnostic.

What This Means in Plain Language

Put simply, this is a early phase 1 trial of Cosyntropin in 10 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Cosyntropin compound page, all human trials.

Our Notes on the Compound

Cosyntropin: A synthetic 24-amino-acid fragment of ACTH (also tetracosactide, Synacthen) used mainly in the adrenal stimulation test.

Cosyntropin in the library

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.