Dexamethasone Treatment of Congenital Adrenal Hyperplasia

Completed · Phase 2

Conditions studied: Adrenal Hyperplasia, Congenital

In brief

The purpose of this study is to determine if dexamethasone given at night is a more effective treatment for congenital adrenal hyperplasia in young children than standard three times per day hydrocortisone. Our hypothesis is that nocturnal dexamethasone will lead to more efficient suppression of the hypothalamic-pituitary-adrenal axis. We performed a cross-over trial comparing hormonal control during two 24-hour hospitalizations, one on hydrocortisone and one on nocturnal dexamethasone.

Key facts

Study ID

NCT00621985

Run by

Boston Children's Hospital

People needed

5

Starts

2008-04-01

Expected to finish

2009-06-01

Last updated by the study team

2011-02-23

Who can join

Age: 2 and older, up to 9. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Classic salt-wasting 21-hydroxylase deficient congenital adrenal hyperplasia
• Pre-pubertal children with bone ages below 8 years

You may not qualify if…

• Age less than 2 years
• Patients with additional medical conditions necessitating glucocorticoid therapy.
• Patients on phenytoin, barbiturates, and rifampin as these medications accelerate the metabolism of glucocorticoids.
• Patients on ketoconazole as this medication increases the bioavailability of glucocorticoids.

Where it is running

• Children's Hospital Boston — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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