Dexamethasone Treatment of Congenital Adrenal Hyperplasia

• Status: Completed
• Trial end date: 2009-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boston Children's Hospital; Boston Children’s Hospital
• Treatments: BB 1101; Cortisol succinate; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Hydrocortisone; Hydrocortisone 17-butyrate 21-propionate; Hydrocortisone acetate

Criteria

Inclusion Criteria:

• Classic salt-wasting 21-hydroxylase deficient congenital adrenal hyperplasia

• Pre-pubertal children with bone ages below 8 years

Exclusion Criteria:

• 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.