Clinical Trial: Dexamethasone Treatment of Congenital Adrenal Hyperplasia

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Dexamethasone Treatment of Congenital Adrenal Hyperplasia

Brief 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.

Detailed Summary: This is a Phase II clinical trial, intended to estimate the effect of instituting Dexamethasone therapy in comparison to prior standard therapy. Each subject provides his own baseline data. There is no control group. Patients with CAH who meet inclusion criteria will be admitted to the clinical research center for two 24 hour hospitalizations. Adrenal hormone profiles will be measured during each hospitalization. The patient will take his or her baseline hydrocortisone regimen during one hospitalization and a new regimen consisting of a single daily nocturnal dose of Dexamethasone during the second hospitalization.
Sponsor: Boston Children’s Hospital

Current Primary Outcome: Percent Difference in the Mean Log Transformed Area Under the Curve of 17-hydroxyprogesterone Between Regimens [ Time Frame: 23 hours ]

Each subject was admitted for 2 24 hour hospitalizations, one on hydrocortisone and one on dexamethasone. Due to the timing of blood draws, the serum hormonal profile was only measured for 23 hours. The primary outcome was the Percent Difference in the Mean log transformed Area under the curve of 17-hydroxyprogesterone between the two regimens.


Original Primary Outcome: Area under the curve of 17 hydroxyprogesterone as measured via frequent lab draws in a 24 hour period. [ Time Frame: 24 hour inpatient stay ]

Current Secondary Outcome:

Original Secondary Outcome: Area under the curve of ACTH as measured via frequent lab draws during a 24 hour period [ Time Frame: 24 hour inpatient stay ]

Information By: Boston Children’s Hospital

Dates:
Date Received: February 11, 2008
Date Started: April 2008
Date Completion:
Last Updated: January 26, 2011
Last Verified: January 2011