Dexamethasone Treatment of Congenital Adrenal Hyperplasia

Adrenal Hyperplasia, Congenital Clinical Trial

Official title:

Dexamethasone Treatment of Congenital Adrenal Hyperplasia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00621985
• Other study ID #: 08-01-0025
• Status: Completed
• Phase: Phase 2
• First received: February 11, 2008
• Last updated: January 26, 2011
• Start date: April 2008
• Est. completion date: June 2009

Study information

• Verified date: January 2011
• Source: Children's Hospital Boston
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 9 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adrenal Hyperplasia, Congenital
• Adrenocortical Hyperfunction
• Adrenogenital Syndrome
• Hyperplasia

Intervention

Drug:
• dexamethasone
Dexamethasone will be given at a dose that equals 1/50 of the total daily hydrocortisone dose of the patient. It will be given in solution form at 10 PM for 3 days.
• Hydrocortisone
Subjects were given their baseline hydrocortisone regimen which was three times daily for 4 of the subjects and twice daily for one subject. Doses were given at 8 AM, 2 PM, and 8 PM. The 2 PM time point was skipped for the subject who received hydrocortisone twice daily. Doses ranged from 6.9 to 18.5 milligrams per meter squared per day and were based on each individual's baseline regimen.

Locations

Country	Name	City	State
United States	Children's Hospital Boston	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital Boston

Country where clinical trial is conducted

United States, 

References & Publications (1)

Dauber A, Feldman HA, Majzoub JA. Nocturnal Dexamethasone versus Hydrocortisone for the Treatment of Children with Congenital Adrenal Hyperplasia. Int J Pediatr Endocrinol. 2010;2010. pii: 347636. doi: 10.1155/2010/347636. Epub 2010 Sep 14. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent Difference in the Mean Log Transformed Area Under the Curve of 17-hydroxyprogesterone Between Regimens	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.	23 hours	No