Dexamethasone Treatment of Congenital Adrenal Hyperplasia

This study has been completed.

Study NCT00621985 Information provided by Children's Hospital Boston

First Received on February 11, 2008. Last Updated on January 26, 2011 History of Changes

Results First Received: September 17, 2010

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Intervention Model: Crossover Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Adrenal Hyperplasia, Congenital
Interventions:	Drug: dexamethasone Drug: Hydrocortisone

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects were recruited from the Endocrine Clinic at Children's Hospital Boston from April through November 2008.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
This was a cross over study. All subjects were admitted on their baseline hydrocortisone regimen for a 24 hour hospital admission. They then had a second hospital admission within 8 weeks while being administered the dexamethasone therapy.

Reporting Groups

	Description
Experimental	Baseline hydrocortisone was given at a dose determined by the subject's primary endocrinologist and was given either 2 or 3 times per day as per their home regimen. Experimental therapy with nocturnal dexamethasone given at a dose equivalent to 1/50th of the total daily hydrocortisone dose. This dose was given at 10 PM for three nights with the admission to the hospital occurring on the 3rd day prior to the 3rd evening dose.

Description

Experimental

Baseline hydrocortisone was given at a dose determined by the subject's primary endocrinologist and was given either 2 or 3 times per day as per their home regimen. Experimental therapy with nocturnal dexamethasone given at a dose equivalent to 1/50th of the total daily hydrocortisone dose. This dose was given at 10 PM for three nights with the admission to the hospital occurring on the 3rd day prior to the 3rd evening dose.

Participant Flow for 2 periods

Period 1: Hydrocortisone Admission

	Experimental
STARTED	5
COMPLETED	5
NOT COMPLETED	0

Period 2: Dexamethasone Admission

	Experimental
STARTED	5
COMPLETED	4
NOT COMPLETED	1
Adverse Event	1

Baseline Characteristics

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Reporting Groups

	Description
Experimental Group	These subjects were admitted twice, once while on baseline hydrocortisone and once on dexamethasone.

Baseline Measures

	Experimental Group
Number of Participants [units: participants]	5
Age [units: participants]
<=18 years	5
Between 18 and 65 years	0
>=65 years	0
Gender [units: participants]
Female	2
Male	3
Region of Enrollment [units: participants]
United States	5

Outcome Measures

1. Primary:

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

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

All Principal Investigators ARE employed by the organization sponsoring the study.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Joseph Majzoub
Organization: Children's Hospital Boston
phone: 617-355-7476
e-mail: joseph.majzoub@childrens.harvard.edu

Publications of Results:

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. Epub 2010 Sep 14.

Responsible Party:	Joseph Majzoub, Children's Hospital Boston
ClinicalTrials.gov Identifier:	NCT00621985 History of Changes
Other Study ID Numbers:	08-01-0025
Study First Received:	February 11, 2008
Results First Received:	September 17, 2010
Last Updated:	January 26, 2011
Health Authority:	United States: Institutional Review Board