Dexamethasone Treatment of Congenital Adrenal Hyperplasia - Full Text View

Sponsored by:	Children's Hospital Boston
Information provided by:	Children's Hospital Boston
ClinicalTrials.gov Identifier:	NCT00621985

Purpose

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.

Condition	Intervention	Phase
Adrenal Hyperplasia, Congenital	Drug: dexamethasone	Phase II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Crossover Assignment
Official Title:	Dexamethasone Treatment of Congenital Adrenal Hyperplasia

Resource links provided by NLM:

Genetics Home Reference related topics: 21-hydroxylase deficiency

Drug Information available for: Dexamethasone Dexamethasone acetate Doxiproct plus Dexamethasone Sodium Phosphate

U.S. FDA Resources

Further study details as provided by Children's Hospital Boston:

Primary Outcome Measures:

Area under the curve of 17 hydroxyprogesterone as measured via frequent lab draws in a 24 hour period. [ Time Frame: 24 hour inpatient stay ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Area under the curve of ACTH and Androstenedione as measured via frequent lab draws during a 24 hour period [ Time Frame: 24 hour inpatient stay ] [ Designated as safety issue: No ]

Enrollment:	5
Study Start Date:	February 2008
Study Completion Date:	June 2009
Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Experimental Experimental therapy with nocturnal dexamethasone.	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.

Detailed 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 GCRC 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.

Eligibility

Ages Eligible for Study:	2 Years to 9 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00621985

Locations

United States, Massachusetts
Children's Hospital Boston
Boston, Massachusetts, United States, 02115

Sponsors and Collaborators

Children's Hospital Boston

Investigators

Principal Investigator:

Joseph Majzoub, MD

Children's Hospital Boston

More Information

No publications provided

Responsible Party:	Children's Hospital Boston ( Joseph Majzoub )
Study ID Numbers:	08-01-0025
Study First Received:	February 11, 2008
Last Updated:	August 3, 2009
ClinicalTrials.gov Identifier:	NCT00621985 History of Changes
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Anti-Inflammatory Agents
Dexamethasone
Hydrocortisone
Gonadal Disorders
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Adrenal Gland Diseases
Adrenogenital Syndrome
Antiemetics
Sex Differentiation Disorders
Adrenocortical Hyperfunction
Hormones
Metabolism, Inborn Errors
Adrenal Hyperplasia

Adrenal Hyperplasia, Congenital
Epinephrine
Metabolic Disorder
Dexamethasone acetate
Metabolic Diseases
Antineoplastic Agents, Hormonal
Cortisol succinate
Endocrine System Diseases
Glucocorticoids
Hyperplasia
Genetic Diseases, Inborn
Endocrinopathy
Hydrocortisone acetate
Peripheral Nervous System Agents

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Dexamethasone
Antineoplastic Agents
Gonadal Disorders
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Adrenal Gland Diseases
Adrenogenital Syndrome
Antiemetics
Sex Differentiation Disorders
Adrenocortical Hyperfunction
Hormones
Metabolism, Inborn Errors
Pathologic Processes
Therapeutic Uses

Adrenal Hyperplasia, Congenital
Steroid Metabolism, Inborn Errors
Dexamethasone acetate
Metabolic Diseases
Antineoplastic Agents, Hormonal
Gastrointestinal Agents
Endocrine System Diseases
Glucocorticoids
Pharmacologic Actions
Hyperplasia
Genetic Diseases, Inborn
Autonomic Agents
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 04, 2009