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Dexamethasone Treatment of Congenital Adrenal Hyperplasia

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ClinicalTrials.gov Identifier: NCT00621985
Recruitment Status : Completed
First Posted : February 22, 2008
Results First Posted : February 23, 2011
Last Update Posted : February 23, 2011
Sponsor:
Information provided by:
Boston Children’s Hospital

Tracking Information
First Submitted Date  ICMJE February 11, 2008
First Posted Date  ICMJE February 22, 2008
Results First Submitted Date  ICMJE September 17, 2010
Results First Posted Date  ICMJE February 23, 2011
Last Update Posted Date February 23, 2011
Study Start Date  ICMJE April 2008
Actual Primary Completion Date June 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 26, 2011)
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 Measures  ICMJE
 (submitted: February 11, 2008)
Area under the curve of 17 hydroxyprogesterone as measured via frequent lab draws in a 24 hour period. [ Time Frame: 24 hour inpatient stay ]
Change History Complete list of historical versions of study NCT00621985 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: February 11, 2008)
Area under the curve of ACTH as measured via frequent lab draws during a 24 hour period [ Time Frame: 24 hour inpatient stay ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Dexamethasone Treatment of Congenital Adrenal Hyperplasia
Official Title  ICMJE 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 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Adrenal Hyperplasia, Congenital
Intervention  ICMJE
  • 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.
    Other Name: Decadron
  • Drug: 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.
Study Arms  ICMJE Experimental: Experimental
Experimental therapy with nocturnal dexamethasone.
Interventions:
  • Drug: dexamethasone
  • Drug: Hydrocortisone
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 3, 2009)
5
Original Estimated Enrollment  ICMJE
 (submitted: February 11, 2008)
10
Actual Study Completion Date  ICMJE June 2009
Actual Primary Completion Date June 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 2 Years to 9 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00621985
Other Study ID Numbers  ICMJE 08-01-0025
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Joseph Majzoub, Children's Hospital Boston
Study Sponsor  ICMJE Boston Children’s Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Joseph Majzoub, MD Boston Children’s Hospital
PRS Account Boston Children’s Hospital
Verification Date January 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP