Status:
UNKNOWN
Determining the Long-Term Effects of Prenatal Dexamethasone Treatment in Children With 21-Hydroxylase Deficiency and Their Mothers
Lead Sponsor:
Office of Rare Diseases (ORD)
Conditions:
Adrenal Hyperplasia, Congenital
Eligibility:
All Genders
12+ years
Brief Summary
Congenital adrenal hyperplasia (CAH) is a genetic disorder that affects the amount of steroids that the body forms. The most common form of CAH is 21-hydroxylase deficiency (21OHD), which leads to cor...
Detailed Description
CAH is a genetic steroidogenesis disorder. The most common form, 21OHD, leads to cortisol deficiency and, in turn, an excess of androgen, a hormone that promotes the development and maintenance of mal...
Eligibility Criteria
Inclusion
- For all participants:
- English-speaking
- Has undergone DNA testing for mutations in the CYP21A2 gene
- For children who received prenatal dexamethasone treatment:
- Genetic confirmation of 21OHD diagnosis
- Received full or partial prenatal dexamethasone treatment
- For children in the control group:
- Did not receive prenatal dexamethasone treatment
- For mothers:
- History of at-risk pregnancy for a fetus affected with 21OHD
- Genetic confirmation of child's diagnosis
Exclusion
- Any mental disorder that could prevent understanding of study materials
- Current or past steroid use for reasons other than CAH (i.e., asthma, lupus, rheumatoid arthritis)
Key Trial Info
Start Date :
January 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 1 2009
Estimated Enrollment :
233 Patients enrolled
Trial Details
Trial ID
NCT00617292
Start Date
January 1 2008
End Date
July 1 2009
Last Update
December 9 2008
Active Locations (4)
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1
Mount Sinai School of Medicine
New York, New York, United States, 10029
2
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
3
University of Sao Paolo
São Paulo, São Paulo, Brazil
4
University of Lyon
Lyon, France