Linear Growth of Children With Congenital Adrenal Hyperplasia

September 10, 2019 updated by: Ali Hussin Mohamed, Assiut University

Linear Growth of Children With Congenital Adrenal Hyperplasia.

The congenital adrenal hyperplasias (CAHs) comprise a family of autosomal recessive disorders that disrupt adrenal steroidogenesis. Three specific enzyme deficiencies are associated with virilization of affected women. The most common form is 21-hydroxylase deficiency (21-OHD) due to mutations in the 21-hydroxylase (CYP21A2) gene. Other virilizing forms include 3b-hydroxysteroid dehydrogenase type 2 (HSD3B2) and 11b-hydroxylase deficiencies associated with mutations in the HSD3B2 and 11b-hydroxylase (CYP11B1) genes, respectively.

Study Overview

Status

Unknown

Conditions

Detailed Description

It has been reported that approximately one child in every 18000 born in Great Britain has CAH. In North America, the incidence varies from 1:15000 to 1:16000. The reported rates of CAH have been as high as 1:280 among the Yupik people of Alaska and 1:2100 on the French island of Réunion in Indian ocean; both of these populations are geographically isolated. The reported incidence of CAH in the two Brazilian states that have routinely included CAH in their public newborn screening programs is 1:11655 in the South (Santa Catarina) and 1:10325 in Midwest (Goiás).

Salt-losing CAH accounts for about three quartes of cases reported and non-salt losing CAH for one quarter. Non-classic is more common ;Estimated as 1 in 1000-2000 in white populations. It is more frequent in certain ethnic groups, such as the Ashkenazi Jewish population. The mild non-classic form is a common cause of hyperandrogenism.

Treatment of classic 21-OHD consists of replacement doses of gluco- (GC) and mineralocorticoids aiming to reduce excess androgen, and to allow adequate linear growth. However, several series report that growth in these children is below expectation, as compared with both the reference population and the target height (TH).

The reasons for the inadequate growth and impairment of the final height (FH) are not completely understood. A major cause is the difficulty in accomplishing a fine balance between inhibition of excess androgen production which accelerates bone maturation and adequate GC replacement itself which even at slightly supraphysiologic doses can be deleterious to growth.

Study Type

Observational

Enrollment (Anticipated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

• pediatric patients with congenital adrenal hyperplasia who are taking glucocorticoid replacement therapy and attending Endocrine unit of Assiut University Children Hospital within one year.

Description

Inclusion criteria:

  • Age: 1-18 y.
  • Both sexes.
  • All patients who were diagnosed as having CAH of at least 1 y duration.
  • On glucocorticoid replacement therapy .

Exclusion criteria:

  • Patients diagnosed as CAH for less than 1 year duration.
  • Patients with deficient data at the time of diagnosis.
  • Patients missed for follow up.
  • Syndromatic patients.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
patients
patients who were diagnosed as having CAH of at least 1 y duration. and On glucocorticoid replacement therapy .
controls
A comparable number of age and sex matched apparently normal children will be included as control.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
factors affecting linear growth in children with CAH.
Time Frame: 6 months
by using appropriate growth charts and doing follow up wrist x-ray .
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

September 24, 2019

Primary Completion (ANTICIPATED)

October 24, 2020

Study Completion (ANTICIPATED)

October 24, 2021

Study Registration Dates

First Submitted

September 10, 2019

First Submitted That Met QC Criteria

September 10, 2019

First Posted (ACTUAL)

September 12, 2019

Study Record Updates

Last Update Posted (ACTUAL)

September 12, 2019

Last Update Submitted That Met QC Criteria

September 10, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GCAH

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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