Final Height in Patients With CAH

March 2, 2020 updated by: Mohammed Kamel El-Desouky Ashour, Ain Shams University

Final Height in Patients With Congenital Adrenal Hyperplasia

Congenital adrenal hyperplasia (CAH) is the most common inherited disorder in the adrenal gland in children. Growth is usually affected in CAH patients either due to the disease itself or treatment consequences.

Study Overview

Status

Unknown

Conditions

Detailed Description

CAH comprises a group of autosomal recessive disorders caused by a deficiency of one of five enzymes needed for the synthesis of cortisol leading to defect in cortisol synthesis with or without aldosterone deficiency and an increase in the production of adrenocorticotropic hormone through negative feedback.

The most common form is 21-hydroxylase deficiency (21OHD), which forms more than 90 % of the cases.

In classic CAH, 75% of the patients have the salt wasting (SW) and 25% have the non salt-wasting phenotype (NSW).There are no clinical signs at birth in male infants and in female patients, CAH is suspected shortly after birth if there is genital ambiguity, ranging from slight clitromegaly to complete masculinization with acceleration of growth and pubertal development.

The non-classic (late onset) form of CAH is a less severe form of 21OHD, and is diagnosed later in life.

Final height in early and late onset patients has been reported as diminished (Hauffa et al, 1997).This could be attributed to androgen excess or treatment with steroids. Androgen excess can occur at any age leading to accelerated growth, early epiphyseal closure and compromised final adult height.

Despite that all forms of CAH differ in their degree of enzymatic deficiency, they all represent a therapeutic challenge to pediatric endocrinologists attempting to optimize growth.

Study Type

Observational

Enrollment (Anticipated)

30

Contacts and Locations

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

Study Contact

Study Contact Backup

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

No older than 18 years (Child, Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients having a documented history of classical CAH.

Description

Inclusion Criteria:

  • Patients having a documented history of classical CAH.

Exclusion Criteria:

  • Patients with non classical CAH.
  • Patients treated with growth hormone.
  • Chronic use of medications unrelated to CAH which may affect growth like immunosuppressive drugs like azathioprine and drugs that affect growth hormone release like octreotide, pegvisomant, bromocriptine and cabergoline.
  • Other chronic diseases that may affect growth like heart disease, inflammatory bowel disease and renal disease.
  • Other causes of adrenal insufficiency.

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

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Final height in patients with congenital adrenal hyperplasia
Time Frame: Baseline
Target height(TH) will be calculated using the formula: [maternal height + paternal height - 13 cm for girls and + 13 cm for boys]/2
Baseline

Collaborators and Investigators

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

Sponsor

Ain Shams University

Investigators

  • Principal Investigator: Rana Ahmed, Ain shams 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)

March 11, 2020

Primary Completion (Anticipated)

August 11, 2020

Study Completion (Anticipated)

September 11, 2020

Study Registration Dates

First Submitted

March 2, 2020

First Submitted That Met QC Criteria

March 2, 2020

First Posted (Actual)

March 3, 2020

Study Record Updates

Last Update Posted (Actual)

March 3, 2020

Last Update Submitted That Met QC Criteria

March 2, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAH

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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