CClinicalTrials.gg
Status unknownNCT04087148Updated Sep 12, 2019

Linear Growth of Children With Congenital Adrenal Hyperplasia

An observational study in Congenital Adrenal Hyperplasia, sponsored by Assiut University. Status unknown. Open to participants aged 1 Year to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-09-12.

Sponsored by Assiut University · Observational

The sponsor has not verified this record recently (last verified Sep 2019), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
60
Ages
1 Year to 18 Years
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

03

Who can participate

Ages eligible
1 Year to 18 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
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.

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

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.
04

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
60 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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.

05

What researchers measure

Primary outcomes

  1. factors affecting linear growth in children with CAH.

    by using appropriate growth charts and doing follow up wrist x-ray .

    Time frame: 6 months

06

Study locations

No study locations are listed for this record.

07

References and documents

Publications

  • Delle Piane L, Rinaudo PF, Miller WL. 150 years of congenital adrenal hyperplasia: translation and commentary of De Crecchio's classic paper from 1865. Endocrinology. 2015 Apr;156(4):1210-7. doi: 10.1210/en.2014-1879. Epub 2015 Jan 30. PubMed 25635623 ↗
  • Silveira EL, dos Santos EP, Bachega TA, van der Linden Nader I, Gross JL, Elnecave RH. The actual incidence of congenital adrenal hyperplasia in Brazil may not be as high as inferred--an estimate based on a public neonatal screening program in the state of Goias. J Pediatr Endocrinol Metab. 2008 May;21(5):455-60. doi: 10.1515/jpem.2008.21.5.455. PubMed 18655527 ↗
  • Nunes AK, Wachholz RG, Rover MR, Souza LC. [Prevalence of disorders detected by newborn screening in Santa Catarina]. Arq Bras Endocrinol Metabol. 2013 Jul;57(5):360-7. doi: 10.1590/s0004-27302013000500005. Portuguese. PubMed 23896802 ↗
  • Trapp CM, Oberfield SE. Recommendations for treatment of nonclassic congenital adrenal hyperplasia (NCCAH): an update. Steroids. 2012 Mar 10;77(4):342-6. doi: 10.1016/j.steroids.2011.12.009. Epub 2011 Dec 13. PubMed 22186144 ↗
  • Nebesio TD, Eugster EA. Growth and reproductive outcomes in congenital adrenal hyperplasia. Int J Pediatr Endocrinol. 2010;2010:298937. doi: 10.1155/2010/298937. Epub 2010 Feb 1. PubMed 20148087 ↗

Individual participant data

Plan to share: Undecided

08

Registry details

Key details

Study ID
NCT04087148
Lead sponsor
Assiut University
Responsible party
Ali Hussin Mohamed (principal Investigator, Assiut University) — Principal investigator
First posted
Sep 12, 2019
Start date
Sep 24, 2019 (estimated)
Primary completion
Oct 24, 2020 (estimated)
Completion
Oct 24, 2021 (estimated)
Last update
Sep 12, 2019

Study contacts

Hanaa Abdellatef Mohammad, Professor of pediatrics
Contact
hae50@aun.edu.eg
01064747613
Faisal Al_khateeb Ahmed, Assistant professor
Contact
faisalalkhateeb@aun.edu.eg
01003856676

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.

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