NCT04087148

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2019

Typical duration for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 10, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 12, 2019

Completed
12 days until next milestone

Study Start

First participant enrolled

September 24, 2019

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 24, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 24, 2021

Completed
Last Updated

September 12, 2019

Status Verified

September 1, 2019

Enrollment Period

1.1 years

First QC Date

September 10, 2019

Last Update Submit

September 10, 2019

Conditions

Congenital Adrenal Hyperplasia

Outcome Measures

Primary Outcomes (1)

  • factors affecting linear growth in children with CAH.

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

    6 months

Study Arms (2)

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.

Eligibility Criteria

Age1 Year - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability 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.

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • 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.

    PMID: 25635623BACKGROUND

  • 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.

    PMID: 18655527BACKGROUND

  • 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.

    PMID: 23896802BACKGROUND

  • 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.

    PMID: 22186144BACKGROUND

  • 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.

    PMID: 20148087BACKGROUND

MeSH Terms

Conditions

Adrenal Hyperplasia, Congenital

Condition Hierarchy (Ancestors)

Adrenogenital SyndromeDisorders of Sex DevelopmentUrogenital AbnormalitiesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesGenetic Diseases, InbornSteroid Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsMetabolic DiseasesNutritional and Metabolic DiseasesAdrenal Gland DiseasesEndocrine System DiseasesGonadal Disorders

Central Study Contacts

Hanaa Abdellatef Mohammad, Professor of pediatrics

CONTACT

01064747613hae50@aun.edu.eg

Faisal Al_khateeb Ahmed, Assistant professor

CONTACT

01003856676faisalalkhateeb@aun.edu.eg

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal Investigator

Study Record Dates

First Submitted

September 10, 2019

First Posted

September 12, 2019

Study Start

September 24, 2019

Primary Completion

October 24, 2020

Study Completion

October 24, 2021

Last Updated

September 12, 2019

Record last verified: 2019-09