NCT04293133

Brief Summary

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.

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
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2020

Shorter than P25 for all trials

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 2, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 3, 2020

Completed
8 days until next milestone

Study Start

First participant enrolled

March 11, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 11, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 11, 2020

Completed
Last Updated

March 3, 2020

Status Verified

March 1, 2020

Enrollment Period

5 months

First QC Date

March 2, 2020

Last Update Submit

March 2, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Final height in patients with congenital adrenal hyperplasia

    Target height(TH) will be calculated using the formula: \[maternal height + paternal height - 13 cm for girls and + 13 cm for boys\]/2

    Baseline

Eligibility Criteria

AgeUp to 18 Years
Sexall
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients having a documented history of classical CAH.

You may qualify if:

  • Patients having a documented history of classical CAH.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Cole TJ, Freeman JV, Preece MA. Body mass index reference curves for the UK, 1990. Arch Dis Child. 1995 Jul;73(1):25-9. doi: 10.1136/adc.73.1.25.

    PMID: 7639544BACKGROUND
  • Charmandari E, Brook CG, Hindmarsh PC. Classic congenital adrenal hyperplasia and puberty. Eur J Endocrinol. 2004 Nov;151 Suppl 3:U77-82. doi: 10.1530/eje.0.151u077.

    PMID: 15554890BACKGROUND

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

Study Officials

  • Rana Ahmed

    Ain Shams University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Final height in patients with congenital adrenal hyperplasia

Study Record Dates

First Submitted

March 2, 2020

First Posted

March 3, 2020

Study Start

March 11, 2020

Primary Completion

August 11, 2020

Study Completion

September 11, 2020

Last Updated

March 3, 2020

Record last verified: 2020-03