Novel mass spectrometric monitoring (steroid metabolomics) to detect treatment success and chronic over- or under-treatment in children with CAH (CAH metabolomics).

Novel mass spectrometric monitoring (steroid metabolomics) to detect treatment success and chronic over- or under-treatment in children with CAH (CAH metabolomics). - Novel CAH monitoring tools

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON44301

Enrollment

Registered

2017-12-04

Start date

2018-01-09

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

adrenogenital syndromem congenital adrenal hyperplasia (CAH)

Interventions

None listed

Eligibility

Age

2 Years to 17 Years

Inclusion criteria

Inclusion criteria: The subjects must have a genetically confirmed diagnosis of classical CAH (salt-losing or simple virilising) and - group 1: being pre-pubertal and Tanner stage 1 or - group 2: being late-pubertal and Tanner stage 3 plus or post-menarche The subjects must personally provide, or have a legal guardian provide, written informed consent to participate in the trial, according to local regulations.

Exclusion criteria

Exclusion criteria: - Intercurrent illnesses at or within one week before visit. - Poor understanding of language by subjects and/or legal guardians, leading to insufficient ability to understand the written study information form.

Design outcomes

Primary

Measure	Time frame
The primary endpoint is therapy success, defined as no signs of over- or undertreatment plus absence of adrenal crisis which needs elevated hormonal replacement therapy (e.g. infection)	—

Secondary

Measure	Time frame
The secondary endpoints are signs of over- or undertreatment, as defined in the study protocol table 1.	—

Countries

Netherlands

Outcome results