Avoiding over and undertreatment by optimizing of the timing of glucocorticoïd treatment in children with cnogenital adrenal hyperplasia

Optimizing timing of glucocorticoid treatment in children with congenital adrenal hyperplasia - OPTIMED study

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-004802-24-NL

Enrollment

Registered

2019-05-13

Start date

2019-05-20

Completion date

Unknown

Last updated

2020-11-23

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

Conditions

Congenital adrenal hyperplasia (CAH) is a disorder of adrenal steroid synthesis leading to cortisol deficiency and an increase in androgen production.Treatment in children consists of hydrocortisone substitution thereby also restoring the negative feedback on the pituitary gland and consequently normalize androgen production. There is still no evidence about the best timing of hydrocortisone use: The highest dosage of hydrocortisone in the morning or the highest dosage at night

Interventions

Product Name: Hydrocortisone Pharmaceutical Form: Tablet INN or Proposed INN: Hydrocortisone Other descriptive name: HYDROCORTISONE Concentration unit: mg milligram(s) Concentration type: range Concen

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Children with CAH due to 21-hydroxylase deficiency > 4 years old and =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: •Other forms of CAH •Not able to collect saliva •Chronical medication use other than hydrocortisone and fludrocortisone

Design outcomes

Secondary

Measure	Time frame
Secondary end point(s): 12 hour blood pressure and sleeping patterns during the 2 treatment strategies.;Timepoint(s) of evaluation of this end point: daily sleeping score RR once after every 3 week period	—

Primary

Measure	Time frame
Main Objective: To study the effects of 2 standard treatment timing strategies for glucocorticoid dosage on androgen concentration in CAH children: a. highest dosage in the morning, b. highest dosage in the evening.;Secondary Objective: 12 hours blood pressure and activity and sleeping patterns during the 2 treatment strategies.;Primary end point(s): 17-hydroxyprogesterone and androstenedione levels measured in saliva four times a day after 3 weeks of treatment with the 2 different timing strategies. We will compare differences in levels of 17 OHP and A. between the 2 dose schedules.;Timepoint(s) of evaluation of this end point: at the end of each 3 week period	—

Measure

Time frame

Main Objective: To study the effects of 2 standard treatment timing strategies for glucocorticoid dosage on androgen concentration in CAH children: a. highest dosage in the morning, b. highest dosage in the evening.;Secondary Objective: 12 hours blood pressure and activity and sleeping patterns during the 2 treatment strategies.;Primary end point(s): 17-hydroxyprogesterone and androstenedione levels measured in saliva four times a day after 3 weeks of treatment with the 2 different timing strategies. We will compare differences in levels of 17 OHP and A. between the 2 dose schedules.;Timepoint(s) of evaluation of this end point: at the end of each 3 week period

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Countries

Netherlands

Contacts

Public ContactDepartment of Ped Endocrinology

Radboud University Nijmegen medical centre

hedi.claahsen@radboudumc.nl+31243614430

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026