Comparison of 2 and 4 doses hydrocortison substitution with regard to plasma concentration and quality of life. - CHEQ

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-001768-30-SE

Enrollment

Registered

2005-12-07

Start date

2006-01-04

Completion date

Unknown

Last updated

2012-03-19

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

Conditions

We aim to study patients with cortisol deficiency caused by primary adrenal insufficiency (Addison’s disease of autoimmune origin).

Interventions

Product Name: Hydrocortisone Pharmaceutical Form: Capsule* Pharmaceutical form of the placebo: Capsule* Route of administration of the placebo: Oral use

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Cortisol plasma level 300 ng/L 3) Age > 18 years 4) Informed concent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1) Chronic severe disease with risk of deterioration that can influence the cortisol substitution program 2) Chronic drug abuse 3) suspicion of non compliance

Design outcomes

Primary

Measure	Time frame
Main Objective: To study the effects of two different dosing schemes of hydrocortisone on circulating levels of ACTH and cortisol. ;Secondary Objective: To investigate if interleukin-6 could be used as a marker for the anti inflammatory cortisol effect. To investigate if quality of life differs between the two schemes used with regard to fatigue and sleep behaviour. ;Primary end point(s): In a crossover design, six patients are randomised to start treatment with hydrocortisone 20 mg at 0700 hours and 10 mg at 1600 hours. The other six patients start treatment with 10 mg at 0700 hours, 10 mg at 1200 hours, 5 mg at 1600 and 5 mg at 2200 hours. After one month of treatment the patients will switch to the other regimen for one additional month. During the two-dose regimen the patients will receive placebo at 1200 hours and at 2200 hours. At the end of each treatment period, the patients will fill out a quality of life assessment form, which include specific questions regarding morning fatigue. The primary endpoint is ACTH-measurements in the morning before intake of hydrocortisone. Secondary endpoints are morning levels of IL-6 , morning fatigue and sleeping behaviour.	—

Measure

Time frame

Main Objective: To study the effects of two different dosing schemes of hydrocortisone on circulating levels of ACTH and cortisol. ;Secondary Objective: To investigate if interleukin-6 could be used as a marker for the anti inflammatory cortisol effect. To investigate if quality of life differs between the two schemes used with regard to fatigue and sleep behaviour. ;Primary end point(s): In a crossover design, six patients are randomised to start treatment with hydrocortisone 20 mg at 0700 hours and 10 mg at 1600 hours. The other six patients start treatment with 10 mg at 0700 hours, 10 mg at 1200 hours, 5 mg at 1600 and 5 mg at 2200 hours. After one month of treatment the patients will switch to the other regimen for one additional month. During the two-dose regimen the patients will receive placebo at 1200 hours and at 2200 hours. At the end of each treatment period, the patients will fill out a quality of life assessment form, which include specific questions regarding morning fatigue. The primary endpoint is ACTH-measurements in the morning before intake of hydrocortisone. Secondary endpoints are morning levels of IL-6 , morning fatigue and sleeping behaviour.

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Countries

Sweden

Outcome results

None listed

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