A randomized double blind cross-over trial of the effects of low dose and high dose hydrocortisone replacement therapy on cognition, quality of life, metabolic profile and somatosensation in patients with secondary adrenal insufficiency

A randomized double blind cross-over trial of the effects of low dose and high dose hydrocortisone replacement therapy on cognition, quality of life, metabolic profile and somatosensation in patients with secondary adrenal insufficiency - Hydrocortisone replacement in patients with adrenal insufficiency.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON38411

Enrollment

Registered

2011-11-22

Start date

2012-05-10

Completion date

Unknown

Last updated

2024-04-29

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

Conditions

adrenal insufficiency secondary adrenal insufficiency

Interventions

Patients receive either a low dose HC (0.2-0.3 mg/kg body weight) for 10 weeks followed by 10 weeks of high dose HC (0.4-0.6 mg/kg body weight) or high dose HC followed by a low dose of HC.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patients with secondary adrenal insufficiency Age >= 18 - 75 years >= One year after tumor treatment with surgery and/or radiotherapy On stable concomitant medications for at least six months prior to entry of study Body weight 50-100 kg

Exclusion criteria

Exclusion criteria: Inability of legal consent Documented cognitive impairment Drug abuse/dependence History of psychiatric disorders Use of anti-epileptics (e.g. carbamezapine) Cushings disease Type 1 or Type 2 diabetes Current treatment for second malignancy

Design outcomes

Primary

Measure	Time frame
The primary endpoint is cognitive performance.	—

Secondary

Measure	Time frame
The secondary endpoints are quality of life, metabolic profile and somatosensation.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)