Effect of Supplemental Hydrocortisone During Stress in Prednisolone-induced Adrenal Insufficiency
Recruiting now · Phase 4 · Has a placebo group
Conditions studied: Adrenal Insufficiency, Polymyalgia Rheumatica, Giant Cell Arteritis
In brief
In this double-blinded randomised placebo-controlled clinical trial, the aim is to determine the effect of supplemental hydrocortisone compared with placebo during mild to moderate physical or mental stress on health related quality of life in patients with polymyalgia rheumatica (PMR)/giant cell arteritis (GCA) on ongoing low-dose prednisolone diagnosed with glucocorticoid-induced adrenal insufficiency. The main emphasis is on fatigue (primary outcome) and daily variation hereof during periods of stress.
Key facts
- Study ID
- NCT05435781
- Run by
- Marianne Christina Klose
- People needed
- 250
- Starts
- 2022-06-07
- Expected to finish
- 2028-03-01
- Last updated by the study team
- 2026-03-16
Who can join
Age: 50 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age ≥ 50 years
- Women must be postmenopausal (FSH is measured at the screening visit)
- A diagnosis of PMR/GCA, or both conditions combined.
- Treatment with prednisolone ≥12 weeks
- Ongoing prednisolone treatment, with current daily prednisolone dose > 0 mg and ≤5 mg. The dose must have been ≤5 mg for minimum 2 weeks at the time of the screening visit.
You may not qualify if…
- Known primary or secondary adrenal insufficiency
- Known Cushing's Syndrome
- Known allergy towards study medication ingredients
- Severe comorbidity: Heart failure (New York Heart Association class IV); Kidney failure with an estimated glomerular filtration rate <30 mL/min (Chronic kidney disease stage 4-5); Liver disease in the form of cirrhosis; Active cancer; Known severe immune deficiency; A history of psychiatric disease requiring treatment by a psychiatric department (for affective disorders only if within the last year before study entry)
- Alcohol consumption >21 units per week
- Planned major surgery during the study period at study entry.
- Use of drugs that interfere with cortisol metabolism/measurements: Systemic oestrogen treatment (discontinued < 1 month before inclusion), Treatment with strong CYP3A4 inhibitors or inducers, Use of other glucocorticoid formulations (Inhaled corticosteroids, intraarticular or intramuscular injections, steroid creams European steroid group IV-V used in the genital area. Note: Permitted glucocorticoid formulations: Eye-drops, nasal spray, glucocorticoid creams European steroid group I-III, and European steroid group IV-V used in the non-genital area only.)
- Inability to provide written informed consent.
Where it is running
- Department of Endocrinology, Odense University Hospital — Odense, Denmark (enrolling)
- Department of Endocrinology, Aarhus University Hospital — Aarhus, Denmark (enrolling)
- Department of Medical Endocrinology, Copenhagen University Hospital, Rigshospitalet — Copenhagen, Denmark (enrolling)
Full record on ClinicalTrials.gov
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