Effect of Supplemental Hydrocortisone During Stress in Prednisolone-induced Adrenal Insufficiency
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age50+
SponsorMarianne Christina Klose
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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)
Trial design
Treatments tested in this trial
- Hydrocortisone
- Placebo for hydrocortisone
Treatment groups
250 Participants
are divided into 3 treatment groupsSponsors and collaborators
Marianne Christina Klose
Lead sponsor
Rigshospitalet, Denmark
Sponsor institution
Aarhus University Hospital
Collaborator
Odense University Hospital
Collaborator
Source ClinicalTrials.gov