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Effect of Supplemental Hydrocortisone During Stress in Prednisolone-induced Adrenal Insufficiency

NCT05435781 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2026-03-16

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Hydrocortisone

Patients are randomised to either placebo or hydrocortisone supplemental doses in situations of stress. Patients will continue prednisolone treatment and tapering hereof according to current clinical guidelines for PMR/GCA , prednisolone is not part of the intervention.

DRUG

Placebo for hydrocortisone

Patients are randomised to either placebo or hydrocortisone supplemental doses in situations of stress. Patients will continue prednisolone treatment and tapering hereof according to current clinical guidelines for PMR/GCA , prednisolone is not part of the intervention.

Sponsors & Collaborators

  • Aarhus University Hospital

    collaborator OTHER

  • Odense University Hospital

    collaborator OTHER

  • Marianne Christina Klose

    lead OTHER

Principal Investigators

  • Ulla Feldt-Rasmussen, Professor · Rigshospitalet, Denmark

  • Marianne Klose, MD, PhD · Rigshospitalet, Denmark

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-07
Primary Completion
2026-06-30
Completion
2028-03-01

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05435781 on ClinicalTrials.gov