Hydrocortisone Versus Methylprednisolone for the Treatment of Glucocorticoid-Induced Adrenal Insufficiency

ConditionAdrenal Insufficiency

Trial statusNot yet recruiting

Trial phasePhase 4

Trial typeInterventional

Biological sexAll

Age18+

SponsorUniversity Medical Centre Ljubljana

About this trial

This study aims to compare the use of methylprednisolone and hydrocortisone as replacement therapies in patients with glucocorticoid-induced adrenal insufficiency.

The primary goal is to evaluate and compare the recovery of the hypothalamic-pituitary-adrenal (HPA) axis.

Eligibility criteria

Qualifiers

Age over 18 years.

Suspected adrenal insufficiency due to receiving supraphysiological doses of methylprednisolone for more than 4 weeks.

Receiving methylprednisolone 4 mg for at least the last 4 weeks.

Morning cortisol lower than 300 nmol/L.

Disqualifiers

Known organic disease of the pituitary-adrenal axis.

Body mass over 130 kg.

Advanced comorbidities.

Advanced heart failure (NYHA IV).

Trial design

Treatments tested in this trial

Patients will receive 3 mg of methylprednisolone once daily. The dose is administered in the morning (1 ½ tablets of 2 mg Medrol after breakfast).
Patients will receive 15 mg of hydrocortisone daily. The dose is split into 10 mg in the morning after breakfast and 5 mg after 6-7 hours.

Treatment groups

66 Participants

are divided into 2 treatment groups

Sponsors and collaborators

University Medical Centre Ljubljana

Lead sponsor

University of Ljubljana

Collaborator

Source ClinicalTrials.gov