Safety and Efficacy of Prednisolone in Adrenal Insufficiency Disease (PRED-AID Study)
NCT03936517 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 44
Last updated 2023-09-01
Summary
This study compares low-dose prednisolone therapy against standard regimens of hydrocortisone therapy for the treatment of adrenal insufficiency (AI). AI is a condition in which, individuals are unable to sufficiently produce the natural stress hormone, cortisol.
Conditions
Interventions
- DRUG
-
Prednisolone
Low dose prednisolone for the treatment of adrenal insufficiency. Usually administered once daily
- DRUG
-
Hydrocortisone
Standard regimens of hydrocortisone for the treatment of adrenal insufficiency. Usually administered thrice daily.
Sponsors & Collaborators
-
National Institute for Health Research, United Kingdom
collaborator OTHER_GOV -
Imperial Health Charity
collaborator OTHER -
Imperial College London
lead OTHER
Principal Investigators
-
Karim Meeran, MBBS BSc MD · Imperial College London
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-07-31
- Primary Completion
- 2025-02-01
- Completion
- 2025-02-01
Countries
- United Kingdom
Study Locations
More Related Trials
-
Hydrocortisone and Placebo in Patients With Symptoms of Adrenal Insufficiency After Cessation of Glucocorticoid Treatment
NCT05193396 ·Status: RECRUITING ·Phase: PHASE4
-
Congenital Adrenal Hyperplasia Once Daily Hydrocortisone Treatment
NCT03760835 ·Status: RECRUITING ·Phase: PHASE4
-
Ramadan Fasting in Patients With Corticotrope Deficiency Treated Either by Hydrocortisone or by Prednisolone
NCT03585829 ·Status: COMPLETED ·Phase: PHASE4
-
Glucocorticoid Treatment in Addison's Disease
NCT01063569 ·Status: COMPLETED ·Phase: PHASE2/PHASE3
-
Post-corticosteroid Insufficiency: Search for a Threshold Value for Cortisol at 8 Hours, Prospective Study
NCT06208098 ·Status: NOT_YET_RECRUITING ·Phase: NA
-
The Hypothalamic-Pituitary-Adrenal (HPA) Axis as an Effector System in Weight Regulation
NCT00688987 ·Status: COMPLETED ·Phase: NA
-
Comparison of Chronocort Versus Standard Hydrocortisone Replacement Therapy in Participants Aged 16 Years and Over With Congenital Adrenal Hyperplasia
NCT05063994 ·Status: COMPLETED ·Phase: PHASE3
-
A Block-and-Replace Therapy With Osilodrostat and Concomitant Glucocorticoid Replacement
NCT06430528 ·Status: RECRUITING
-
Dual RElease Hydrocortisone Versus conventionAl Glucocorticoid replaceMent Therapy in Hypocortisolism (DREAM)
NCT02277587 ·Status: COMPLETED ·Phase: PHASE4
-
Effect of Supplemental Hydrocortisone During Stress in Prednisolone-induced Adrenal Insufficiency
NCT05435781 ·Status: RECRUITING ·Phase: PHASE4
-
The Effects of Two Brands of Hydrocortisone Injected Intramuscularly Into Deltoid and Thigh Muscles
NCT05350020 ·Status: UNKNOWN ·Phase: PHASE4
-
The Influence of Different Hydrocortisone Replacement Doses on the Partitioning and Flexibility of Ectopic Lipids in Patients With Corticotropic Hypopituitarism
NCT02360046 ·Status: TERMINATED ·Phase: NA
-
Does Relative Hypoglycaemia &/or Sleep Disturbance Contribute to the Lethargy Observed in Addison's Disease
NCT05515055 ·Status: UNKNOWN
-
Updated Diagnostic Cortisol Values for Adrenal Insufficiency
NCT05149638 ·Status: RECRUITING ·Phase: NA
-
Self-management in Patients With Adrenal Insufficiency.
NCT06637722 ·Status: ACTIVE_NOT_RECRUITING
-
Study to Evaluate CORT125134 in Participants With Cushing's Syndrome
NCT02804750 ·Status: COMPLETED ·Phase: PHASE2
-
Hydrocortisone in Hormone Replacement Therapy for Large Pituitary Neuroendocrine Tumors
NCT06679816 ·Status: RECRUITING ·Phase: PHASE4
-
Comparison of Two Forms of Hydrocortisone in Patients With Congenital Adrenal Hyperplasia
NCT00519818 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Metabolic Effects of Acute Cortisol Withdrawal in Adrenal Failure
NCT00442390 ·Status: COMPLETED ·Phase: NA
-
Pharmacokinetics of Hydrocortisone After Subcutaneous Administration in Chronic Adrenal Insufficiency
NCT01450930 ·Status: COMPLETED ·Phase: PHASE2
-
Mass Spectrometry Based Cutoffs for Cortisol After Stimulation Tests
NCT02818660 ·Status: COMPLETED ·Phase: NA
-
Hydrocortisone Use During Peri-operation for Pituitary Adenomas
NCT04621565 ·Status: UNKNOWN ·Phase: NA
-
Glucocorticoids in Patients With IgG4-RD
NCT01758393 ·Status: UNKNOWN ·Phase: PHASE2/PHASE3
-
Effect of Vorinostat on ACTH Producing Pituitary Adenomas in Cushing s Disease
NCT04339751 ·Status: WITHDRAWN ·Phase: PHASE2
-
An Efficacy and Safety Trial of Intravenous Zoledronic Acid Twice Yearly in Osteoporotic Children Treated With Glucocorticoids
NCT00799266 ·Status: COMPLETED ·Phase: PHASE3