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

No results posted yet for this study

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

Entities

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 NCT03936517 on ClinicalTrials.gov