Safety and Efficacy of Prednisolone in Adrenal Insufficiency Disease (PRED-AID Study)

Launched by IMPERIAL COLLEGE LONDON · Apr 29, 2019

Keywords

ClinConnect Summary

The PRED-AID Study is a clinical trial that is investigating the safety and effectiveness of a medication called low-dose prednisolone for treating adrenal insufficiency (AI). AI is a condition where the body does not produce enough of a natural hormone called cortisol, which is important for managing stress and maintaining overall health. In this study, researchers are comparing the effects of low-dose prednisolone to the standard treatment, which is hydrocortisone, to see which works better for patients with this condition.

To participate in this study, individuals need to be between 18 and 70 years old and have been diagnosed with adrenal insufficiency for at least six months. They should also be stable on their current hormone replacement therapy for three months before joining the trial. Participants will be asked to provide their consent and will undergo a health check to ensure they are fit for the study. It’s important to note that certain conditions, like diabetes or pregnancy, may exclude someone from participating. This study is currently active but not recruiting new participants. If you or someone you know is interested, it’s best to discuss it with a healthcare provider for more information.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Aged 18 - 70 years
• • Male or female
• • Diagnosed with AI for over 6 months according to standard diagnostic criteria
• • Established on stable HC replacement or prednisolone replacement, dose not altered for at least 3 months
• • Established on a stable dose of Fludrocortisone, if taking, dose not altered for at least 3 months
• • Participants taking other hormone replacements (e.g. levothyroxine, testosterone or growth hormone in secondary adrenal insufficiency) are accepted providing that their replacement doses have not altered for at least 3 months
• • Participants who are otherwise healthy enough to participate, as determined by pre-study medical history and physical examination.
• • Participants who are able and willing to give written informed consent to participate in the study.
• Exclusion Criteria:
• • Participants with a diagnosis of Type 1 or Type 2 diabetes mellitus.
• • Unable to give informed consent.
• • Taking supplements or herbal medications that the participant is unwilling or unable to stop prior to and during the study period e.g. St John's Wort (may decrease prednisolone levels), Cat's claw, Echinacea (immunomodulatory properties).
• • Currently taking medications that alter CYP3A4 metabolism of glucocorticoids that the participant is unwilling or unable to stop prior to and during the study period e.g. phenytoin, phenobarbital, rifampicin, rifabutin, carbamazepine, primidone, aminoglutethimide, itraconazole, ketoconazole, ciclosporin or ritonavir.
• • Pregnancy, taking the combined oral contraceptive pill, or oral oestrogen replacement therapy due to the effects on cortisol binding globulin levels and determination of prednisolone levels. Transdermal oestrogen replacement is permitted.
• • Diagnosis of congenital adrenal hyperplasia, untreated