Adrenocortical carcinoma · ISRCTN41325341
PRED-AID: Prednisolone in adrenal insufficiency disease
Safety and efficacy of Prednisolone in Adrenal Insufficiency Disease (PRED-AID study)
- Status
- recruitment ended 2023-02-01 (ISRCTN)
- Phase
- Phase III
- Sponsor
- Not stated
- Registry records
- ISRCTN ISRCTN41325341 (recruitment ended 2023-02-01)Registry last updated 2025-02-11
Eligibility, line by line
Inclusion criteria: 1. Aged 18 – 70 years 2. Male or female 3. Diagnosed with AI for over 6 months according to standard diagnostic criteria 4. Established on stable HC replacement or prednisolone replacement, dose not altered for at least 3 months 5. Established on a stable dose of Fludrocortisone, if taking, dose not altered for at least 3 months 6. 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 7. Participants who are otherwise healthy enough to participate, as determined by pre-study medical history and physical examination 8. Participants who are able and willing to give written informed consent to participate in the study Exclusion criteria: 1. Participants with a diagnosis of Type 1 or Type 2 diabetes mellitus 2. Unable to give informed consent 3. 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) 4. 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, aminogluethimide, itraconazole, ketoconazole, ciclosporin or ritonavir 5. Pregnancy, taking the 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 6. Diagnosis of congenital adrenal hyperplasia, untreated
Full eligibility text as the registry publishes it
Inclusion criteria: 1. Aged 18 – 70 years 2. Male or female 3. Diagnosed with AI for over 6 months according to standard diagnostic criteria 4. Established on stable HC replacement or prednisolone replacement, dose not altered for at least 3 months 5. Established on a stable dose of Fludrocortisone, if taking, dose not altered for at least 3 months 6. 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 7. Participants who are otherwise healthy enough to participate, as determined by pre-study medical history and physical examination 8. Participants who are able and willing to give written informed consent to participate in the study Exclusion criteria: 1. Participants with a diagnosis of Type 1 or Type 2 diabetes mellitus 2. Unable to give informed consent 3. 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) 4. 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, aminogluethimide, itraconazole, ketoconazole, ciclosporin or ritonavir 5. Pregnancy, taking the 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 6. Diagnosis of congenital adrenal hyperplasia, untreated
Routes in: how this trial is reached and paid for
UK access: residence, not citizenship
Being a British citizen does not by itself entitle you to free NHS treatment; entitlement runs on being ordinarily resident in the UK.
The UK and EU agreed to continue a planned-treatment scheme equivalent to S2 from 1 January 2021, so an S2 issued by an EU insurer is the thing to ask about for a UK trial. Put the question to both your insurer and the trial coordinator, since sponsors sometimes cover trial-related care regardless.
Verify with: NHS: planned treatment abroad and the S2 route
Ask both; not free by citizenship
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Sites (1)
United Kingdom
- Imperial College Healthcare NHS Trust, London