Comparing hydrocortisone and prednisolone for adrenal insufficiency treatment
Hydrocortisone Versus Prednisolone for Treatment of Adrenal Insufficiency Disease (HYPER-AID Study)
This study is testing how switching between hydrocortisone and prednisolone affects people with adrenal insufficiency to see which treatment works better for their health.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Imperial College London Academic / other |
| Locations | 1 site (London) |
| Trial ID | NCT03608943 on ClinicalTrials.gov |
What this trial studies
This observational study aims to gather data on patients with adrenal insufficiency who are transitioning between hydrocortisone and prednisolone treatments. It will evaluate various health outcomes, including anthropometric and biochemical measures, as well as subjective health assessments. The study is particularly focused on understanding the effects of these glucocorticoids at lower doses, as prednisolone is often perceived to have more risks despite being more cost-effective. Participants will be monitored as they continue their usual care while switching medications.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 85 diagnosed with adrenal insufficiency for over six months and stable on their current glucocorticoid treatment.
Not a fit: Patients who are pregnant or unable to provide informed consent will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into safer and more effective treatment options for patients with adrenal insufficiency.
How similar studies have performed: While there is limited data on this specific comparison, other studies have explored glucocorticoid treatments, suggesting potential benefits of lower-dose prednisolone.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Aged 18 - 85 years * Male or female * Diagnosed with adrenal insufficiency (AI) for over 6 months according to standard diagnostic criteria * Established on stable hydrocortisone or prednisolone replacement, dose not altered for at least 4 months * Individuals taking other hormone replacements are accepted providing that their replacement doses have not altered for at least 3 months; * Individuals who are able and willing to give written informed consent to participate in the study Exclusion Criteria: * Individuals who are unable to give informed consent * Pregnancy (determined by patients self-reporting pregnancy status) * Patients using the combined oral contraceptive pill
Where this trial is running
London
- Imperial College Healthcare NHS Trust — London, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Karim Meeran, MBBS BSc MD — Imperial College London
- Study coordinator: Sirazum Choudhury, MBBS MRCP
- Email: steroids@imperial.ac.uk
- Phone: 07555717544
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.