Hydrocortisone Vs Prednisolone in AI (HYPER-AID)

Adrenal Insufficiency Clinical Trial

— HYPER-AID  

Official title:

Hydrocortisone Versus Prednisolone for Treatment of Adrenal Insufficiency Disease (HYPER-AID Study)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03608943
• Other study ID #: 18HH4457
• Secondary ID: 234243
• Status: Recruiting
• Start date: May 24, 2018
• Est. completion date: December 31, 2025

Study information

• Verified date: November 2023
• Source: Imperial College London
• Contact: Sirazum Choudhury, MBBS MRCP
• Phone: 07555717544
• Email: steroids[@]imperial.ac.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study is designed to collect data on individuals with adrenal insufficiency who are changing treatments from hydrocortisone to prednisolone, or vice versa. It will compare anthropometric, biochemical and subjective health outcomes between both treatments.

Description:

In the UK, oral immediate release hydrocortisone divided in three doses daily has been the traditional treatment. The most common regimen in clinical practice uses doses of 10 mg on waking, 5 mg at lunch time and 5 mg in the afternoon. Once daily prednisolone is another regimen in clinical use and now prescribed at less than 5mg daily. It has a longer duration of action and a smoother pharmacokinetic profile compared to hydrocortisone. Moreover, prednisolone is much more cost-effective than hydrocortisone with 5mg tablets. Prednisolone is less commonly used due to perceived concerns regarding loss of bone mineral density leading to osteoporosis, increased insulin resistance leading to steroid induced diabetes, and rises in blood pressure and weight leading to increased cardiovascular risk. This belief is perhaps driven by the fact that most clinicians encounter prednisolone in the context of the treatment of asthma, rheumatoid arthritis etc. where far higher doses are employed. Where effects on bone health have been noted, they have been in association with higher doses of prednisolone (7.5mg) than those employed today (2-5mg). Although conventionally prednisolone 5 mg is assumed to be bioequivalent to HC 20 mg (ratio 1:4), newer studies suggest that the ratio may be nearer 1:6-8 i.e. lower doses can be used.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Adrenal Insufficiency

Intervention

Other:
• There is no specific intervention other than an individual changing their treatment as part of their usual care
There is no specific intervention other than an individual changing their treatment as part of their usual care

Locations

Country	Name	City	State
United Kingdom	Imperial College Healthcare NHS Trust	London

Sponsors (1)

Lead Sponsor	Collaborator
Imperial College London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	P1NP	measurement of bone turnover markers: P1NP,	Minimum 4 months of stable treatment
Primary	NTX	measurement of bone turnover markers: NTX	Minimum 4 months of stable treatment
Secondary	Heart rate	recording observations- heart rate	Minimum 4 months of stable treatment
Secondary	Blood pressure	recording observations- blood pressure	Minimum 4 months of stable treatment
Secondary	Waist-hip circumference	recording observations- waist-hip circumference ratios	Minimum 4 months of stable treatment
Secondary	Lipid profile (Total cholesterol, HDL, LDL and triglycerides)	measuring biochemical indicators of cardiovascular risk: total cholesterol, HDL, LDL and triglycerides	Minimum 4 months of stable treatment
Secondary	High sensitivity CRP	measuring biochemical indicators of cardiovascular risk: high sensitivity CRP	Minimum 4 months of stable treatment
Secondary	Glucose	assessed by measuring glucose	Minimum 4 months of stable treatment
Secondary	HbA1c	assessed by measuring HBA1c	Minimum 4 months of stable treatment
Secondary	Frequency and severity of steroid replacement related symptoms	assessed by reporting of symptoms of steroid deficiency, their frequency and severity stratified by the patient's current replacement regimen. Symptoms include nausea, lethargy, muscle pain, headaches etc.)	Minimum 4 months of stable treatment
Secondary	Efficacy of replacement and wellbeing	assessed using subjective health questionnaire	Minimum 4 months of stable treatment