Adrenal InsufficiencyHYPER-AIDNCT03608943
Hydrocortisone Vs Prednisolone in AI (HYPER-AID)
An observational study of Adrenal Insufficiency, run by Imperial College London at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Adrenal Insufficiency
- How many people
- 100 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 24 May 2018to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Adult, Older adult
Study population: Individuals with either primary or secondary adrenal insufficiency who are currently receiving glucocorticoid replacement therapy with hydrocortisone or prednisolone.
Who may be able to join
- 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
Who cannot join
- Individuals who are unable to give informed consent
- Pregnancy (determined by patients self-reporting pregnancy status)
- Patients using the combined oral contraceptive pill
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Imperial College Healthcare NHS Trust
London, W12 8RF
Sirazum Choudhury, MBBS BSc, 07555717544, steroids@imperial.ac.uk
About this study
Official title: Hydrocortisone Versus Prednisolone for Treatment of Adrenal Insufficiency Disease (HYPER-AID Study)
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.
Read the detailed 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.
- Conditions
- Adrenal Insufficiency
- Being tested
- There is no specific intervention other than an individual changing their treatment as part of their usual care
- Keywords
- glucocorticoids, prednisolone, hydrocortisone
- Medical subject headings
- Adrenal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
There is no specific intervention other than an individual changing their treatment as part of their usual careOther
There is no specific intervention other than an individual changing their treatment as part of their usual care
| Study group | Role | What they receive |
|---|---|---|
| Adrenal insufficiency | Individuals who are in the process of changing their treatment from:
1. hydrocortisone to prednisolone or;
2. prednisolone to hydrocortisone Receives: Other: There is no specific intervention other than an individual changing their treatment as part of their usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
P1NP
measurement of bone turnover markers: P1NP,
Measured: Minimum 4 months of stable treatment
NTX
measurement of bone turnover markers: NTX
Measured: Minimum 4 months of stable treatment
Secondary outcomes (9)
Heart rate
recording observations- heart rate
Measured: Minimum 4 months of stable treatment
Blood pressure
recording observations- blood pressure
Measured: Minimum 4 months of stable treatment
Waist-hip circumference
recording observations- waist-hip circumference ratios
Measured: Minimum 4 months of stable treatment
Lipid profile (Total cholesterol, HDL, LDL and triglycerides)
measuring biochemical indicators of cardiovascular risk: total cholesterol, HDL, LDL and triglycerides
Measured: Minimum 4 months of stable treatment
High sensitivity CRP
measuring biochemical indicators of cardiovascular risk: high sensitivity CRP
Measured: Minimum 4 months of stable treatment
Glucose
assessed by measuring glucose
Measured: Minimum 4 months of stable treatment
HbA1c
assessed by measuring HBA1c
Measured: Minimum 4 months of stable treatment
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.)
Measured: Minimum 4 months of stable treatment
Efficacy of replacement and wellbeing
assessed using subjective health questionnaire
Measured: Minimum 4 months of stable treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2018
- Study start24 May 2018
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adrenal InsufficiencyStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Karim Meeran, MBBS BSc MD, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03608943
- Sponsor's protocol ID
- 18HH4457
- Other IDs
- 234243
- Acronym
- HYPER-AID
- Status last verified
- Nov 2023
- First submitted
- 18 Jun 2018
- Last updated
- 29 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There are currently no plans to share individual data with other researchers
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hydrocortisone Versus Prednisolone for Treatment of Adrenal Insufficiency Disease (HYPER-AID Study)
- ClinicalTrials.gov ID
- NCT03608943
- Acronym / sponsor ID
- HYPER-AID / 18HH4457
- Conditions
- Adrenal Insufficiency
- Keywords
- glucocorticoids, prednisolone, hydrocortisone
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- 24 May 2018 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 1 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Case crossover
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adrenal insufficiency | – | Other: There is no specific intervention other than an individual changing their treatment as part of their usual careIndividuals who are in the process of changing their treatment from: 1. hydrocortisone to prednisolone or; 2. prednisolone to hydrocortisone |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Individuals with either primary or secondary adrenal insufficiency who are currently receiving glucocorticoid replacement therapy with hydrocortisone or prednisolone.
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (3 listed)
- Individuals who are unable to give informed consent
- Pregnancy (determined by patients self-reporting pregnancy status)
- Patients using the combined oral contraceptive pill
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| There is no specific intervention other than an individual changing their treatment as part of their usual careThere is no specific intervention other than an individual changing their treatment as part of their usual care | Other | Adrenal insufficiency |
Primary outcome
P1NP
Time frame: Minimum 4 months of stable treatment
measurement of bone turnover markers: P1NP,
NTX
Time frame: Minimum 4 months of stable treatment
measurement of bone turnover markers: NTX
9 secondary outcomes
Heart rate
Time frame: Minimum 4 months of stable treatment
Blood pressure
Time frame: Minimum 4 months of stable treatment
Waist-hip circumference
Time frame: Minimum 4 months of stable treatment
Lipid profile (Total cholesterol, HDL, LDL and triglycerides)
Time frame: Minimum 4 months of stable treatment
High sensitivity CRP
Time frame: Minimum 4 months of stable treatment
Glucose
Time frame: Minimum 4 months of stable treatment
HbA1c
Time frame: Minimum 4 months of stable treatment
Frequency and severity of steroid replacement related symptoms
Time frame: Minimum 4 months of stable treatment
Efficacy of replacement and wellbeing
Time frame: Minimum 4 months of stable treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2023.
- Individual participant dataSharing planned: No. There are currently no plans to share individual data with other researchers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karim Meeran, MBBS BSc MD principal investigator
Imperial College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adrenal Insufficiency, run by Imperial College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sirazum Choudhury, MBBS MRCP (07555717544, steroids@imperial.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
P1NP (time frame: Minimum 4 months of stable treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2023.