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Hydrocortisone Vs Prednisolone in AI (HYPER-AID)

NCT ID: NCT03608943

Last Updated: 2023-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-05-24

Study Completion Date

2025-12-31

Brief Summary

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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

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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

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Adrenal Insufficiency

Study Design

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Observational Model Type

CASE_CROSSOVER

Study Time Perspective

RETROSPECTIVE

Study Groups

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Adrenal insufficiency

Individuals who are in the process of changing their treatment from:

1. hydrocortisone to prednisolone or;
2. prednisolone to hydrocortisone

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

Intervention Type OTHER

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

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Imperial College London

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Karim Meeran, MBBS BSc MD

Role: PRINCIPAL_INVESTIGATOR

Imperial College London

Locations

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Imperial College Healthcare NHS Trust

London, , United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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Sirazum Choudhury, MBBS MRCP

Role: CONTACT

[email protected]
07555717544

Facility Contacts

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Sirazum Choudhury, MBBS BSc

Role: primary

[email protected]
07555717544

Other Identifiers

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234243

Identifier Type: OTHER

Identifier Source: secondary_id

18HH4457

Identifier Type: -

Identifier Source: org_study_id