Hydrocortisone Vs Prednisolone in AI (HYPER-AID) (HYPER-AID)

  • STATUS
    Recruiting
  • End date
    Mar 20, 2023
  • participants needed
    100
  • sponsor
    Imperial College London
Updated on 5 March 2022
prednisolone
replacement therapy

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.

Details
Condition Adrenal Insufficiency
Treatment There is no specific intervention other than an individual changing their treatment as part of their usual care
Clinical Study IdentifierNCT03608943
SponsorImperial College London
Last Modified on5 March 2022

Eligibility

Yes No Not Sure

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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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