Clinical trial: Safety and Efficacy of Prednisolone in Adrenal Insufficiency Disease (PRED-AID Study) (NCT03936517)

Eligibility criteria:
Inclusion Criteria:

          -  Aged 18 - 70 years

          -  Male or female

          -  Diagnosed with AI for over 6 months according to standard diagnostic criteria

          -  Established on stable HC replacement or prednisolone replacement, dose not altered for
             at least 3 months

          -  Established on a stable dose of Fludrocortisone, if taking, dose not altered for at
             least 3 months

          -  Participants taking other hormone replacements (e.g. levothyroxine, testosterone or
             growth hormone in secondary adrenal insufficiency) are accepted providing that their
             replacement doses have not altered for at least 3 months

          -  Participants who are otherwise healthy enough to participate, as determined by
             pre-study medical history and physical examination.

          -  Participants who are able and willing to give written informed consent to participate
             in the study.

        Exclusion Criteria:

          -  Participants with a diagnosis of Type 1 or Type 2 diabetes mellitus.

          -  Unable to give informed consent.

          -  Taking supplements or herbal medications that the participant is unwilling or unable
             to stop prior to and during the study period e.g. St John's Wort (may decrease
             prednisolone levels), Cat's claw, Echinacea (immunomodulatory properties).

          -  Currently taking medications that alter CYP3A4 metabolism of glucocorticoids that the
             participant is unwilling or unable to stop prior to and during the study period e.g.
             phenytoin, phenobarbital, rifampicin, rifabutin, carbamazepine, primidone,
             aminoglutethimide, itraconazole, ketoconazole, ciclosporin or ritonavir.

          -  Pregnancy, taking the combined oral contraceptive pill, or oral oestrogen replacement
             therapy due to the effects on cortisol binding globulin levels and determination of
             prednisolone levels. Transdermal oestrogen replacement is permitted.

          -  Diagnosis of congenital adrenal hyperplasia, untreated
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 70 Years

Patient description (medical language): A 33-year-old woman comes to clinic complaining of progressive fatigue, decreased appetite, and 11-lb weight loss in the past 2 months.  She uses levothyroxine because of the previously diagnosed Hashimoto disease. She has no other medical conditions and does not use tobacco, alcohol, or illicit drugs.  Physical examination shows a generalized increase in pigmentation of the skin.  Measurement of serum cortisol before and after administration of exogenous adrenocorticotropic hormone (ACTH) shows no difference in the levels. Stable glucocorticoid replacement therapy starts for her with the diagnosis for primary adrenal insufficiency (Addison disease)

Patient description (patient's own words): I went to the clinic because I was really suffering from fatigue and decreased appetite and I also lost 11 pounds over the past two months. I'm just 33 years old so that's not normal, especially for a woman. I take levothyroxine because I have been diagnosed with Hashimoto disease. I don't have any other medical condition, and I don't smoke I don't drink, and I don't do drugs. They also did my physical examination and they saw that I had an increase in pigmentation of my skin. They measured my cortisol level before and after giving me some ACTH hormone, and the results came back with no difference whatsoever. The doctor told me I have Addison disease and put me under glucocorticoid therapy.

Does the patient match the trial criteria? 0