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ISRCTN
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ISRCTN18758725
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ClinicalTrials.gov identifier
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Public title
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Immune effects of dehydroepiandrosterone (DHEA) in adrenal insufficiency (IDHEAL)
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Scientific title
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Acronym
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N/A
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Serial number at source
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N0265126494
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Study hypothesis
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The central hypothesis to be tested is that the pathologic DHEA deficiency that invariably accompanies adrenal insufficiency is the primary factor responsible for previously observed impairment of immune function in these patients. Arising from this hypothesis the study aims to answer two questions:
1. Will immune function in patients with adrenal insufficiency show beneficial changes following DHEA replacement therapy?
2. Will DHEA replacement therapy alter endocrine-immune interactions as exemplified by steroidogenesis in immune cells?
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Nutritional, Metabolic, Endocrine: Adrenal insufficiency
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Participants - inclusion criteria
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25 patients with primary adrenal insufficiency and 25 patients with hypopituitarism including secondary adrenal insufficiency will be recruited from the Endocrine Clinics at the Queen Elizabeth Hospital and at the Selly Oak hospital. Patients will be on stable hormone replacement therapy including glucocorticoids and will have confirmed serum DHEAS levels below the lower limit of the sex-specific reference range. Age will be between 18 and 50 years.
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Participants - exclusion criteria
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Not provided at time of registration
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Anticipated start date
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17/07/2003
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Anticipated end date
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17/07/2008
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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50
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Interventions
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25 patients with Addison's disease and 25 patients with hypopituitarism including secondary adrenal insufficiency will receive daily treatment with either 50 mg of DHEA or placebo orally for 16 weeks. At baseline and at the end of the treatment period patients will provide blood samples for analysis of T cell and neutrophil function, serum steroid hormones and steroid conversion in peripheral blood mononuclear cells. During the course of the study patients will undergo routine safety checks including clinical assessment and measurement of steroid hormone levels in monthly to bimonthly intervals.
The procedures described will be done for research purposes and are not normal clinical practice.
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Primary outcome measure(s)
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Not provided at time of registration
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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University Hospital Birmingham NHS Trust (UK)
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Trial website
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Publications
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Contact name
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Prof
P M
Stewart
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Address
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Endocrinology
University of Birmingham
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City/town
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Birmingham
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Zip/Postcode
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B15 2TT
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Country
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United Kingdom
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Sponsor
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Record Provided by the NHSTCT Register - 2004 Update - Department of Health (UK)
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Address
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The Department of Health,
Richmond House,
79 Whitehall
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City/town
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London
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Zip/Postcode
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SW1A 2NL
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Country
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United Kingdom
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Tel
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+44 (0)20 7307 2622
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Email
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dhmail@doh.gsi.org.uk
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Sponsor website:
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http://www.dh.gov.uk/Home/fs/en
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Date applied
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30/09/2004
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Last edited
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08/05/2008
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Date ISRCTN assigned
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30/09/2004
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