Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0265126494
Study information
Scientific title
Immune effects of dehydroepiandrosterone (DHEA) in adrenal insufficiency (IDHEAL)
Acronym
Study hypothesis
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?
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Nutritional, Metabolic, Endocrine: Adrenal insufficiency
Intervention
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.
Intervention type
Drug
Phase
Not Applicable
Drug names
Dehydroepiandrosterone (DHEA)
Primary outcome measures
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
17/07/2003
Overall trial end date
17/07/2008
Reason abandoned
Eligibility
Participant inclusion criteria
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.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
50
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
17/07/2003
Recruitment end date
17/07/2008
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University of Birmingham
Birmingham
B15 2TT
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
University Hospital Birmingham NHS Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary