Immune effects of dehydroepiandrosterone (DHEA) in adrenal insufficiency (IDHEAL)

ISRCTN ISRCTN18758725
DOI https://doi.org/10.1186/ISRCTN18758725
Protocol serial number N0265126494
Sponsor Department of Health
Funder University Hospital Birmingham NHS Trust (UK)
Submission date
30/09/2004
Registration date
30/09/2004
Last edited
17/08/2015
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof P M Stewart
Scientific

Endocrinology
University of Birmingham
Birmingham
B15 2TT
United Kingdom

Study information

Primary study designInterventional
Study designRandomised controlled trial
Secondary study designRandomised controlled trial
Study type Participant information sheet
Scientific titleImmune effects of dehydroepiandrosterone (DHEA) in adrenal insufficiency (IDHEAL)
Study objectivesThe 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(s)Not provided at time of registration
Health condition(s) or problem(s) studiedNutritional, Metabolic, Endocrine: Adrenal insufficiency
Intervention25 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 typeDrug
PhaseNot Applicable
Drug / device / biological / vaccine name(s)Dehydroepiandrosterone (DHEA)
Primary outcome measure(s)

Not provided at time of registration

Key secondary outcome measure(s)

Not provided at time of registration

Completion date17/07/2008

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexAll
Target sample size at registration50
Key inclusion criteria25 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.
Key exclusion criteriaNot provided at time of registration
Date of first enrolment17/07/2003
Date of final enrolment17/07/2008

Locations

Countries of recruitment

  • United Kingdom
  • England

Study participating centre

University of Birmingham
Birmingham
B15 2TT
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Participant information sheet Participant information sheet 11/11/2025 11/11/2025 No Yes
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