Immune effects of dehydroepiandrosterone (DHEA) in adrenal insufficiency (IDHEAL)
| ISRCTN | ISRCTN18758725 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN18758725 |
| Secondary identifying numbers | N0265126494 |
- 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
Scientific
Endocrinology
University of Birmingham
Birmingham
B15 2TT
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Immune effects of dehydroepiandrosterone (DHEA) in adrenal insufficiency (IDHEAL) |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Dehydroepiandrosterone (DHEA) |
| Primary outcome measure | Not provided at time of registration |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 17/07/2003 |
| Completion date | 17/07/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 50 |
| Key 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. |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 17/07/2003 |
| Date of final enrolment | 17/07/2008 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
University of Birmingham
Birmingham
B15 2TT
United Kingdom
B15 2TT
United Kingdom
Sponsor information
Department of Health
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.dh.gov.uk/Home/fs/en |
|---|
Funders
Funder type
Government
University Hospital Birmingham NHS Trust (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
