Condition category
Nutritional, Metabolic, Endocrine
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
17/08/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof P M Stewart

ORCID ID

Contact details

Endocrinology
University of Birmingham
Birmingham
B15 2TT
United Kingdom

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

http://www.dh.gov.uk/Home/fs/en

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

Publication citations

Additional files

Editorial Notes