A randomised, double blind, placebo-controlled study of the effects of Dehydroepiandrosterone (DHEA) replacement on vascular function in patients with primary and secondary adrenal insufficiency

ISRCTN	ISRCTN46268487
DOI	https://doi.org/10.1186/ISRCTN46268487
Protocol serial number	SPON CU 086
Sponsor	Cardiff University (UK)
Funder	Funding is currently being sought from grant applications including the Cardiff and Vale NHS Small grants scheme and fellowship support from the Ipsen fund and the Royal College of Physicians

Submission date: 01/03/2005
Registration date: 10/06/2005
Last edited: 24/07/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Dafydd Aled Rees
Scientific

Department of Endocrinology
University Hospital of Wales
Heath Park
Cardiff
CF14 4XW
United Kingdom

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title	A randomised, double blind, placebo-controlled study of the effects of Dehydroepiandrosterone (DHEA) replacement on vascular function in patients with primary and secondary adrenal insufficiency
Study objectives	Patients with adrenal failure have impaired blood vessel function and that this can be improved by supplementing Dehydroepiandrosterone (DHEA).
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Primary and secondary adrenal insufficiency
Intervention	Interventions: DHEA replacement versus placebo Patients with primary and secondary adrenal insufficiency will be randomly allocated into tratment and placeco groups. An initial assessment will be made of blood vessel function (pulse wave analysis, pulse wave velocity and endothelial fuction). Participants will commence on either treatment or placebo for 12 weeks followed by futher blood vessel funtion assessment. There will then be a 6 week wash out period followed by a 3rd blood vessel assessment then a futher cross-over treatment/placebo phase in which those who received the placebo in the first 3 months will now be given the active treatment and those who initially had the active treatment will be given the placebo. After another 3 months the trial will finish with a final assessment of blood vessel function.
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Dehydroepiandrosterone (DHEA)
Primary outcome measure(s)	Pulse wave velocity Pulse wave analysis Endothelial function Blood tests for DHEA, high sensitivity C-reactive protein, plasminogen activator inhibitor-1, full lipid profile, testosterone, sex hormone binding globulin, oestradiol (males only), follicle stimulating hormone, luteinising hormone and liver function
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	09/01/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	40
Key inclusion criteria	Individuals with at least a 4 year history of primary adrenal insufficiency and those with secondary adrenal insufficiency as a result of pituitary surgery for a non-functioning pituitary tumour who did not receive radiotherapy and who are on stable doses of full hormone replacement including growth hormone.
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/05/2005
Date of final enrolment	30/06/2006

Locations

Countries of recruitment

United Kingdom
Wales

Study participating centre

Department of Endocrinology

Cardiff
CF14 4XW
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/06/2009		Yes	No

Editorial Notes

24/07/2019: The overall trial end date has been changed from 30/06/2006 to 09/01/2008.