Condition category
Nutritional, Metabolic, Endocrine
Date applied
01/03/2005
Date assigned
10/06/2005
Last edited
02/07/2009
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

Dr Dafydd Aled Rees

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

SPON CU 086

Study information

Scientific title

Acronym

Study hypothesis

Patients with adrenal failure have impaired blood vessel function and that this can be improved by supplementing Dehydroepiandrosterone (DHEA).

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

Condition

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 names

Dehydroepiandrosterone (DHEA)

Primary outcome measures

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

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/05/2005

Overall trial end date

30/06/2006

Reason abandoned

Eligibility

Participant 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.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

40

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/05/2005

Recruitment end date

30/06/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Endocrinology
Cardiff
CF14 4XW
United Kingdom

Sponsor information

Organisation

Cardiff University (UK)

Sponsor details

Chris Shaw
Cardiff University
Research and Commercial division
30-36 Newport Road
Cardiff
CF23 0DE
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Not defined

Funder name

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

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

2009 results on http://www.ncbi.nlm.nih.gov/pubmed/19318448

Publication citations

  1. Results

    Rice SP, Agarwal N, Bolusani H, Newcombe R, Scanlon MF, Ludgate M, Rees DA, Effects of dehydroepiandrosterone replacement on vascular function in primary and secondary adrenal insufficiency: a randomized crossover trial., J. Clin. Endocrinol. Metab., 2009, 94, 6, 1966-1972, doi: 10.1210/jc.2008-2636.

Additional files

Editorial Notes