A Dehydroepiandrosterone and Pharmacokinetics in Trauma study (ADaPT)
Research type
Research Study
Full title
A prospective, phase II, single centre, cross-sectional, randomised trial investigating Dehydroepiandrosterone and its Pharmacokinetics in Trauma
IRAS ID
217834
Contact name
Lt. Col. Mark Foster
Contact email
Sponsor organisation
University Hospitals Birmingham
Eudract number
2016-004250-15
Duration of Study in the UK
1 years, 6 months, 1 days
Research summary
Hormones, such as Dehydroepiandrosterone (DHEA), play an important role in the body helping to maintain muscle mass and the immune system. The immune system helps the body recover from injury and fight off infection. Immediately after an injury DHEA levels have been shown to drop quickly and if DHEA levels are already low, as seen in older people, this puts them at increased risk of infection and reduces their chance of a full recovery. Our previous research has shown in both young and old men and women that DHEA levels are below normal levels for as long as 3 months after injury. As a result, we believe giving trauma patients DHEA to boost DHEA levels in the blood could improve the immune response and speed up recovery. The aim of this trial is to work out what dose of DHEA (50, 100 or 200mg per day) will increase patient’s DHEA levels to those seen in a healthy young adult males. We will also work out what is the best method of delivering the DHEA into the body either by an oral tablet that is swallowed or a tablet that is placed under the tongue and dissolves. A maximum of 270 patients will be recruited across three patient groups: male trauma, female trauma and elderly female hip fracture patients admitted to University Hospital Birmingham. These will be randomised to the route of delivery of the DHEA, either oral or sublingual tablet.
REC name
West Midlands - Coventry & Warwickshire Research Ethics Committee
REC reference
18/WM/0102
Date of REC Opinion
8 Jun 2018
REC opinion
Further Information Favourable Opinion