DHEA depletion in trauma and hip fracture patients. MedDRA version: 20.0 Level: PT Classification code 10056629 Term: Dehydroepiandrosterone decreased System Organ Class: 10022891 - Investigations
Conditions
Interventions
Product Name: Dehydroepiandrosterone filmcoat tablet
Pharmaceutical Form: Coated tablet
INN or Proposed INN: Dehydroepiandrosterone Oral Tablets
CAS Num
Sponsors
University Hospitals Birmingham
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The inclusion criteria is split into trauma patients and hip fracture patient cohorts. TRAUMA PATIENTS INCLUSION CRITERIA (males and females) - 16 - 50 years of age - Severely injured trauma patient (Injury severity score (ISS) =16 and =50) - Admitted to University Hospital Birmingham within 6 days of trauma - Anticipated to be an inpatient for the 11 day trial period HIP FRACTURE PATIENTS INCLUSION CRITERIA (females only) - 50 years of age and older. - Female. - Neck of Femur fracture. - Admitted to University Hospital Birmingham within 6 days of fracture. - Anticipated to be an inpatient for the 11 day trial period. Are the trial subjects under 18? yes Number of subjects for this age range: 10 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 200 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 60
Exclusion criteria
Exclusion criteria: The exclusion criteria is split into trauma patients and hip fracture patient cohorts. TRAUMA PATIENTS EXCLUSION CRITERIA 1. Ages 51 years of age. 2. ISS 50 3. Isolated brain injury. 4. Unlikely to survive the study period (11 days). 5. Previous or known hormone sensitive malignancy. 6. Known Prostatic hypertrophy (M) 7. Intake of adrenal medication prior to admission to hospital. 8. Female patients taking Hormone Replacement Therapy medication. 9. Intake of any drugs that is likely to influence the metabolism of steroids, in particular inducers and inhibitors of the drug-metabolising enzyme CYP3A4 in the last 3 months. 10. Previous documented liver failure. 11. Current malignancy with ongoing active treatment. 12. Prescribed antipsychotic medication. 13. Pregnant and/or breast-feeding females HIP FRACTURE PATIENTS EXCLUSION CRITERIA 1. <50 years of age. 2. Unlikely to survive the study period (11 days). 3. Previous or known hormone sensitive malignancy. 4. Intake of any drugs that is likely to influence the metabolism of steroids, in particular inducers and inhibitors of the drug-metabolising enzyme CYP3A4 in the last 3 months. 5. Previous documented liver failure. 6. Current malignancy with ongoing active treatment. 7. Prescribed antipsychotic medication. 8. Pregnant and/or breast-feeding females
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To establish a dose of supplemental Dehydroepiandrosterone (DHEA) sufficient to raise circulating DHEA levels in severely injured trauma and hip fracture patients, after up to 3 days of supplementation, to levels observed in healthy young male adults. ; Secondary Objective: To review the effect of a single and multiple dose of DHEA on circulating DHEA and DHEAS levels and related hormones. To assess if DHEA supplementation has any effect on neutrophil function, metabolic and cytokine profiles of severely injured trauma and female hip fracture patients. To identify what route of DHEA administration is more efficient at raising DHEA levels sufficiently. ; Primary end point(s): To establish a dose of supplemental Dehydroepiandrosterone (DHEA) sufficient to raise circulating DHEA levels in injured trauma and hip fracture patients, after 3 days of supplementation, to levels observed in healthy young male adults. ;Timepoint(s) of evaluation of this end point: Blood samples once daily on day 7,8,9,10,11. | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Blood samples once daily on day 7,8,9,10,11.; Secondary end point(s): To establish an optimal dose of DHEA to enhance immune function through the assessment of neutrophil function and cytokine profiles. To assess if DHEA supplementation via sublingual administration is more effective than an oral administration of the same dose. | — |
Countries
United Kingdom
Contacts
Public ContactLt Col Mark Foster
Queen Elizabeth Hospital, Birmingham
Outcome results
None listed