Status:
COMPLETED
Biological Effects of Dehydroepiandrosterone (DHEA) in the Elderly
Lead Sponsor:
National Institute on Aging (NIA)
Conditions:
Healthy
Eligibility:
All Genders
60+ years
Phase:
NA
Brief Summary
The purpose of the study is to examine whether DHEA replacement therapy is associated with beneficial changes in body composition (i.e., increases in lean mass and bone mass, and decreases in fat mass...
Detailed Description
The central hypothesis of this study is that restoring circulating levels of the adrenal hormone dehydroepiandrosterone (DHEA) in older people with low levels to more youthful levels will be associate...
Eligibility Criteria
Inclusion
- Healthy women and men
- Age 60 or older
- Age-appropriate DHEAS levels, but 70% lower than normal DHEAS levels for a 25-year old
Exclusion
- Contraindications to DHEA treatment (personal history of breast cancer or other estrogen-dependent neoplasms, acute liver disease, undiagnosed vaginal bleeding in women, history or evidence of prostate cancer or benign prostatic hyperplasia (BPH) in men)
- Angina
- Resting blood pressure over 180/95
- Chronic infections
- Hypothyroidism
- Depression
- Hormone therapy within the previous 6 months
- Insulin-dependent or poorly controlled diabetes
- Serum DHEAS level greater than 140 micrograms per deciliter (µg/dL)
- Prohibited Medications:
- Hormone therapy other than stable regimen of thyroid replacement
- Oral glucocorticoids
- Insulin
Key Trial Info
Start Date :
August 1 2000
Trial Type :
INTERVENTIONAL
End Date :
March 1 2005
Estimated Enrollment :
144 Patients enrolled
Trial Details
Trial ID
NCT00111930
Start Date
August 1 2000
End Date
March 1 2005
Last Update
December 11 2009
Active Locations (1)
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1
University of Colorado at Denver and Health Sciences Center
Denver, Colorado, United States, 80262