Status:
UNKNOWN
The Effects of Testosterone and Nutritional Supplementation in the Undernourished Elderly
Lead Sponsor:
University of Adelaide
Collaborating Sponsors:
Organon
Conditions:
Malnutrition
Aging
Eligibility:
All Genders
65+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to determine what effect treatment for one year with testosterone and a nutritional supplement, alone and combined, has on the adverse effects of under-nutrition in commun...
Detailed Description
We hypothesize that oral androgen therapy and nutritional supplementation will have additive beneficial effects in older malnourished individuals living in the community; there will be a reduction in ...
Eligibility Criteria
Inclusion
- Men and women aged 65 years or older who are under-nourished, as defined by a Mini Nutritional Assessment (MNA) score \<24 AND 1 or more of the following: \*a body mass index (BMI) of less than 22 kg/m2; \*weight loss of \> 7.5% in the 3 months before enrolling in the study
- Living independently in the community (not in a hospital, nursing home or hostel)
- Understand and sign informed consent document, able to communicate with the investigator, and understand and comply with the requirements of the study.
- Women who are taking oestrogen or other hormone replacement therapy (HRT) may take part (see exclusion criteria for exceptions), as may women who are not taking HRT. If a woman is taking HRT she must have been on a stable dose for at least 3 months before enrolment in the study. If not on HRT, she must not have been taking it for at least 3 months before enrolment.
Exclusion
- Dementia as indicated by a Folstein's Mini Mental State Examination (MMSE) score of \< 23
- Elevated haematocrit (HCT) levels (\>50%)
- Past or present history of prostatic cancer in men (Prostate Specific Antigen (PSA) levels \[\> age-related normal range and/or irregular prostate on prostate examination\]) or breast cancer.
- Pre-existing androgenic signs or symptoms in women of concern to either subject or investigator (deep voice, hirsutism, acne, androgenic hair loss).
- Depression (Yesavage Geriatric Depression Scale (GDS) Score \> 11)
- Inability to attend DEXA scan or complete other requirements of the study
- Significant cardiac failure (NYHA Class III and above)
- Significantly abnormal liver function tests (ALT, GGT, bilirubin or ALP more than 2 times the upper limit of normal)
- Nephrotic syndrome; 24h urine protein excretion \> 3 grams (if baseline urinalysis reveals \> 1+ proteinuria, quantification will be performed) AND/OR calculated creatinine clearance (by the equation of Baracskay and Jarjoura for ambulatory elderly subjects \[Cr clearance = 4.4/serum creatinine (mmol/L) + (88-age)\](63) \< 30 ml/min) AND/OR serum creatinine concentration \> 0.2mmol/l.
- Amputee (body mass index, creatinine clearance and body composition estimations inaccurate).
- Any disease, which in the opinion of the investigator is likely to lead to death within one year
- Testosterone or other androgen therapy (including DHEA and tibolone) in the four months before starting the study.
- Medication with cyclosporin or barbiturates
Key Trial Info
Start Date :
July 1 2003
Trial Type :
INTERVENTIONAL
End Date :
February 1 2007
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00117000
Start Date
July 1 2003
End Date
February 1 2007
Last Update
September 11 2006
Active Locations (1)
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1
Royal Adelaide Hospital
Adelaide, South Australia, Australia, 5000