The Effects of Testosterone and Nutritional Supplementation in the Undernourished Elderly
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ClinicalTrials.gov Identifier: NCT00117000 |
Recruitment Status : Unknown
Verified September 2006 by University of Adelaide.
Recruitment status was: Active, not recruiting
First Posted : July 1, 2005
Last Update Posted : September 11, 2006
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Malnutrition Aging | Drug: testosterone undecanoate | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 200 participants |
Allocation: | Randomized |
Intervention Model: | Factorial Assignment |
Masking: | Double |
Primary Purpose: | Treatment |
Official Title: | The Effects of Testosterone and Nutritional Supplementation, Alone and Combined, on the Adverse Effects of Under-Nutrition in the Elderly |
Study Start Date : | July 2003 |
Study Completion Date : | February 2007 |

- Days in hospital
- SF-36 quality of life scores (composite physical component score and composite mental component score).
- Body composition
- Muscle strength
- Number of falls
- Functional status (living arrangements, activities of daily living and frailty scale scores)
- Mortality

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Ages Eligible for Study: | 65 Years and older (Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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 Criteria:
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00117000
Australia, South Australia | |
Royal Adelaide Hospital | |
Adelaide, South Australia, Australia, 5000 |
Principal Investigator: | Ian M Chapman, MBBS, PhD | University of Adelaide |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: | NCT00117000 |
Other Study ID Numbers: |
030320 |
First Posted: | July 1, 2005 Key Record Dates |
Last Update Posted: | September 11, 2006 |
Last Verified: | September 2006 |
testosterone food, formulated malnutrition undernutrition |
aging aged aged, 80 and over frail elderly |
Malnutrition Nutrition Disorders Methyltestosterone Testosterone Testosterone undecanoate Testosterone enanthate Testosterone 17 beta-cypionate |
Androgens Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Antineoplastic Agents, Hormonal Antineoplastic Agents Anabolic Agents |