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The Effects of Testosterone and Nutritional Supplementation in the Undernourished Elderly
The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2006 by University of Adelaide.
Recruitment status was: Active, not recruiting
Recruitment status was: Active, not recruiting
Sponsor:
University of Adelaide
Collaborator:
Organon
Information provided by:
University of Adelaide
ClinicalTrials.gov Identifier:
NCT00117000
First received: June 30, 2005
Last updated: September 7, 2006
Last verified: September 2006
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Purpose
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 community-dwelling older men and women.
| Condition | Intervention | Phase |
|---|---|---|
| Malnutrition Aging | Drug: testosterone undecanoate | Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Factorial Assignment Masking: Double-Blind 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 |
Resource links provided by NLM:
Further study details as provided by University of Adelaide:
Primary Outcome Measures:
- Days in hospital
- SF-36 quality of life scores (composite physical component score and composite mental component score).
Secondary Outcome Measures:
- Body composition
- Muscle strength
- Number of falls
- Functional status (living arrangements, activities of daily living and frailty scale scores)
- Mortality
| Estimated Enrollment: | 200 |
| Study Start Date: | July 2003 |
| Estimated Study Completion Date: | February 2007 |
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 hospitalizations, falls and weight loss in association with improvements in functional measures and increases in lean body mass. The present study is designed to examine the effect of 12 months oral nutrition supplementation and androgen therapy, alone and combined, on (i) frequency and length of hospitalisations; (ii) functional status; (iii) body composition and weight; (iv) living arrangements; (v) death rate, in community dwelling under-nourished men and women, 65 years and older.
Eligibility| Ages Eligible for Study: | 65 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00117000
Please refer to this study by its ClinicalTrials.gov identifier: NCT00117000
Locations
| Australia, South Australia | |
| Royal Adelaide Hospital | |
| Adelaide, South Australia, Australia, 5000 | |
Sponsors and Collaborators
University of Adelaide
Organon
Investigators
| Principal Investigator: | Ian M Chapman, MBBS, PhD | University of Adelaide |
More Information
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00117000 History of Changes |
| Other Study ID Numbers: |
030320 |
| Study First Received: | June 30, 2005 |
| Last Updated: | September 7, 2006 |
Keywords provided by University of Adelaide:
|
testosterone food, formulated malnutrition undernutrition |
aging aged aged, 80 and over frail elderly |
Additional relevant MeSH terms:
|
Malnutrition Nutrition Disorders Testosterone Testosterone enanthate Testosterone undecanoate Testosterone 17 beta-cypionate Methyltestosterone |
Androgens Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Antineoplastic Agents, Hormonal Antineoplastic Agents Anabolic Agents |
ClinicalTrials.gov processed this record on August 16, 2017