Trial from ANZCTR


Trial ID ACTRN12610000356066
Trial Status: Registered
Date Submitted: 26/04/2010
Date Registered: 4/05/2010
Retrospectively registered

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Public title The effect of testosterone and a nutritional supplement on hospital admissions in under-nourished, older people.
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Study title in 'Participant- Intervention- Comparator- Outcome (PICO)' format The effect of testosterone and a nutritional supplement on hospital admissions in under-nourished, older people.
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Secondary ID [1] 251667 0
Nil
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UTN
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Trial acronym
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Health condition(s) or problem(s) studied:
Acute Hospitalization 257008 0
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Quality of Life Years 257015 0
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Body Composition 257018 0
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Frailty Score 257019 0
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Nutrition Score 257020 0
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Strength in under-nourished, older people. 257021 0
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Condition category: Condition code:
Diet and nutrition Obesity
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Metabolic and Endocrine Normal metabolism and endocrine development and function
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257413 257413 0 0

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Descriptions of intervention(s) / exposure Nutritional liquid supplement 2 times per day (180 ml) for 12 months,
and oral capsule andriol testocaps (testosterone undecanoate) (40mg daily women, 80mg twice daily men) for 12 months.

The vanilla nutritional supplement delivers 70.97kJ/180 mls, 0.186g protein, 0.98 g fat and 35-45 g carbohydrate.
The chocolate nutritutional supplement delivers 95.48 kJ/180 mls, 0.186 g protein, and 0.98 g of fat.
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Treatment: drugs 256192 0
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Comparator / control treatment Placebo oral capsule contains microcrystalline cellulose only.
(40mg daily women, 80mg twice daily men) for 12 months.

Placebo liquid supplement 2 times per day (180 ml) for 12 months.

The Nutritional placebo supplement has the following caloric content:
Chocolate 180 ml, energy 95.48 kj, fat 0.98 gm, protein 0.186 gm,
Vanilla 180 ml, energy 70.97 kj, fat 0.98 gm, protein 0.186 gm
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Control group Placebo
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Primary Outcome: Days in hospital and number of hospital admissions assessed by telephone contact with participant. 258066 0
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Timepoint: 12 months following randomisation. 258066 0
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Primary Outcome: Quality-adjusted Life Years (QALYS).
The (QALY) is a measure of disease burden, including both the quality and the quantity of life lived. It is used in assessing the value for money of a medical intervention. The QALY model requires utility independent, risk neutral, and constant proportional tradeoff behaviour. The QALY is based on the number of years of life that would be added by the intervention. Each year in perfect health is assigned the value of 1.0 down to a value of 0.0 for death.
258067 0
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Timepoint: 12 months following randomisation 258067 0
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Secondary Outcome: Nutritional Health assessed by questionnaires and blood tests. 263646 0
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Timepoint: 3, 6 and 12 months following randomisation. 263646 0
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Secondary Outcome: Walk time assessed by physical activity cut-off time to walk 15 feet (based on the short version of the Minnesota Leisure Time Activity Questionnaire). 263652 0
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Timepoint: Baseline, 6 and 12 months following randomisation. 263652 0
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Secondary Outcome: Frailty Score assessed by questionnaire Fried?s Frailty Scale. 263653 0
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Timepoint: Baseline, 6 and 12 months following randomisation. 263653 0
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Secondary Outcome: Grip Strength assessed by hand grip dynamometer test 263654 0
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Timepoint: Baseline, 6 and 12 months following randomisation. 263654 0
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Secondary Outcome: Fat Free Mass assessed by Bioelectrical Impedance analysis (BIA). 263655 0
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Timepoint: Baseline and 12 months following randomisation. 263655 0
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Key inclusion criteria 1.Men and women aged 65 years or older who are under-nourished, as defined by
Mini Nutritional Assessment (MNA) score 17-23.5 out of 30.
AND 1 or more of
A body mass index (BMI) of less than 22 kg/m2
Weight loss in the 3 months before enrolling in the study
2.Living independently in the community (not in a hospital, nursing home or hostel)
3.Understand and sign the informed consent document, able to communicate with the investigator, and understand and comply with the requirements of the study.
4.Women who are taking oestrogen or other hormone replacement therapy (HRT) may take part, 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.
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Minimum age 65 Years
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Maximum age No limit
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Gender Both males and females
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Healthy volunteers? No
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Key exclusion criteria 1.Elevated haematocrit (HCT) levels (>50%)
2.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])
3.Men with a past/present or family history of male breast cancer
4.Women with a past/present history of breast cancer.
5.Pre-existing androgenic signs or symptoms in women of concern to either subject or investigator (deep voice, hirsutism, acne, androgenic hair loss).
6.Depression (Yesavage Geriatric Depression Scale (GDS) Score > 12)
7.Significant cardiac failure (New York Heart Association (NYHA) functional classification system Class III and above)
8.Abnormal liver function tests ( Alanine transaminase ALT, Gamma-glutamyltransferase GGT, bilirubin or alkaline phosphatase test ALP > 2x upper limit of normal)
9.Nephrotic syndrome; 24h urine protein > 3 grams (24h urine save performed if dipstick positive proteinuria at screening) AND/OR estimated/calculated creatinine clearance (by the equation of Baracskay and Jarkoura for ambulatory elderly subjects [Cr clearance = 4.4/serum creatinine (mmol/L) + (88-age)] < 30 ml/min AND/OR serum creatinine concentration > 0.2mmol/l.
10.Any disease, which in the opinion of the investigator is likely to lead to death within 1 year
11.Folstein’s Mini Mental State Examination [MMSE] score of < 23
12.Testosterone or other androgen therapy in the four months before starting the study.
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Study type Interventional
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Purpose of the study Treatment
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Allocation to intervention Randomised controlled trial
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Describe the procedure for enrolling a subject and allocating the treatment (allocation concealment procedures) Method 1: Domiciliary/geriatric assessment services at the three campuses will approach new clients about their willingness to consider participation in this study and be approached by researchers.

Method 2: Using similar approaches, investigator clinicians and other geriatrician/gerontology colleagues will refer consenting subjects from their rehabilitative, ambulatory or outreach services for further contact and review by the research officer. Any subjects who have only recently been in hospital will be enrolled into the study 3 months after the last hospitalization and once health status is stabilized.

Method 3: Television or newspaper advertisement.

Allocation involved contacting the holder of the allocation schedule who was off-site.
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Describe the methods used to generate the sequence in which subjects will be randomised (sequence generation) Subjects will be randomised to one of two study groups (n= ˜100/group) by a stratification system to ensure that an equal number of men and women will be allocated to each treatment. There will be stratification by study site to allow for possible differences in subjects recruited between sites, within each sex at each site.
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Masking / blinding Blinded (masking used)
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Who is / are masked / blinded (choose all that apply)


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Assignment Parallel
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Other design features
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Type of endpoint(s) Efficacy
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Statistical Methods/Analysis
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Phase Phase 4
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Anticipated date of first participant enrolment 1/05/2010
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Date of first participant enrolment
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Anticipated date last participant recruited/enrolled
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Actual date last participant recruited/enrolled
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Target sample size 200
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Recruitment status Not yet recruiting
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Recruitment in Australia

Recruitment state(s)
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Recruitment outside Australia

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Funding Source: Government body 256693 0
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Name: National Health and Medical Research Council NHMRC 256693 0
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Address: The Council Secretary NHMRC GPO Box 1421. CANBERRA ACT 2601. 256693 0
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Country: Australia 256693 0
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Primary Sponsor University
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Name: University of Adelaide
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Address: Department of Medicine
The Queen Elizabeth Hospital,
28 Woodville Road
Woodville South, SA 5011
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Country: Australia
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Secondary Sponsor: Government body 255981 0
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Name: Sydney Southwest Area Health Service 255981 0
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Address: Concord Hospital
Hospital Road, Concord
NSW 2139
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Country: Australia 255981 0
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Secondary Sponsor: Government body 255982 0
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Name: Alfred Health 255982 0
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Address: Division of Rehabilitation, Aged and Community Care
c/o Caulfield Hospital
260 Kooyong Road, Caulfield 3162
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Country: Australia 255982 0
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Has the study received approval from at least one Ethics Committee? Yes
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Ethics Committee name: Central Northern Adelaide Health Service Ethics of Human Research Committee The Queen Elizabeth Hospital and Lyell McEwin 258711 0
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Address: The Queen Elizabeth Hospital Woodville Road
Woodville South SA 5011
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Country: Australia 258711 0
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Approval Date: 258711 0
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Submitted Date: 258711 0
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HREC: 258711 0
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Brief summary Weight loss and under-nutrition is common in older people and associated with poor outcomes. This includes increased rates of hospital admissions.
In a pilot study of ndernourished older, community dwelling people we found that daily treatment for one year with a combination of testosterone tablets and a nutritional supplement produced a significant reduction in hospitalizations. We propose a larger, multicentre study to explore and hopefully confirm this exciting, potentially important finding.
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Trial website
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Trial related presentations / publications
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Public Notes
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Principal Investigator
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Contact person for public queries
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Name: Dr Cynthia Piantadosi
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Address: Department of Medicine The Queen Elizabeth Hospital Woodville Road Woodville South SA 5011
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Country: Australia
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Tel: +61 8 81334014
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Email: cynthia.piantadosi@adelaide.edu.au
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Contact person for scientific queries
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Name: A/Professor Renuka Visvanathan
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Address: Director, Aged & Extended Care Services Level 8b The Queen Elizabeth Hospital Woodville Road Woodville South SA 5011
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Country: Australia
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Tel: +61 8 82226887
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Email: renuka.visvanathan@adelaide.edu.au
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Contact person responsible for updating information
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Name: A/Professor Renuka Visvanathan
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Address: Director, Aged & Extended Care Services Level 8b The Queen Elizabeth Hospital Woodville Road Woodville South SA 5011
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Country: Australia
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Tel: +61 8 82226887
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Email: renuka.visvanathan@adelaide.edu.au
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Addition Cancer fields
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