Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000356066
Ethics application status
Approved
Date submitted
26/04/2010
Date registered
4/05/2010
Date last updated
9/02/2021
Date data sharing statement initially provided
9/02/2021
Date results information initially provided
9/02/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of testosterone and a nutritional supplement on hospital admissions in under-nourished, older people.
Scientific title
The effect of testosterone and a nutritional supplement on hospital admissions in under-nourished, older people.
Secondary ID [1] 251667 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Hospitalization 257008 0
Quality of Life Years 257015 0
Body Composition 257018 0
Frailty Score 257019 0
Nutrition Score 257020 0
Strength in under-nourished, older people. 257021 0
Condition category
Condition code
Diet and Nutrition 257411 257411 0 0
Obesity
Metabolic and Endocrine 257413 257413 0 0
Normal metabolism and endocrine development and function

Intervention/exposure
Study type
Interventional
Description 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.
Intervention code [1] 256192 0
Treatment: Drugs
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
Control group
Placebo

Outcomes
Primary outcome [1] 258066 0
Days in hospital and number of hospital admissions assessed by telephone contact with participant.
Timepoint [1] 258066 0
12 months following randomisation.
Primary outcome [2] 258067 0
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.
Timepoint [2] 258067 0
12 months following randomisation
Secondary outcome [1] 263646 0
Nutritional Health assessed by questionnaires and blood tests.
Timepoint [1] 263646 0
3, 6 and 12 months following randomisation.
Secondary outcome [2] 263652 0
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).
Timepoint [2] 263652 0
Baseline, 6 and 12 months following randomisation.
Secondary outcome [3] 263653 0
Frailty Score assessed by questionnaire Fried?s Frailty Scale.
Timepoint [3] 263653 0
Baseline, 6 and 12 months following randomisation.
Secondary outcome [4] 263654 0
Grip Strength assessed by hand grip dynamometer test
Timepoint [4] 263654 0
Baseline, 6 and 12 months following randomisation.
Secondary outcome [5] 263655 0
Fat Free Mass assessed by Bioelectrical Impedance analysis (BIA).
Timepoint [5] 263655 0
Baseline and 12 months following randomisation.

Eligibility
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.
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
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.
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.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/05/2010
Actual
1/05/2010
Date of last participant enrolment
Anticipated
Actual
30/06/2014
Date of last data collection
Anticipated
Actual
30/06/2015
Sample size
Target
200
Accrual to date
Final
53
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC

Funding & Sponsors
Funding source category [1] 256693 0
Government body
Name [1] 256693 0
National Health and Medical Research Council NHMRC
Country [1] 256693 0
Australia
Primary sponsor type
University
Name
University of Adelaide
Address
Department of Medicine
The Queen Elizabeth Hospital,
28 Woodville Road
Woodville South, SA 5011
Country
Australia
Secondary sponsor category [1] 255981 0
Government body
Name [1] 255981 0
Sydney Southwest Area Health Service
Address [1] 255981 0
Concord Hospital
Hospital Road, Concord
NSW 2139
Country [1] 255981 0
Australia
Secondary sponsor category [2] 255982 0
Government body
Name [2] 255982 0
Alfred Health
Address [2] 255982 0
Division of Rehabilitation, Aged and Community Care
c/o Caulfield Hospital
260 Kooyong Road, Caulfield 3162
Country [2] 255982 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258711 0
Central Northern Adelaide Health Service Ethics of Human Research Committee The Queen Elizabeth Hospital and Lyell McEwin
Ethics committee address [1] 258711 0
The Queen Elizabeth Hospital Woodville Road
Woodville South SA 5011
Ethics committee country [1] 258711 0
Australia
Date submitted for ethics approval [1] 258711 0
Approval date [1] 258711 0
Ethics approval number [1] 258711 0

Summary
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.
Trial website
Trial related presentations / publications
BMC Geriatr. 2011 Oct 24;11:66. doi: 10.1186/1471-2318-11-66.
The effect of testosterone and a nutritional supplement on hospital admissions in under-nourished, older people. Piantadosi C1, Visvanathan R, Naganathan V, Hunter P, Cameron ID, Lange K, Karnon J, Chapman IM.

J Nutr Health Aging. 2016;20(7):769-79. doi: 10.1007/s12603-016-0689-y.
The Randomized Control Trial of the Effects of Testosterone and a Nutritional Supplement On Hospital Admissions in Undernourished, Community Dwelling, Older People.
Visvanathan R1, Piantadosi C, Lange K, Naganathan V, Hunter P, Cameron ID, Chapman I.

J Nutr Health Aging. 2016;20(7):769-79. doi: 10.1007/s12603-016-0689-y.
The Randomized Control Trial of the Effects of Testosterone and a Nutritional Supplement On Hospital Admissions in Undernourished, Community Dwelling, Older People.
Visvanathan R1, Piantadosi C, Lange K, Naganathan V, Hunter P, Cameron ID, Chapman I.

BMC Res Notes. 2015 Apr 15;8:151. doi: 10.1186/s13104-015-1113-0.
Recruiting older people at nutritional risk for clinical trials: what have we learned?
Piantadosi C1, Chapman IM2, Naganathan V3, Hunter P4, Cameron ID5, Visvanathan R6,7,8.
Public notes

Contacts
Principal investigator
Name 30970 0
Prof Ian Chapman
Address 30970 0
Department of Medicine, Level 6, Eleanor Harrald Building, Frome Road, University of Adelaide, SA 5000
Country 30970 0
Australia
Phone 30970 0
08-82224000
Fax 30970 0
Email 30970 0
[email protected]
Contact person for public queries
Name 14217 0
Professor Renuka Visvanathan
Address 14217 0
Department of Medicine
The Queen Elizabeth Hospital Woodville Road
Woodville South SA 5011
Country 14217 0
Australia
Phone 14217 0
+61 8 82226000
Fax 14217 0
Email 14217 0
[email protected]
Contact person for scientific queries
Name 5145 0
Professor Renuka Visvanathan
Address 5145 0
Director, Aged & Extended Care Services Level 8b
The Queen Elizabeth Hospital Woodville Road
Woodville South SA 5011
Country 5145 0
Australia
Phone 5145 0
+ 61 8 82226000
Fax 5145 0
Email 5145 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
10518Study protocolThe effect of testosterone and a nutritional supplement on hospital admissions in under-nourished, older people. Piantadosi C, Visvanathan R, Naganathan V, Hunter P, Cameron ID, Lange K, Karnon J, Chapman IM. BMC Geriatr. 2011 Oct 24;11:66. doi: 10.1186/1471-2318-11-66.  
10519Clinical study reportThe Randomized Control Trial of the Effects of Testosterone and a Nutritional Supplement On Hospital Admissions in Undernourished, Community Dwelling, Older People. Visvanathan R, Piantadosi C, Lange K, Naganathan V, Hunter P, Cameron ID, Chapman I. J Nutr Health Aging. 2016;20(7):769-79. doi: 10.1007/s12603-016-0689-y.  
10520OtherCan an Intervention with Testosterone and Nutritional Supplement Improve the Frailty Level of Under-Nourished Older People? Theou O, Chapman I, Wijeyaratne L, Piantadosi C, Lange K, Naganathan V, Hunter P, Cameron ID, Rockwood K, Visvanathan R. J Frailty Aging. 2016;5(4):247-252. doi: 10.14283/jfa.2016.108.   Provided below



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Visvanathan R et. al. The Randomized Control Trial... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseThe effect of testosterone and a nutritional supplement on hospital admissions in under-nourished, older people.2011
EmbaseRecruiting older people at nutritional risk for clinical trials: what have we learned?.2015https://dx.doi.org/10.1186/s13104-015-1113-0
EmbaseThe randomized control trial of the effects of testosterone and a nutritional supplement on hospital admissions in undernourished, community dwelling, older people.2016https://dx.doi.org/10.1007/s12603-016-0689-y
N.B. These documents automatically identified may not have been verified by the study sponsor.