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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00117000




Registration number
NCT00117000
Ethics application status
Date submitted
30/06/2005
Date registered
1/07/2005
Date last updated
11/09/2006

Titles & IDs
Public title
The Effects of Testosterone and Nutritional Supplementation in the Undernourished Elderly
Scientific title
The Effects of Testosterone and Nutritional Supplementation, Alone and Combined, on the Adverse Effects of Under-Nutrition in the Elderly
Secondary ID [1] 0 0
030320
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Malnutrition 0 0
Aging 0 0
Condition category
Condition code
Diet and Nutrition 0 0 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - testosterone undecanoate

Treatment: Drugs: testosterone undecanoate


Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Days in hospital
Timepoint [1] 0 0
Primary outcome [2] 0 0
SF-36 quality of life scores (composite physical component score and composite mental component score).
Timepoint [2] 0 0
Secondary outcome [1] 0 0
Body composition
Timepoint [1] 0 0
Secondary outcome [2] 0 0
Muscle strength
Timepoint [2] 0 0
Secondary outcome [3] 0 0
Number of falls
Timepoint [3] 0 0
Secondary outcome [4] 0 0
Functional status (living arrangements, activities of daily living and frailty scale scores)
Timepoint [4] 0 0
Secondary outcome [5] 0 0
Mortality
Timepoint [5] 0 0

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

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Factorial
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 0 0
5000 - Adelaide

Funding & Sponsors
Primary sponsor type
Other
Name
University of Adelaide
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Organon
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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 community-dwelling older men and women.
Trial website
https://clinicaltrials.gov/show/NCT00117000
Trial related presentations / publications
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Public notes

Contacts
Principal investigator
Name 0 0
Ian M Chapman, MBBS, PhD
Address 0 0
University of Adelaide
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT00117000