The Effects of Testosterone and Nutritional Supplementation in the Undernourished Elderly

Aging Clinical Trial

Official title:

The Effects of Testosterone and Nutritional Supplementation, Alone and Combined, on the Adverse Effects of Under-Nutrition in the Elderly

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00117000
• Other study ID #: 030320
• Status: Active, not recruiting
• Phase: Phase 3
• First received: June 30, 2005
• Last updated: September 7, 2006
• Start date: July 2003
• Est. completion date: February 2007

Study information

• Verified date: September 2006
• Source: University of Adelaide
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: February 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Aging
• Malnutrition

Intervention

Drug:
• testosterone undecanoate

Locations

Country	Name	City	State
Australia	Royal Adelaide Hospital	Adelaide	South Australia

Sponsors (2)

Lead Sponsor	Collaborator
University of Adelaide	Organon

Country where clinical trial is conducted

Australia, 

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* Note: There are 69 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Days in hospital
Primary	SF-36 quality of life scores (composite physical component score and composite mental component score).
Secondary	Body composition
Secondary	Muscle strength
Secondary	Number of falls
Secondary	Functional status (living arrangements, activities of daily living and frailty scale scores)
Secondary	Mortality