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NCT00117000

The Effects of Testosterone and Nutritional Supplementation in the Undernourished Elderly

Last Updated: 2006-09-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-07-31

Study Completion Date

2007-02-28

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Malnutrition Aging

Keywords

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testosterone food, formulated malnutrition undernutrition aging aged aged, 80 and over frail elderly

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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testosterone undecanoate

Intervention Type DRUG

Eligibility Criteria

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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.

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

Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Principal Investigators

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Ian M Chapman, MBBS, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Adelaide

Locations

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Royal Adelaide Hospital

Adelaide, South Australia, Australia

Site Status

Countries

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Australia

References

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Chapman IM, Visvanathan R, Hammond AJ, Morley JE, Field JB, Tai K, Belobrajdic DP, Chen RY, Horowitz M. Effect of testosterone and a nutritional supplement, alone and in combination, on hospital admissions in undernourished older men and women. Am J Clin Nutr. 2009 Mar;89(3):880-9. doi: 10.3945/ajcn.2008.26538. Epub 2009 Jan 14.

Reference Type DERIVED

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Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

030320

Identifier Type: -

Identifier Source: org_study_id

The Effects of Testosterone and Nutritional Supplementation in the Undernourished Elderly

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Keywords

Study Design

Interventions

testosterone undecanoate

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Organon

University of Adelaide

Principal Investigators

Ian M Chapman, MBBS, PhD

Locations

Royal Adelaide Hospital

Countries

References

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