The Effects of Testosterone and Nutritional Supplementation in the Undernourished Elderly - Full Text View

Sponsors and Collaborators:	University of Adelaide Organon
Information provided by:	University of Adelaide
ClinicalTrials.gov Identifier:	NCT00117000

Sponsors and Collaborators:

University of Adelaide
Organon

Information provided by:

University of Adelaide

ClinicalTrials.gov Identifier:

NCT00117000

Purpose

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.

Condition	Intervention	Phase
Malnutrition Aging	Drug: testosterone undecanoate	Phase III

MedlinePlus related topics: Dietary Supplements

Drug Information available for: Testosterone Methyltestosterone Oxymesterone Testosterone enanthate Testosterone Propionate Testosterone undecanoate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Factorial Assignment, Safety/Efficacy Study
Official Title:	The Effects of Testosterone and Nutritional Supplementation, Alone and Combined, on the Adverse Effects of Under-Nutrition in the Elderly

Further study details as provided by University of Adelaide:

Primary Outcome Measures:

Days in hospital
SF-36 quality of life scores (composite physical component score and composite mental component score).

Secondary Outcome Measures:

Body composition
Muscle strength
Number of falls
Functional status (living arrangements, activities of daily living and frailty scale scores)
Mortality

Estimated Enrollment:	200
Study Start Date:	July 2003
Estimated Study Completion Date:	February 2007

Detailed 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.

Eligibility

Ages Eligible for Study:	65 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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 ID Numbers:	030320
Study First Received:	June 30, 2005
Last Updated:	September 7, 2006
ClinicalTrials.gov Identifier:	NCT00117000
Health Authority:	Australia: Department of Health and Ageing Therapeutic Goods Administration

Australia, South Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia, 5000