The Effects of Testosterone and Nutritional Supplementation in the Undernourished Elderly
Recruitment status was Active, not recruiting
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Primary Purpose: Treatment
|Official Title:||The Effects of Testosterone and Nutritional Supplementation, Alone and Combined, on the Adverse Effects of Under-Nutrition in the Elderly|
- Days in hospital
- SF-36 quality of life scores (composite physical component score and composite mental component score).
- Body composition
- Muscle strength
- Number of falls
- Functional status (living arrangements, activities of daily living and frailty scale scores)
|Study Start Date:||July 2003|
|Estimated Study Completion Date:||February 2007|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00117000
|Australia, South Australia|
|Royal Adelaide Hospital|
|Adelaide, South Australia, Australia, 5000|
|Principal Investigator:||Ian M Chapman, MBBS, PhD||University of Adelaide|