The Effects of Testosterone and Nutritional Supplementation in the Undernourished Elderly

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2006 by University of Adelaide.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Organon
Information provided by:
University of Adelaide
ClinicalTrials.gov Identifier:
NCT00117000
First received: June 30, 2005
Last updated: September 7, 2006
Last verified: September 2006
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00117000

Locations
Australia, South Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia, 5000
Sponsors and Collaborators
University of Adelaide
Organon
Investigators
Principal Investigator: Ian M Chapman, MBBS, PhD University of Adelaide
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00117000     History of Changes
Other Study ID Numbers: 030320
Study First Received: June 30, 2005
Last Updated: September 7, 2006
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by University of Adelaide:
testosterone
food, formulated
malnutrition
undernutrition
aging
aged
aged, 80 and over
frail elderly

Additional relevant MeSH terms:
Nutrition Disorders
Malnutrition
Testosterone
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Methyltestosterone
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Anabolic Agents

ClinicalTrials.gov processed this record on October 01, 2014