ClinicalTrials.gov
ClinicalTrials.gov Menu

The Effects of Testosterone and Nutritional Supplementation in the Undernourished Elderly

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00117000
Recruitment Status : Unknown
Verified September 2006 by University of Adelaide.
Recruitment status was:  Active, not recruiting
First Posted : July 1, 2005
Last Update Posted : September 11, 2006
Sponsor:
Collaborator:
Organon
Information provided by:
University of Adelaide

Study Description
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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.

Condition or disease Intervention/treatment Phase
Malnutrition Aging Drug: testosterone undecanoate Phase 3

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.

Study Design
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type : Interventional  (Clinical Trial)
Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double
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
Study Start Date : July 2003
Study Completion Date : February 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information


Outcome Measures
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Days in hospital
  2. SF-36 quality of life scores (composite physical component score and composite mental component score).

Secondary Outcome Measures :
  1. Body composition
  2. Muscle strength
  3. Number of falls
  4. Functional status (living arrangements, activities of daily living and frailty scale scores)
  5. Mortality

Eligibility Criteria
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00117000     History of Changes
Other Study ID Numbers: 030320
First Posted: July 1, 2005    Key Record Dates
Last Update Posted: September 11, 2006
Last Verified: September 2006

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

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