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

History of Changes

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:

MedlinePlus related topics: Dietary Supplements Malnutrition

Drug Information available for: Testosterone propionate Methyltestosterone Testosterone cypionate Testosterone Testosterone enanthate Testosterone undecanoate

U.S. FDA Resources

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 (Adult, Senior)
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

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

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.


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:


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

ClinicalTrials.gov processed this record on September 27, 2016

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