Effectiveness and Cost of a Quantitative and Qualitative Nutritional Supplementation in Elderly Patients

This study has been completed.

Sponsor:

Information provided by:

Nestlé

ClinicalTrials.gov Identifier:

NCT00560729

First received: November 6, 2007

Last updated: November 19, 2007

Last verified: November 2007

History of Changes

Tracking Information

First Received Date ^ICMJE

November 6, 2007

Last Updated Date

November 19, 2007

Start Date ^ICMJE

October 2003

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Nutritional Risk Index [ Time Frame: At J0, J21, J42 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00560729 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Measure of body mass index (BMI), Mini Nutritional Assessment, Fat mass,lean mass, serum albumin and transthyretin,Activities of Daily Living (ADL), ingesta and morbidity.
Tolerance [ Time Frame: Daily ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Effectiveness and Cost of a Quantitative and Qualitative Nutritional Supplementation in Elderly Patients

Official Title ^ICMJE

Effectiveness and Cost of a Quantitative and Qualitative Nutritional Supplementation in Elderly Patients

Brief Summary

Evaluation of the effectivness and the costs of a quantitaive and qualitative nutritional supplementation in elderly patients

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Denutrition

Intervention ^ICMJE

Dietary Supplement: Renutryl 500
Dietary Supplement: Generique
Dietary Supplement: Generique + Renutryl 500

Study Arm (s)

No Intervention: I
Active Comparator: II
oral nutrition

Intervention: Dietary Supplement: Renutryl 500
Experimental: III
oral nutrition

Intervention: Dietary Supplement: Generique
Experimental: IV
oral nutrition

Intervention: Dietary Supplement: Generique + Renutryl 500

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

July 2007

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Hospitalization into a geriatric care unit
age > 70 years
C reactiv protein > 30 mg/l
25 < albumin < 35 g/l
130 < Na < 145 mmol/l
BMI < 22
weight loss > 10 % within the last 6 months
MNA < 23.5

Exclusion Criteria:

diabetes mellitus
severe digestive failure
enteral or parenteral nutrition
renal,cardiac or digestive failure
lactose intolerance
terminal phase severe pathology
MMS < 15

Gender

Both

Ages

70 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

France

Administrative Information

NCT Number ^ICMJE

NCT00560729

Other Study ID Numbers ^ICMJE

NCNF 0402

Has Data Monitoring Committee

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Nestlé

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Christian Aussel, PhD

University PARIS V

Information Provided By

Nestlé

Verification Date

November 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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