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

November 18, 2013 updated by: Nestlé
Evaluation of the effectiveness and the costs of a quantitative and qualitative nutritional supplementation in elderly patients

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

63

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Champcueil, France, 91750
        • Hôpital Georges Clemenceau
      • Limeil Brevannes, France, 94456
        • Hôpital Emile Roux
      • Villiers Le Bel, France, 95400
        • Hopital Charles RICHET

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

70 years and older (OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Hospitalization into a geriatric care unit
  • age > 70 years
  • C reactive 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: I
ACTIVE_COMPARATOR: II
oral nutrition
Dietary supplement: Renutryl 500
EXPERIMENTAL: III
oral nutrition
Dietary supplement: Generique
EXPERIMENTAL: IV
oral nutrition
Dietary supplement: Generique + Renutryl 500

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Nutritional Risk Index
Time Frame: At J0, J21, J42
At J0, J21, J42

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Daily

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nestlé

Investigators

  • Study Director: Christian Aussel, PhD, University PARIS V

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2003

Primary Completion (ACTUAL)

July 1, 2007

Study Completion (ACTUAL)

July 1, 2007

Study Registration Dates

First Submitted

November 6, 2007

First Submitted That Met QC Criteria

November 19, 2007

First Posted (ESTIMATE)

November 20, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

November 19, 2013

Last Update Submitted That Met QC Criteria

November 18, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • NCNF 0402

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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