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

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00560729
First Posted: November 20, 2007
Last Update Posted: November 19, 2013
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.
Information provided by:
Nestlé
  Purpose
Evaluation of the effectiveness and the costs of a quantitative and qualitative nutritional supplementation in elderly patients

Condition Intervention Phase
Denutrition Dietary Supplement: Renutryl 500 Dietary Supplement: Generique Dietary Supplement: Generique + Renutryl 500 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effectiveness and Cost of a Quantitative and Qualitative Nutritional Supplementation in Elderly Patients

Resource links provided by NLM:


Further study details as provided by Nestlé:

Primary Outcome Measures:
  • Nutritional Risk Index [ Time Frame: At J0, J21, J42 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 63
Study Start Date: October 2003
Study Completion Date: July 2007
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

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:   70 Years and older   (Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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): NCT00560729


Locations
France
Hôpital Georges Clemenceau
Champcueil, France, 91750
Hopital Emile Roux
Limeil Brevannes, France, 94456
Hopital Charles RICHET
Villiers Le Bel, France, 95400
Sponsors and Collaborators
Nestlé
Investigators
Study Director: Christian Aussel, PhD University PARIS V
  More Information

ClinicalTrials.gov Identifier: NCT00560729     History of Changes
Other Study ID Numbers: NCNF 0402
First Submitted: November 6, 2007
First Posted: November 20, 2007
Last Update Posted: November 19, 2013
Last Verified: November 2013

Keywords provided by Nestlé:
elderly people