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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
  Purpose

Evaluation of the effectivness and the costs of a quantitaive 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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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:

U.S. FDA Resources

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
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

Ages Eligible for Study:   70 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00560729     History of Changes
Other Study ID Numbers: NCNF 0402
Study First Received: November 6, 2007
Last Updated: November 19, 2007
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Nestlé:
elderly people

ClinicalTrials.gov processed this record on May 23, 2013