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

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ClinicalTrials.gov Identifier: NCT00560729
Recruitment Status : Terminated
First Posted : November 20, 2007
Last Update Posted : November 19, 2013
Sponsor:
Information provided by:
Nestlé

Brief Summary:
Evaluation of the effectiveness and the costs of a quantitative and qualitative nutritional supplementation in elderly patients

Condition or disease Intervention/treatment Phase
Denutrition Dietary Supplement: Renutryl 500 Dietary Supplement: Generique Dietary Supplement: Generique + Renutryl 500 Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 63 participants
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
Study Start Date : October 2003
Actual Primary Completion Date : July 2007
Actual Study Completion Date : July 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



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

Secondary Outcome Measures :
  1. 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.
  2. Tolerance [ Time Frame: Daily ]


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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

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

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

Keywords provided by Nestlé:
elderly people