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

This study has been terminated.
Sponsor:
Information provided by:
Nestlé
ClinicalTrials.gov Identifier:
NCT00560729
First received: November 6, 2007
Last updated: November 18, 2013
Last verified: November 2013

November 6, 2007
November 18, 2013
October 2003
July 2007   (final data collection date for primary outcome measure)
Nutritional Risk Index [ Time Frame: At J0, J21, J42 ]
Same as current
Complete list of historical versions of study NCT00560729 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Effectiveness and Cost of a Quantitative and Qualitative Nutritional Supplementation in Elderly Patients
Effectiveness and Cost of a Quantitative and Qualitative Nutritional Supplementation in Elderly Patients

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

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Denutrition
  • Dietary Supplement: Renutryl 500
  • Dietary Supplement: Generique
  • Dietary Supplement: Generique + Renutryl 500
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
63
July 2007
July 2007   (final data collection date for primary outcome measure)

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
Both
70 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00560729
NCNF 0402
No
Not Provided
Nestlé
Not Provided
Study Director: Christian Aussel, PhD University PARIS V
Nestlé
November 2013

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