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Effectiveness and Cost of a Quantitative and Qualitative Nutritional Supplementation in Elderly Patients
This study has been completed.
Sponsored by: Nestle Clinical Nutrition
Information provided by: Nestle Clinical Nutrition
ClinicalTrials.gov Identifier: NCT00560729
  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 III

MedlinePlus related topics: Dietary Supplements
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title: Effectiveness and Cost of a Quantitative and Qualitative Nutritional Supplementation in Elderly Patients

Further study details as provided by Nestle Clinical Nutrition:

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
I: No Intervention
II: Active Comparator
oral nutrition
Dietary Supplement: Renutryl 500
III: Experimental
oral nutrition
Dietary Supplement: Generique
IV: Experimental
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
Hopital Charles RICHET
Villiers Le Bel, France, 95400
Hopital Emile Roux
Limeil Brevannes, France, 94456
Hôpital Georges Clemenceau
CHAMPCUEIL, France, 91750
Sponsors and Collaborators
Nestle Clinical Nutrition
Investigators
Study Director: Christian Aussel, PhD University PARIS V
  More Information

Study ID Numbers: NCNF 0402
Study First Received: November 6, 2007
Last Updated: November 19, 2007
ClinicalTrials.gov Identifier: NCT00560729  
Health Authority: France: Afssaps - French Health Products Safety Agency

Keywords provided by Nestle Clinical Nutrition:
elderly people

ClinicalTrials.gov processed this record on January 15, 2009



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