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

Denutrition Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00560729
• Other study ID #: NCNF 0402
• Status: Terminated
• Phase: Phase 3
• First received: November 6, 2007
• Last updated: November 18, 2013
• Start date: October 2003
• Est. completion date: July 2007

Study information

• Verified date: November 2013
• Source: Nestlé
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 63
• Est. completion date: July 2007
• Est. primary completion date: July 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 70 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Denutrition

Intervention

Dietary Supplement:
• Renutryl 500

• Generique

• Generique + Renutryl 500

Locations

Country	Name	City	State
France	Hôpital Georges Clemenceau	Champcueil
France	Hopital Emile Roux	Limeil Brevannes
France	Hopital Charles RICHET	Villiers Le Bel

Sponsors (1)

Lead Sponsor	Collaborator
Nestlé

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Nutritional Risk Index		At J0, J21, J42
Secondary	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.
Secondary	Tolerance		Daily