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

Phase 3

Terminated

• Conditions: Denutrition

• Registration Number: NCT00560729
• Lead Sponsor: Société des Produits Nestlé (SPN)

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2003-10
• Primary Completion: 2007-07
• Study Completion: 2007-07
• Study First Submitted: 2007-11-06
• Study First Submitted QC: 2007-11-19
• Study First Posted: 2007-11-20
• Status Verified: 2013-11
• Last Update Submitted: 2013-11-18
• Last Update Posted: 2013-11-19

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 63

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Nutritional Risk Index	At J0, J21, J42

Secondary Outcome Measures

Name	Time	Method
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	Daily

Trial Locations

Locations (3)

Hôpital Georges Clemenceau; 🇫🇷 Champcueil, France

Hopital Emile Roux; 🇫🇷 Limeil Brevannes, France

Hopital Charles RICHET; 🇫🇷 Villiers Le Bel, France