Effectiveness and Cost of a Quantitative and Qualitative Nutritional Supplementation in Elderly Patients
Phase 3
Terminated
- Conditions
- Denutrition
- Interventions
- Dietary Supplement: GeneriqueDietary Supplement: Generique + Renutryl 500Dietary Supplement: Renutryl 500
- 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
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
- Arm && Interventions
Group Intervention Description III Generique oral nutrition IV Generique + Renutryl 500 oral nutrition II Renutryl 500 oral nutrition
- 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