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

Nestlé

Status and phase: Terminated; Phase 3

Conditions: Denutrition

Treatments: Dietary Supplement: Generique; Dietary Supplement: Renutryl 500; Dietary Supplement: Generique + Renutryl 500

Study type: Interventional

Funder types: Industry

Identifiers

NCT00560729

NCNF 0402

Details and patient eligibility

About

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

Enrollment: 63 patients

Sex: All

Ages: 70+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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63 participants in 4 patient groups

I

No Intervention group

II

Active Comparator group

Description:

oral nutrition

Treatment:

Dietary Supplement: Renutryl 500

III

Experimental group

Description:

oral nutrition

Treatment:

Dietary Supplement: Generique

IV

Experimental group

Description:

oral nutrition

Treatment:

Dietary Supplement: Generique + Renutryl 500