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

NCT ID: NCT00560729

Last Updated: 2013-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

63 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-10-31

Study Completion Date

2007-07-31

Brief Summary

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

Detailed Description

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Conditions

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Denutrition

Keywords

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elderly people

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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I

Group Type NO_INTERVENTION

No interventions assigned to this group

II

oral nutrition

Group Type ACTIVE_COMPARATOR

Renutryl 500

Intervention Type DIETARY_SUPPLEMENT

III

oral nutrition

Group Type EXPERIMENTAL

Generique

Intervention Type DIETARY_SUPPLEMENT

IV

oral nutrition

Group Type EXPERIMENTAL

Generique + Renutryl 500

Intervention Type DIETARY_SUPPLEMENT

Interventions

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Renutryl 500

Intervention Type DIETARY_SUPPLEMENT

Generique

Intervention Type DIETARY_SUPPLEMENT

Generique + Renutryl 500

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Société des Produits Nestlé (SPN)

INDUSTRY

Sponsor Role lead

Principal Investigators

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Christian Aussel, PhD

Role: STUDY_DIRECTOR

University PARIS V

Locations

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Hôpital Georges Clemenceau

Champcueil, , France

Site Status

Hopital Emile Roux

Limeil-Brévannes, , France

Site Status

Hopital Charles RICHET

Villiers-le-Bel, , France

Site Status

Countries

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France

Other Identifiers

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NCNF 0402

Identifier Type: -

Identifier Source: org_study_id