NCT00560729

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
63

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Oct 2003

Typical duration for phase_3

Geographic Reach
1 country

3 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2003

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2007

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 6, 2007

Completed
14 days until next milestone

First Posted

Study publicly available on registry

November 20, 2007

Completed
Last Updated

November 19, 2013

Status Verified

November 1, 2013

Enrollment Period

3.8 years

First QC Date

November 6, 2007

Last Update Submit

November 18, 2013

Conditions

Denutrition

Keywords

elderly people

Outcome Measures

Primary Outcomes (1)

  • Nutritional Risk Index

    At J0, J21, J42

Secondary Outcomes (2)

  • 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

Study Arms (4)

I

NO INTERVENTION

II

ACTIVE COMPARATOR

oral nutrition

Dietary Supplement: Renutryl 500

III

EXPERIMENTAL

oral nutrition

Dietary Supplement: Generique

IV

EXPERIMENTAL

oral nutrition

Dietary Supplement: Generique + Renutryl 500

Interventions

Renutryl 500DIETARY_SUPPLEMENT
II
GeneriqueDIETARY_SUPPLEMENT
III
Generique + Renutryl 500DIETARY_SUPPLEMENT
IV

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Hospitalization into a geriatric care unit
  • age \> 70 years
  • C reactive protein \> 30 mg/l
  • \< albumin \< 35 g/l
  • \< Na \< 145 mmol/l
  • BMI \< 22
  • weight loss \> 10 % within the last 6 months
  • MNA \< 23.5

You may not qualify if:

  • diabetes mellitus
  • severe digestive failure
  • enteral or parenteral nutrition
  • renal,cardiac or digestive failure
  • lactose intolerance
  • terminal phase severe pathology
  • MMS \< 15

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Hôpital Georges Clemenceau

Champcueil, 91750, France

Location

Hopital Emile Roux

Limeil-Brévannes, 94456, France

Location

Hopital Charles RICHET

Villiers-le-Bel, 95400, France

Location

Study Officials

  • Christian Aussel, PhD

    University PARIS V

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 6, 2007

First Posted

November 20, 2007

Study Start

October 1, 2003

Primary Completion

July 1, 2007

Study Completion

July 1, 2007

Last Updated

November 19, 2013

Record last verified: 2013-11

Locations

FR(3)