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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00560729 |
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Date of registration:
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06/11/2007 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Effectiveness and Cost of a Quantitative and Qualitative Nutritional Supplementation in Elderly Patients
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Scientific title:
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Effectiveness and Cost of a Quantitative and Qualitative Nutritional Supplementation in Elderly Patients |
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Date of first enrolment:
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October 2003 |
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Target sample size:
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63 |
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Recruitment status: |
Terminated |
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URL:
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http://clinicaltrials.gov/show/NCT00560729 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 3
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Countries of recruitment
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France
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Contacts
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Name:
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Christian Aussel, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University PARIS V |
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Key inclusion & exclusion 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
Age minimum:
70 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Denutrition
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Intervention(s)
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Dietary Supplement: Generique
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Dietary Supplement: Generique + Renutryl 500
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Dietary Supplement: Renutryl 500
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Primary Outcome(s)
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Nutritional Risk Index
[Time Frame: At J0, J21, J42]
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Secondary Outcome(s)
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Tolerance
[Time Frame: Daily]
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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.
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Secondary ID(s)
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NCNF 0402
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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