Status:
COMPLETED
Efficacy of a Special Oral Nutritional Supplement on Nutritional Status of Malnourished Elderly Patients
Lead Sponsor:
University Hospital, Rouen
Conditions:
Malnutrition
Eligibility:
All Genders
60-95 years
Phase:
NA
Brief Summary
The aim of this study is to evaluate in malnourished elderly patients the nutritional efficacy of a new nutritional supplement enriched in different specific pharmaco nutrients (leucine, micronutrient...
Detailed Description
Ageing of the population and loss of autonomy expose to major consequences in terms of treatment charges and need for hospitalisation. Malnutrition has a key prognostic value, that worsen the prognosi...
Eligibility Criteria
Inclusion
- Both male and female participants
- Moderately malnourished defined by whether:
- 18 \< BMI \< 21
- 5 to 10% body weight loss in the last past 6 months.
- Buzby index between 83.5 and 97.5 (calculated with weight loss and albumin)
- With or without any factors increasing malnutrition (insufficient caloric intakes, long term treatment)
- Justifying hospitalisation in rehabilitation unit
Exclusion
- Age \< 70 years old or \> 90 years old
- Surgical affection involving a surgery in the next 10 days
- Contraindicated oral intakes due to digestive injury
- Total parenteral nutrition
- Ulcer or infection existing
- Malignant hemopathy
- Hepatic insufficiency (TP \< 30%)
- Swallowing difficulties limiting solid oral intakes
- Kidney failure (renal dialysis)
- Expected survival \> 3 months
- Impossibility to give an informed consent
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2011
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00877578
Start Date
April 1 2009
End Date
July 1 2011
Last Update
October 16 2013
Active Locations (2)
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1
Centre Hospitalier de Dieppe
Dieppe, France, 76200
2
UHRouen
Rouen, France, 76031