Ignite Creation Date:
2024-05-05 @ 5:14 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00417508
Status:
TERMINATED
Last Update Posted:
2019-04-18
First Post:
2006-12-29
Brief Title:
Nutritional Intervention in Malnourished Elderly Patients
Sponsor:
University Hospital of North Norway
Organization:
University Hospital of North Norway
Study Overview
Official Title:
Effectiveness of Nutritional Intervention in Malnourished Elderly Patients
Status:
TERMINATED
Status Verified Date:
2012-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
It was not possible to recruite sufficient number of participants
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to investigate whether nutritional supplementation will improve functional outcome parameters and nutritional status in elderly patients
Detailed Description:
Malnutrition is still a problem in elderly patients and this may be associated with reduced muscle strength and ADL function activities of daily living Malnourished Medical InpatientsOutpatients and District Nurse patients with a Body Mass Index 20 kgm2 are asked to participate
Comparisons The patients are randomized to either ordinary dietary advice with a recommendation of four meals per day or similar dietary advice and two daily sip feeding supplements The study supplementation is Fresubin Protein Energy Drink and this will give additional 600 kcal and 40 gram protein a day The study period is 12 weeks with a visit at inclusion week 6 and week 12
Primary and secondary outcome parameters are measured at inclusion and week 12
Comparisons The patients are randomized to either ordinary dietary advice with a recommendation of four meals per day or similar dietary advice and two daily sip feeding supplements The study supplementation is Fresubin Protein Energy Drink and this will give additional 600 kcal and 40 gram protein a day The study period is 12 weeks with a visit at inclusion week 6 and week 12
Primary and secondary outcome parameters are measured at inclusion and week 12
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None