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Clinical Trials/NCT01810263
NCT01810263
Terminated
Phase 2

The Efficacy of Intensive Nutritional Supplement in Patient With Stroke: a Prospective Randomized Controlled Trial

Seoul National University Bundang Hospital1 site in 1 country34 target enrollmentMay 2012

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Stroke
Sponsor
Seoul National University Bundang Hospital
Enrollment
34
Locations
1
Primary Endpoint
Modified Barthel Index (MBI) Score at 6 Months
Status
Terminated
Last Updated
10 years ago

Overview

Brief Summary

The aim of this prospective randomized controlled study is to demonstrate the efficacy of Intensive Nutritional Supplement in Patient with Stroke.

Detailed Description

Elderly patients, including those who have had a stroke, are more at risk of undernutrition than other groups because of reduced nutritional reserves, prolonged hospital stay and increased demands of repeated ill-health. Stroke may compound these problems because of physical and mental incapacity, problems with perception and communication, and swallowing disorders. The full extent of undernutrition and its independent contribution to stroke outcome is not presently known. It is also not known whether it can be corrected, and whether doing so would improve the outcome. The aim of this study is therefore to describe the efficacy of Intensive Nutritional Supplement in Patient with Stroke.

Registry
clinicaltrials.gov
Start Date
May 2012
End Date
July 2014
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Nam-Jong Paik

professor

Seoul National University Bundang Hospital

Eligibility Criteria

Inclusion Criteria

  • 1 st onset stroke patient
  • MRI confirms his/her stroke
  • more than 2.5% weight los within 2 weeks
  • initial serum albumin \< 35 g/l
  • BMI \< 18.5
  • more than MMSE 10
  • medically stable

Exclusion Criteria

  • recurrent stroke patient
  • malabsorption patient
  • terminal cancer

Outcomes

Primary Outcomes

Modified Barthel Index (MBI) Score at 6 Months

Time Frame: 6 months

Scale range: 0-100 (higher values represent a better outcome)

Secondary Outcomes

  • Chemical Laboratory Findings(6 months)

Study Sites (1)

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