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The Efficacy of Intensive Nutritional Supplement in Patient With Stroke

Primary Purpose

Stroke, Malnutrition

Status
Terminated
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
high protein supplement
Sponsored by
Seoul National University Bundang Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring stroke, malnutrition, high protein

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Seoul National University Bundang Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

high protein supplement

Control

Arm Description

high protein supplement given

no intervention

Outcomes

Primary Outcome Measures

Modified Barthel Index (MBI) Score at 6 Months
Scale range: 0-100 (higher values represent a better outcome)

Secondary Outcome Measures

Chemical Laboratory Findings

Full Information

First Posted
February 1, 2013
Last Updated
July 1, 2015
Sponsor
Seoul National University Bundang Hospital
Collaborators
Myongji Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01810263
Brief Title
The Efficacy of Intensive Nutritional Supplement in Patient With Stroke
Official Title
The Efficacy of Intensive Nutritional Supplement in Patient With Stroke: a Prospective Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Terminated
Why Stopped
The study does not seem to provide benefits to patients.
Study Start Date
May 2012 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
July 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Bundang Hospital
Collaborators
Myongji Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Malnutrition
Keywords
stroke, malnutrition, high protein

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
high protein supplement
Arm Type
Experimental
Arm Description
high protein supplement given
Arm Title
Control
Arm Type
No Intervention
Arm Description
no intervention
Intervention Type
Dietary Supplement
Intervention Name(s)
high protein supplement
Other Intervention Name(s)
Intensive Nutritional Supplement group
Intervention Description
Dietary Supplement: high protein supplement
Primary Outcome Measure Information:
Title
Modified Barthel Index (MBI) Score at 6 Months
Description
Scale range: 0-100 (higher values represent a better outcome)
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Chemical Laboratory Findings
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
Body Mass Index
Time Frame
6 months
Title
Triceps Skin Fold Thickness
Time Frame
6 months
Title
Subjective Global Assessment
Time Frame
6 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nam-Jong Paik, MD, PhD
Organizational Affiliation
Department of Rehabilitation Medicine, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Seongnam, Korea
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Bundang Hospital
City
Seongnam-si
State/Province
Korea, Gyeonggi-do
ZIP/Postal Code
463-707
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
9771334
Citation
Gariballa SE, Parker SG, Taub N, Castleden M. Nutritional status of hospitalized acute stroke patients. Br J Nutr. 1998 Jun;79(6):481-7. doi: 10.1079/bjn19980085.
Results Reference
background
PubMed Identifier
3239449
Citation
Axelsson K, Asplund K, Norberg A, Alafuzoff I. Nutritional status in patients with acute stroke. Acta Med Scand. 1988;224(3):217-24. doi: 10.1111/j.0954-6820.1988.tb19364.x.
Results Reference
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The Efficacy of Intensive Nutritional Supplement in Patient With Stroke

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