Back to resultsEffect of Intensive Nutritional Support in Subacute Stroke Patient
Primary Purpose
Stroke, Rehabilitation, Nutrition
Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Omapone Peri 724mL or Winuf Peri 654mL
Sponsored by
About this trial
This is an interventional treatment trial for Stroke
Eligibility Criteria
Inclusion Criteria:
Acute first-ever stroke patients less than 7 days after onset
more than 19 years old at stroke onset ③ stroke confirmed by brain CT or MRI
- body mass index (BMI) <25 before the comprehensive rehabilitation ⑤ Mini Nutritional Assessment < 12 before the comprehensive rehabilitation ⑥ Fugl-Meyer assessment < 85 at 7 days after stroke onset
Exclusion Criteria:
Transient ischemic stroke
Progressive or unstable stroke
Pre-existing and active major neurological disease, e.g., spinal cord injury, Parkinson's disease, et al.
Pre-existing and active (e.g., on chronic medication) major psychiatric disease, such as major depression, schizophrenia, bipolar disease or dementia ⑤ Advanced liver, kidney, cardiac, or pulmonary disease, e.g., advanced hepatocellular carcinoma, end-stage renal failure, et al.)
A terminal medical diagnosis consistent with survival < 1 year
- Diabetes mellitus, Hyperlipidemia, Metabolic syndrome, Heart failure) ⑧ Pregnant or lactating women ⑨ Prohibited from taking medication (Omapone Peri 724mL or Winuf Peri 654mL)
Sites / Locations
- Samsung Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intensive nutrition group
Control group
Arm Description
Standard nutritional support with additional intravenous nutrition of 500 kcal per day for 3 weeks
Standard nutritional support only per day for 3 weeks
Outcomes
Primary Outcome Measures
Korean modified Barthel Index (K-MBI) at 6 months after onset
Korean modified Barthel Index (0~100)
Secondary Outcome Measures
Full Information
NCT ID
NCT04259307
First Posted
February 4, 2020
Last Updated
May 5, 2022
Sponsor
Samsung Medical Center
Collaborators
Korean Center for Disease Control and Prevention
1. Study Identification
Unique Protocol Identification Number
NCT04259307
Brief Title
Effect of Intensive Nutritional Support in Subacute Stroke Patient
Official Title
Effect of Intensive Nutritional Support on Functional Recovery in Subacute Stroke Patient
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 29, 2020 (Actual)
Primary Completion Date
August 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Samsung Medical Center
Collaborators
Korean Center for Disease Control and Prevention
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Proper nutritional support during early rehabilitation may be beneficial for functional improvements in gaining functional independence and preventing complications in stroke patients. However, there was no consensus of proper amount of nutritional support in stroke patients. In this study, the investigators aimed to clarigy the effects of the intensive nutritional support during comprehensive rehabilitation during subacute phase to improve function in patients with first-ever strokes.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Rehabilitation, Nutrition
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intensive nutrition group
Arm Type
Experimental
Arm Description
Standard nutritional support with additional intravenous nutrition of 500 kcal per day for 3 weeks
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Standard nutritional support only per day for 3 weeks
Intervention Type
Drug
Intervention Name(s)
Omapone Peri 724mL or Winuf Peri 654mL
Other Intervention Name(s)
Comprehensive rehabilitation
Intervention Description
Additional intravenous nutrition of 500 kcal per day for 3 weeks
Primary Outcome Measure Information:
Title
Korean modified Barthel Index (K-MBI) at 6 months after onset
Description
Korean modified Barthel Index (0~100)
Time Frame
6 months after onset
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Acute first-ever stroke patients less than 7 days after onset
more than 19 years old at stroke onset ③ stroke confirmed by brain CT or MRI
body mass index (BMI) <25 before the comprehensive rehabilitation ⑤ Mini Nutritional Assessment < 12 before the comprehensive rehabilitation ⑥ Fugl-Meyer assessment < 85 at 7 days after stroke onset
Exclusion Criteria:
Transient ischemic stroke
Progressive or unstable stroke
Pre-existing and active major neurological disease, e.g., spinal cord injury, Parkinson's disease, et al.
Pre-existing and active (e.g., on chronic medication) major psychiatric disease, such as major depression, schizophrenia, bipolar disease or dementia ⑤ Advanced liver, kidney, cardiac, or pulmonary disease, e.g., advanced hepatocellular carcinoma, end-stage renal failure, et al.)
A terminal medical diagnosis consistent with survival < 1 year
Diabetes mellitus, Hyperlipidemia, Metabolic syndrome, Heart failure) ⑧ Pregnant or lactating women ⑨ Prohibited from taking medication (Omapone Peri 724mL or Winuf Peri 654mL)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Won Hyuk Chang, MD.,PhD.
Phone
82-2-3410-6068
Email
wh.chang@samsung.com
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Won Hyuk Chang, Prof
Phone
82-2-3410-6068
Email
wh.chang@samsung.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effect of Intensive Nutritional Support in Subacute Stroke Patient
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