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Effect of Intensive Nutritional Support in Subacute Stroke Patient

Sponsor
Samsung Medical Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT04259307
Collaborator
Korean Center for Disease Control and Prevention (Other)
150
Enrollment
1
Location
2
Arms
47
Anticipated Duration (Months)
3.2
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Omapone Peri 724mL or Winuf Peri 654mL
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
150 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Effect of Intensive Nutritional Support on Functional Recovery in Subacute Stroke Patient
Actual Study Start Date :
Jan 29, 2020
Anticipated Primary Completion Date :
Aug 31, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intensive nutrition group

Standard nutritional support with additional intravenous nutrition of 500 kcal per day for 3 weeks

Drug: Omapone Peri 724mL or Winuf Peri 654mL
Additional intravenous nutrition of 500 kcal per day for 3 weeks
Other Names:
  • Comprehensive rehabilitation

    		•
    No Intervention: Control group

    Standard nutritional support only per day for 3 weeks

    Outcome Measures

    Primary Outcome Measures

    1. Korean modified Barthel Index (K-MBI) at 6 months after onset [6 months after onset]

      Korean modified Barthel Index (0~100)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Samsung Medical Center Seoul Korea, Republic of 135-710

    Sponsors and Collaborators

    • Samsung Medical Center
    • Korean Center for Disease Control and Prevention

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Won Hyuk Chang, Associate Professor, Samsung Medical Center
    ClinicalTrials.gov Identifier:
    NCT04259307
    Other Study ID Numbers:
    • 2019-06-109
    First Posted:
    Feb 6, 2020
    Last Update Posted:
    May 9, 2022
    Last Verified:
    May 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Stroke

    Study Results

    No Results Posted as of May 9, 2022