The Efficacy of Intensive Nutritional Supplement in Patient With Stroke

This study has been terminated.
(The study does not seem to provide benefits to patients.)
Sponsor:
Collaborator:
Myongji Hospital
Information provided by (Responsible Party):
Nam-Jong Paik, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier:
NCT01810263
First received: February 1, 2013
Last updated: July 1, 2015
Last verified: July 2015
Results First Received: May 18, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Stroke
Malnutrition
Intervention: Dietary Supplement: high protein supplement

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
  • first ever stroke
  • MRI confirms his/her stroke
  • weight loss over 2.5% within 2 weeks after the stroke onset
  • MMSE >= 10
  • medically stable

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
High Protein Supplement

Patients in the both groups keep on routine diet in the hospital All the patients in the High Protein Supplement group were provided additional calories of Nucare(High protein fluid diet, 200kcal/200ml/1 can. Dasang, Seoul, Korea) three times a day.

(As a result, additional calories are 600kcal a day)

Control Patients in the both groups keep on routine diet in the hospital. No additional calories are provided.

Participant Flow:   Overall Study
    High Protein Supplement     Control  
STARTED     16     18  
COMPLETED     8 [1]   11  
NOT COMPLETED     8     7  
Lost to Follow-up                 8                 7  
[1] 2014 July



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
High Protein Supplement high protein supplement given
Control no intervention
Total Total of all reporting groups

Baseline Measures
    High Protein Supplement     Control     Total  
Number of Participants  
[units: participants]
  16     18     34  
Age  
[units: years]
Mean (Standard Deviation)
  62.8  (16.0)     65.8  (14.3)     64.4  (15.2)  
Gender  
[units: participants]
     
Female     9     7     16  
Male     7     11     18  
Region of Enrollment  
[units: participants]
     
Korea, Republic of     16     18     34  



  Outcome Measures

1.  Primary:   Modified Barthel Index (MBI) Score at 6 Months   [ Time Frame: 6 months ]

2.  Secondary:   Chemical Laboratory Findings   [ Time Frame: 6 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

3.  Other Pre-specified:   Body Mass Index   [ Time Frame: 6 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

4.  Other Pre-specified:   Triceps Skin Fold Thickness   [ Time Frame: 6 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

5.  Other Pre-specified:   Subjective Global Assessment   [ Time Frame: 6 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Nam-Jong Paik
Organization: Seoul National University Bundang Hospital
phone: 82-031-787-7731
e-mail: njpaik@snu.ac.kr


Publications:

Responsible Party: Nam-Jong Paik, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier: NCT01810263     History of Changes
Other Study ID Numbers: B-1112-069-007
Study First Received: February 1, 2013
Results First Received: May 18, 2015
Last Updated: July 1, 2015
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)