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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:
ClinicalTrials.gov Identifier:
NCT01810263
First Posted: March 13, 2013
Last Update Posted: July 2, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Myongji Hospital
Information provided by (Responsible Party):
Nam-Jong Paik, Seoul National University Bundang Hospital
  Purpose
The aim of this prospective randomized controlled study is to demonstrate the efficacy of Intensive Nutritional Supplement in Patient with Stroke.

Condition Intervention Phase
Stroke Malnutrition Dietary Supplement: high protein supplement Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Efficacy of Intensive Nutritional Supplement in Patient With Stroke: a Prospective Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Nam-Jong Paik, Seoul National University Bundang Hospital:

Primary Outcome Measures:
  • Modified Barthel Index (MBI) Score at 6 Months [ Time Frame: 6 months ]
    Scale range: 0-100 (higher values represent a better outcome)


Secondary Outcome Measures:
  • Chemical Laboratory Findings [ Time Frame: 6 months ]

Other Outcome Measures:
  • Body Mass Index [ Time Frame: 6 months ]
  • Triceps Skin Fold Thickness [ Time Frame: 6 months ]
  • Subjective Global Assessment [ Time Frame: 6 months ]

Enrollment: 34
Study Start Date: May 2012
Study Completion Date: July 2014
Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: high protein supplement
high protein supplement given
Dietary Supplement: high protein supplement
Dietary Supplement: high protein supplement
Other Name: Intensive Nutritional Supplement group
No Intervention: Control
no intervention

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01810263


Locations
Korea, Republic of
Seoul National University Bundang Hospital
Seongnam-si, Korea, Gyeonggi-do, Korea, Republic of, 463-707
Sponsors and Collaborators
Seoul National University Bundang Hospital
Myongji Hospital
Investigators
Principal Investigator: Nam-Jong Paik, MD, PhD Department of Rehabilitation Medicine, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Seongnam, Korea
  More Information

Publications:
Responsible Party: Nam-Jong Paik, professor, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier: NCT01810263     History of Changes
Other Study ID Numbers: B-1112-069-007
First Submitted: February 1, 2013
First Posted: March 13, 2013
Results First Submitted: May 18, 2015
Results First Posted: July 2, 2015
Last Update Posted: July 2, 2015
Last Verified: July 2015

Keywords provided by Nam-Jong Paik, Seoul National University Bundang Hospital:
stroke
malnutrition
high protein

Additional relevant MeSH terms:
Stroke
Malnutrition
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Nutrition Disorders