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The Efficacy of Intensive Nutritional Supplement in Patient With Stroke

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ClinicalTrials.gov Identifier: NCT01810263
Recruitment Status : Terminated (The study does not seem to provide benefits to patients.)
First Posted : March 13, 2013
Results First Posted : July 2, 2015
Last Update Posted : July 2, 2015
Sponsor:
Collaborator:
Myongji Hospital
Information provided by (Responsible Party):
Nam-Jong Paik, Seoul National University Bundang Hospital

Brief Summary:
The aim of this prospective randomized controlled study is to demonstrate the efficacy of Intensive Nutritional Supplement in Patient with Stroke.

Condition or disease Intervention/treatment Phase
Stroke Malnutrition Dietary Supplement: high protein supplement Phase 2 Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
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
Study Start Date : May 2012
Actual Primary Completion Date : July 2014
Actual Study Completion Date : July 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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 :
  1. Chemical Laboratory Findings [ Time Frame: 6 months ]

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


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Ages Eligible for Study:   Child, Adult, Older Adult
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

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

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 Posted: March 13, 2013    Key Record Dates
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