The Efficacy of Intensive Nutritional Supplement in Patient With Stroke

This study has been terminated.
(No difference between the two groups)
Sponsor:
Collaborators:
Myongji University
DAESANG Corporation
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, 2014
Last verified: July 2014
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 Seoul National University Bundang Hospital:

Primary Outcome Measures:
  • Functional outcome measurements such as a Modified Barthel Index (MBI) [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Chemical laboratory findings [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Body Mass Index [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Triceps skin fold thickness [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Subjective global assessment [ Time Frame: 6 months ] [ Designated as safety issue: No ]

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
Other Name: Intensive Nutritional Supplement group
No Intervention: Control

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

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 1st onset stroke patient
  • 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 University
DAESANG Corporation
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
Study First Received: February 1, 2013
Last Updated: July 1, 2014
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by Seoul National University Bundang Hospital:
stroke
malnutrition
high protein

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

ClinicalTrials.gov processed this record on July 28, 2014