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

February 1, 2013
July 1, 2015
May 2012
July 2014   (final data collection date for primary outcome measure)
Modified Barthel Index (MBI) Score at 6 Months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Scale range: 0-100 (higher values represent a better outcome)
Functional outcome measurements such as a Modified Barthel Index (MBI) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01810263 on ClinicalTrials.gov Archive Site
Chemical Laboratory Findings [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
  • 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 ]
Same as current
 
The Efficacy of Intensive Nutritional Supplement in Patient With Stroke
The Efficacy of Intensive Nutritional Supplement in Patient With Stroke: a Prospective Randomized Controlled Trial

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

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.

Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
  • Stroke
  • Malnutrition
Dietary Supplement: high protein supplement
Dietary Supplement: high protein supplement
Other Name: Intensive Nutritional Supplement group
  • Experimental: high protein supplement
    high protein supplement given
    Intervention: Dietary Supplement: high protein supplement
  • No Intervention: Control
    no intervention

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
34
July 2014
July 2014   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01810263
B-1112-069-007
Yes
Nam-Jong Paik, Seoul National University Bundang Hospital
Seoul National University Bundang Hospital
Myongji Hospital
Principal Investigator: Nam-Jong Paik, MD, PhD Department of Rehabilitation Medicine, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Seongnam, Korea
Seoul National University Bundang Hospital
July 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP