The Efficacy of Intensive Nutritional Supplement in Patient With Stroke

Stroke Clinical Trial

Official title:

The Efficacy of Intensive Nutritional Supplement in Patient With Stroke: a Prospective Randomized Controlled Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01810263
• Other study ID #: B-1112-069-007
• Status: Terminated
• Phase: Phase 2/Phase 3
• First received: February 1, 2013
• Last updated: July 1, 2015
• Start date: May 2012
• Est. completion date: July 2014

Study information

• Verified date: July 2015
• Source: Seoul National University Bundang Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 34
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Malnutrition
• Stroke

Intervention

Dietary Supplement:
• high protein supplement
Dietary Supplement: high protein supplement

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam-si	Korea, Gyeonggi-do

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Bundang Hospital	Myongji Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (2)

Axelsson K, Asplund K, Norberg A, Alafuzoff I. Nutritional status in patients with acute stroke. Acta Med Scand. 1988;224(3):217-24. — View Citation

Gariballa SE, Parker SG, Taub N, Castleden M. Nutritional status of hospitalized acute stroke patients. Br J Nutr. 1998 Jun;79(6):481-7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Body Mass Index		6 months	No
Other	Triceps Skin Fold Thickness		6 months	No
Other	Subjective Global Assessment		6 months	No
Primary	Modified Barthel Index (MBI) Score at 6 Months	Scale range: 0-100 (higher values represent a better outcome)	6 months	No
Secondary	Chemical Laboratory Findings		6 months	No