The Efficacy of Intensive Nutritional Supplement in Patient With Stroke

Terminated

Phase 2/3 Results

Trial Description

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

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.

Trial Stopped: The study does not seem to provide benefits to patients.

Conditions

Interventions

  • High protein supplement Dietary Supplement
    Other Names: Intensive Nutritional Supplement group
    Intervention Desc: Dietary Supplement: high protein supplement
    ARM 1: Kind: Experimental
    Label: high protein supplement
    Description: high protein supplement given

Trial Design

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

Outcomes

Type Measure Time Frame Safety Issue
Primary Functional outcome measurements such as a Modified Barthel Index (MBI) 6 months No
Secondary Chemical laboratory findings 6 months No
Primary Modified Barthel Index (MBI) Score at 6 Months 6 months No

Sponsors