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Clinical Trials/NCT02624752
NCT02624752
Completed
Not Applicable

Nutrition Supplementation in Hospitalized Patients (NutriSup Oral)

Lawson Health Research Institute1 site in 1 country63 target enrollmentOctober 5, 2016
ConditionsMalnutrition

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Malnutrition
Sponsor
Lawson Health Research Institute
Enrollment
63
Locations
1
Primary Endpoint
Hospital Readmission Rate
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

The purpose of this pilot study is to determine the effect of 3 months use of enhanced Oral Nutritional Supplement (ONS) on physical function and functional performance in malnourished elderly patients.

Detailed Description

The purpose of this pilot study is to determine the effect of 3 months use of enhanced Oral Nutritional Supplementation (ONS) on muscle accretion and functional performance in malnourished elderly patients. The objectives of this study are to determine feasibility of recruitment, adherence to intervention and retention of the sample, as well as the capacity of subjects to complete functional and muscle mass measures for a planned multi-centre Randomized Controlled Trial (RCT).

Registry
clinicaltrials.gov
Start Date
October 5, 2016
End Date
August 22, 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • admitted to a general medical ward and recruited within 48 hours
  • over the age of 65 years
  • malnourished (subjective global assessment categories B or C patients)

Exclusion Criteria

  • have an allergy or intolerance to any component of the oral supplement
  • are designated palliative care
  • are currently suffering from refeeding syndrome
  • have a pre-existing medical condition that prevents oral intake of full fluids,
  • have an expected length of stay of less than 48 hours from the time of assessment
  • have suspected ischemic stroke as cause for admission
  • reside in a residential care home
  • are unable to walk prior to current illness.
  • are pregnant/breastfeeding
  • have a current diagnosis of diabetic ketoacidosis or hyperglycemic hyperosmolar syndrome

Outcomes

Primary Outcomes

Hospital Readmission Rate

Time Frame: 90 days

The number of participants who are re-admitted to hospital within 90 days of randomization. This healthcare utilization outcome will be used to determine the cost-benefit of enhanced Oral Nutritional Supplementation.

Secondary Outcomes

  • Successful recruitment(1 year)
  • Adherence to treatment(90 days)

Study Sites (1)

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