Back to resultsOral Nutrition Supplementation in Hospitalized Patients (NutriSup Oral)
Primary Purpose
Malnutrition
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Ensure
Sponsored by
About this trial
This is an interventional treatment trial for Malnutrition focused on measuring Oral Nutrition Supplementation
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
Sites / Locations
- LHSC-University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Standard of Care
Ensure
Arm Description
Standard of care could include liberalized diet consisting of 3 meals and snacks served daily or the standard oral nutrition supplementation (ONS) routinely used in the hospital, as prescribed by the medical team.These routine meals and snacks are the "standard of care."
Patients randomized to Enhanced Oral Nutritional Supplementation (ONS) will receive the standard of care hospital menu (3 meals and snacks per day) plus 2 cans of Ensure (or similar product) per day while in hospital and will continue 2 cans per day of Ensure when discharged home until they have been receiving the enhanced ONS for a total of 90 days.
Outcomes
Primary Outcome Measures
Hospital Readmission Rate
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 Outcome Measures
Successful recruitment
We will view this pilot study as demonstrating feasibility of recruitment if we are able to recruit 60 patients over twelve months (approximately 5 patients per month for the overall study).
Adherence to treatment
Adherence to the study treatments will be defined as ≥85% of patients were given the allocated intervention. Preliminary estimates of non-administration of the trial intervention are needed, along with strategies that maximize exposure to the intervention.
Full Information
NCT ID
NCT02624752
First Posted
December 4, 2015
Last Updated
March 13, 2019
Sponsor
Lawson Health Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT02624752
Brief Title
Oral Nutrition Supplementation in Hospitalized Patients
Acronym
NutriSup Oral
Official Title
Nutrition Supplementation in Hospitalized Patients (NutriSup Oral)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
October 5, 2016 (Actual)
Primary Completion Date
August 22, 2018 (Actual)
Study Completion Date
August 22, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lawson Health Research Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malnutrition
Keywords
Oral Nutrition Supplementation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Patients will be randomized via REDCap (Research Electronic Data Capture), a secure, centralized web-based randomization module to:
Ensure Enlive (enhanced ONS) + standard menu; or
Standard of care (including standard menu and possibly ONS) Patients randomized will receive standard menu or standard menu plus enhanced oral nutritional supplements (ONS). Patients randomized to enhanced ONS, will receive one bottle of ONS Abbott Ensure Enlive (235 mL, 350 calories), or similar product, two times daily for 90 days.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
63 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard of Care
Arm Type
No Intervention
Arm Description
Standard of care could include liberalized diet consisting of 3 meals and snacks served daily or the standard oral nutrition supplementation (ONS) routinely used in the hospital, as prescribed by the medical team.These routine meals and snacks are the "standard of care."
Arm Title
Ensure
Arm Type
Experimental
Arm Description
Patients randomized to Enhanced Oral Nutritional Supplementation (ONS) will receive the standard of care hospital menu (3 meals and snacks per day) plus 2 cans of Ensure (or similar product) per day while in hospital and will continue 2 cans per day of Ensure when discharged home until they have been receiving the enhanced ONS for a total of 90 days.
Intervention Type
Dietary Supplement
Intervention Name(s)
Ensure
Intervention Description
Comparison of enhanced oral nutrition supplementation versus standard of care
Primary Outcome Measure Information:
Title
Hospital Readmission Rate
Description
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.
Time Frame
90 days
Secondary Outcome Measure Information:
Title
Successful recruitment
Description
We will view this pilot study as demonstrating feasibility of recruitment if we are able to recruit 60 patients over twelve months (approximately 5 patients per month for the overall study).
Time Frame
1 year
Title
Adherence to treatment
Description
Adherence to the study treatments will be defined as ≥85% of patients were given the allocated intervention. Preliminary estimates of non-administration of the trial intervention are needed, along with strategies that maximize exposure to the intervention.
Time Frame
90 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adam Rahman, MD, FRCPC
Organizational Affiliation
St.Joseph's Health Care, London ON
Official's Role
Principal Investigator
Facility Information:
Facility Name
LHSC-University Hospital
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5A5
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
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Oral Nutrition Supplementation in Hospitalized Patients
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