Oral Nutrition Supplementation in Hospitalized Patients

Malnutrition Clinical Trial

— NutriSup Oral  

Official title:

Nutrition Supplementation in Hospitalized Patients (NutriSup Oral)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02624752
• Other study ID #: SIG2014F-08B
• Status: Completed
• Phase: N/A
• Start date: October 5, 2016
• Est. completion date: August 22, 2018

Study information

• Verified date: March 2019
• Source: Lawson Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: August 22, 2018
• Est. primary completion date: August 22, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Malnutrition

Intervention

Dietary Supplement:
• Ensure
Comparison of enhanced oral nutrition supplementation versus standard of care

Locations

Country	Name	City	State
Canada	LHSC-University Hospital	London	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Lawson Health Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	90 days
Secondary	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).	1 year
Secondary	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.	90 days