Effects of Oral Nutrition Supplement in Thai Malnourished Patients

Effects of Oral Nutrition Supplement in Thai Malnourished Patients : A Cross-sectional Nutrition Day Survey

A retrospective study based on Thai data from Nutrition Day study (nD). Comparing clinical outcome between malnourished patients who were prescribed oral nutrition supplement along with hospital diet and those without oral nutrition supplement.

Study Overview

• Status: Completed
• Conditions: Malnourished; Hospitalized
• Intervention / Treatment: Other: oral nutrition supplement

Detailed Description

Prevalence of malnutrition in hospitalized patients varies from 30-70% depend on category of patients recruited. Adverse effects of malnutrition include increase of infection complication, increase hospital length of stay, and increase mortality. Prescription of oral nutrition supplement (ONS) have been proved to provide patients more calorie and protein intake and can improve patients' outcome.

Despite the proved benefits of oral nutrition supplement(ONS), prescription of it in Thai hospitalized patients are far less than it should. The main reason of this under-practice is the limitation of health policies which considered ONS as an optional from main meals. Additional cost for ONS has to be paid by patients themselves, therefore the patients who have no willing to pay usually refuse to receive ONS. Unawareness of physician regarding its benefits is also a problem. In order to convince Thai authorities to allow for reimbursement of ONS and encourage prescription of ONS among physicians, an evidence based benefits of ONS in large Thai population is needed.

The nD study was a single-day, population-based, standardized, multinational, cross-sectional audit and was performed worldwide, includes Thailand, in hospitals, nursing homes and intensive care units performing since 2006 to present. Every year, registered hospitals survey their patients regarding nutritional status, nutritional support. A follow-up for clinical outcome are perform at 30 days after the first survey, include mortality, readmission. This study will based on data of Thai patients collected from nD study during 2006-2016.

• Study Type: Observational
• Enrollment (Actual): 500

Contacts and Locations

Study Locations

• Israel
  • Petah Tikva, Israel
    • Rabin Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Thai hospitalized patients

Description

Inclusion Criteria:

• Age 18 years old and above
• identified as malnourished or at risk

Exclusion Criteria:

• terminally ill patients
• receiving concomitant enteral tube feeding and/or supplemental parenteral nutrition

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
oral nutrition supplement group; hospitalized malnourished patients who were received oral nutrition supplement during hospital course	Other: oral nutrition supplement; receiving prescription of oral nutrition supplement during hospitalization
control group; hospitalized malnourished patients who were received only hospital food during hospital course

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
30-day mortality	dead rate at 30 days after study date will be extracted from hospital medical record by hospital staff	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Discharge rate	Discharge status at 30 day will be extracted from hospital medical record by hospital staff	30 days
Hospital length of stay	Hospital length of stay will be extracted from hospital medical record by hospital staff	30 days
Re-admission rate	Re-admission rate will be extracted from hospital medical record by hospital staff	30 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
prevalence of oral nutrition supplement prescription in Thai hospitalized patients	prevalence of oral nutrition supplement prescription in Thai hospitalized patients	10 years

Collaborators and Investigators

• Sponsor: Pierre Singer
• Investigators: Principal Investigator: Pierre Singer, Professor, Rabin Medical Center

Publications and helpful links

General Publications

• Milne AC, Potter J, Vivanti A, Avenell A. Protein and energy supplementation in elderly people at risk from malnutrition. Cochrane Database Syst Rev. 2009 Apr 15;2009(2):CD003288. doi: 10.1002/14651858.CD003288.pub3.
• Philipson TJ, Snider JT, Lakdawalla DN, Stryckman B, Goldman DP. Impact of oral nutritional supplementation on hospital outcomes. Am J Manag Care. 2013 Feb;19(2):121-8.
• Norman K, Kirchner H, Freudenreich M, Ockenga J, Lochs H, Pirlich M. Three month intervention with protein and energy rich supplements improve muscle function and quality of life in malnourished patients with non-neoplastic gastrointestinal disease--a randomized controlled trial. Clin Nutr. 2008 Feb;27(1):48-56. doi: 10.1016/j.clnu.2007.08.011. Epub 2007 Oct 25.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2006
• Primary Completion (Actual): November 30, 2016
• Study Completion (Actual): December 31, 2016

Study Registration Dates

• First Submitted: February 18, 2018
• First Submitted That Met QC Criteria: February 18, 2018
• First Posted (Actual): February 23, 2018

Study Record Updates

• Last Update Posted (Actual): March 13, 2018
• Last Update Submitted That Met QC Criteria: March 10, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Keywords: mortality; malnutrition; Oral nutrition supplement
• Additional Relevant MeSH Terms: Nutrition Disorders; Malnutrition
• Other Study ID Numbers: 0829-17-RMC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No