Effects of Oral Nutrition Supplement in Thai Malnourished Patients

Malnourished Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03443557
• Other study ID #: 0829-17-RMC
• Status: Completed
• Phase: N/A
• First received: February 18, 2018
• Last updated: March 10, 2018
• Start date: January 1, 2006
• Est. completion date: December 31, 2016

Study information

• Verified date: March 2018
• Source: Rabin Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: December 31, 2016
• Est. primary completion date: November 30, 2016
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hospitalized
• Malnourished
• Malnutrition

Intervention

Other:
• oral nutrition supplement
receiving prescription of oral nutrition supplement during hospitalization

Locations

Country	Name	City	State
Israel	Rabin medical center	Petah Tikva

Sponsors (1)

Lead Sponsor	Collaborator
Pierre Singer

Country where clinical trial is conducted

Israel, 

References & Publications (3)

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;(2):CD003288. doi: 10.1002/14651858.CD003288.pub3. Review. — View Citation

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. Epub 2007 Oct 25. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	prevalence of oral nutrition supplement prescription in Thai hospitalized patients	prevalence of oral nutrition supplement prescription in Thai hospitalized patients	10 years
Primary	30-day mortality	dead rate at 30 days after study date will be extracted from hospital medical record by hospital staff	30 days
Secondary	Discharge rate	Discharge status at 30 day will be extracted from hospital medical record by hospital staff	30 days
Secondary	Hospital length of stay	Hospital length of stay will be extracted from hospital medical record by hospital staff	30 days
Secondary	Re-admission rate	Re-admission rate will be extracted from hospital medical record by hospital staff	30 days