Effects of Oral Nutrition Supplement in Thai Malnourished Patients

NCT ID: NCT03443557

Last Updated: 2018-03-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-01-01

Study Completion Date

2016-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Malnourished Hospitalized

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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oral nutrition supplement group

hospitalized malnourished patients who were received oral nutrition supplement during hospital course

oral nutrition supplement

Intervention Type OTHER

receiving prescription of oral nutrition supplement during hospitalization

control group

hospitalized malnourished patients who were received only hospital food during hospital course

No interventions assigned to this group

Interventions

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oral nutrition supplement

receiving prescription of oral nutrition supplement during hospitalization

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pierre Singer

OTHER

Sponsor Role lead

Responsible Party

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Pierre Singer

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Pierre Singer, Professor

Role: PRINCIPAL_INVESTIGATOR

Rabin Medical Center

Locations

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Rabin medical center

Petah Tikva, , Israel

Site Status

Countries

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Israel

References

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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.

Reference Type BACKGROUND
PMID: 19370584 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23448109 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17964008 (View on PubMed)

Other Identifiers

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0829-17-RMC

Identifier Type: -

Identifier Source: org_study_id

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