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CompletedNCT03443557Updated Mar 13, 2018

Effects of Oral Nutrition Supplement in Thai Malnourished Patients

An observational study in Malnourished and Hospitalized, sponsored by Pierre Singer. Completed at 1 site in Israel. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-03-13.

Sponsored by Pierre Singer · Observational

Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
500
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

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Conditions studied

  • Malnourished
  • Hospitalized

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Keywords

  • Oral nutrition supplement
  • malnutrition
  • mortality
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Non-probability sample

Study population

Thai hospitalized patients

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
500 participants (actual)
Patient registry
No

Groups and cohorts

  • oral nutrition supplement group

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

    Other: oral nutrition supplement

  • control group

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

Interventions

  • Otheroral nutrition supplement

    receiving prescription of oral nutrition supplement during hospitalization

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What researchers measure

Primary outcomes

  1. 30-day mortality

    dead rate at 30 days after study date will be extracted from hospital medical record by hospital staff

    Time frame: 30 days

Secondary outcomes

  1. Discharge rate

    Discharge status at 30 day will be extracted from hospital medical record by hospital staff

    Time frame: 30 days

  2. Hospital length of stay

    Hospital length of stay will be extracted from hospital medical record by hospital staff

    Time frame: 30 days

  3. Re-admission rate

    Re-admission rate will be extracted from hospital medical record by hospital staff

    Time frame: 30 days

Other outcomes

  1. prevalence of oral nutrition supplement prescription in Thai hospitalized patients

    prevalence of oral nutrition supplement prescription in Thai hospitalized patients

    Time frame: 10 years

06

Study locations

1 site
  • Rabin medical center
    Petah Tikva, Israel
07

References and documents

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. PubMed 19370584 ↗
  • 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. PubMed 23448109 ↗
  • 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. PubMed 17964008 ↗

Individual participant data

Plan to share: Undecided

08

Registry details

Key details

Study ID
NCT03443557
Lead sponsor
Pierre Singer
Responsible party
Pierre Singer (Professor, Rabin Medical Center) — Sponsor-investigator
First posted
Feb 23, 2018
Start date
Jan 1, 2006
Primary completion
Nov 30, 2016
Completion
Dec 31, 2016
Last update
Mar 13, 2018

Study contacts

Pierre Singer, Professor
principal investigator · Rabin Medical Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.

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