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Effects of Oral Nutrition Supplement in Thai Malnourished Patients

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ClinicalTrials.gov Identifier: NCT03443557
Recruitment Status : Completed
First Posted : February 23, 2018
Last Update Posted : March 13, 2018
Sponsor:
Information provided by (Responsible Party):
Pierre Singer, Rabin Medical Center

Brief 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.

Condition or disease Intervention/treatment
Malnourished Hospitalized 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.


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Study Type : Observational
Actual Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Effects of Oral Nutrition Supplement in Thai Malnourished Patients : A Cross-sectional Nutrition Day Survey
Actual Study Start Date : January 1, 2006
Actual Primary Completion Date : November 30, 2016
Actual Study Completion Date : December 31, 2016

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. 30-day mortality [ Time Frame: 30 days ]
    dead rate at 30 days after study date will be extracted from hospital medical record by hospital staff


Secondary Outcome Measures :
  1. Discharge rate [ Time Frame: 30 days ]
    Discharge status at 30 day will be extracted from hospital medical record by hospital staff

  2. Hospital length of stay [ Time Frame: 30 days ]
    Hospital length of stay will be extracted from hospital medical record by hospital staff

  3. Re-admission rate [ Time Frame: 30 days ]
    Re-admission rate will be extracted from hospital medical record by hospital staff


Other Outcome Measures:
  1. prevalence of oral nutrition supplement prescription in Thai hospitalized patients [ Time Frame: 10 years ]
    prevalence of oral nutrition supplement prescription in Thai hospitalized patients



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Thai hospitalized patients
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03443557


Locations
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Israel
Rabin medical center
Petah Tikva, Israel
Sponsors and Collaborators
Pierre Singer
Investigators
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Principal Investigator: Pierre Singer, Professor Rabin Medical Center

Publications:
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Responsible Party: Pierre Singer, Professor, Rabin Medical Center
ClinicalTrials.gov Identifier: NCT03443557     History of Changes
Other Study ID Numbers: 0829-17-RMC
First Posted: February 23, 2018    Key Record Dates
Last Update Posted: March 13, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Pierre Singer, Rabin Medical Center:
Oral nutrition supplement
malnutrition
mortality

Additional relevant MeSH terms:
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Malnutrition
Nutrition Disorders