NCT03443557

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2006

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
10.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2016

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

February 18, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 23, 2018

Completed
Last Updated

March 13, 2018

Status Verified

March 1, 2018

Enrollment Period

10.9 years

First QC Date

February 18, 2018

Last Update Submit

March 10, 2018

Conditions

MalnourishedHospitalized

Keywords

Oral nutrition supplementmalnutritionmortality

Outcome Measures

Primary Outcomes (1)

  • 30-day mortality

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

    30 days

Secondary Outcomes (3)

  • Discharge rate

    30 days

  • Hospital length of stay

    30 days

  • Re-admission rate

    30 days

Other Outcomes (1)

  • prevalence of oral nutrition supplement prescription in Thai hospitalized patients

    10 years

Study Arms (2)

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

oral nutrition supplementOTHER

receiving prescription of oral nutrition supplement during hospitalization

oral nutrition supplement group

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Thai hospitalized patients

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rabin medical center

Petah Tikva, Israel

Location

Related 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;2009(2):CD003288. doi: 10.1002/14651858.CD003288.pub3.

    PMID: 19370584BACKGROUND

  • 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.

    PMID: 23448109BACKGROUND

  • 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.

    PMID: 17964008BACKGROUND

MeSH Terms

Conditions

Malnutrition

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Pierre Singer, Professor

    Rabin Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 18, 2018

First Posted

February 23, 2018

Study Start

January 1, 2006

Primary Completion

November 30, 2016

Study Completion

December 31, 2016

Last Updated

March 13, 2018

Record last verified: 2018-03

Locations

IL(1)