Ignite Creation Date:
2025-12-24 @ 6:31 PM
Ignite Modification Date:
2026-02-26 @ 12:20 AM
Study NCT ID:
NCT03443557
Status:
COMPLETED
Last Update Posted:
2018-03-13
First Post:
2018-02-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Oral Nutrition Supplement in Thai Malnourished Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D044342', 'term': 'Malnutrition'}], 'ancestors': [{'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2016-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-03-10', 'studyFirstSubmitDate': '2018-02-18', 'studyFirstSubmitQcDate': '2018-02-18', 'lastUpdatePostDateStruct': {'date': '2018-03-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-02-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'prevalence of oral nutrition supplement prescription in Thai hospitalized patients', 'timeFrame': '10 years', 'description': 'prevalence of oral nutrition supplement prescription in Thai hospitalized patients'}], 'primaryOutcomes': [{'measure': '30-day mortality', 'timeFrame': '30 days', 'description': 'dead rate at 30 days after study date will be extracted from hospital medical record by hospital staff'}], 'secondaryOutcomes': [{'measure': 'Discharge rate', 'timeFrame': '30 days', 'description': 'Discharge status at 30 day will be extracted from hospital medical record by hospital staff'}, {'measure': 'Hospital length of stay', 'timeFrame': '30 days', 'description': 'Hospital length of stay will be extracted from hospital medical record by hospital staff'}, {'measure': 'Re-admission rate', 'timeFrame': '30 days', 'description': 'Re-admission rate will be extracted from hospital medical record by hospital staff'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Oral nutrition supplement', 'malnutrition', 'mortality'], 'conditions': ['Malnourished', 'Hospitalized']}, 'referencesModule': {'references': [{'pmid': '19370584', 'type': 'BACKGROUND', 'citation': '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': '23448109', 'type': 'BACKGROUND', '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.'}, {'pmid': '17964008', 'type': 'BACKGROUND', '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. doi: 10.1016/j.clnu.2007.08.011. Epub 2007 Oct 25.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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.\n\nDespite 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.\n\nThe 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Thai hospitalized patients', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 years old and above\n* identified as malnourished or at risk\n\nExclusion Criteria:\n\n* terminally ill patients\n* receiving concomitant enteral tube feeding and/or supplemental parenteral nutrition'}, 'identificationModule': {'nctId': 'NCT03443557', 'briefTitle': 'Effects of Oral Nutrition Supplement in Thai Malnourished Patients', 'organization': {'class': 'OTHER', 'fullName': 'Rabin Medical Center'}, 'officialTitle': 'Effects of Oral Nutrition Supplement in Thai Malnourished Patients : A Cross-sectional Nutrition Day Survey', 'orgStudyIdInfo': {'id': '0829-17-RMC'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'oral nutrition supplement group', 'description': 'hospitalized malnourished patients who were received oral nutrition supplement during hospital course', 'interventionNames': ['Other: oral nutrition supplement']}, {'label': 'control group', 'description': 'hospitalized malnourished patients who were received only hospital food during hospital course'}], 'interventions': [{'name': 'oral nutrition supplement', 'type': 'OTHER', 'description': 'receiving prescription of oral nutrition supplement during hospitalization', 'armGroupLabels': ['oral nutrition supplement group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Petah Tikva', 'country': 'Israel', 'facility': 'Rabin medical center', 'geoPoint': {'lat': 32.08707, 'lon': 34.88747}}], 'overallOfficials': [{'name': 'Pierre Singer, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rabin Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pierre Singer', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Pierre Singer', 'investigatorAffiliation': 'Rabin Medical Center'}}}}