Liquid Nutritional Supplement on Malnutrition Hospitalized Patient
Effectivity of Liquid Nutritional Supplementation in Improving Nutritional Status of Hospitalized Malnutrition Patients: A Single-Blind Randomized Controlled Trial
1 other identifier
interventional
138
1 country
1
Brief Summary
The aim of this study is to know the effectivity of liquid nutritional supplementation in malnutrition hospitalized patients
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 25, 2019
CompletedFirst Posted
Study publicly available on registry
July 30, 2019
CompletedStudy Start
First participant enrolled
August 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2020
CompletedAugust 5, 2019
August 1, 2019
1.3 years
July 25, 2019
August 1, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change of Body Mass Index (BMI)
BMI was assessed from height and body calculation. Classification of BMI is based on World Health Organization (WHO) classification.
0 and 14 days
Secondary Outcomes (8)
Change of Subjective Global Assessment (SGA) rank
0 and 14 days
Change of body fat percentage
0 and 14 days
Change of handgrip strength test score
0 and 14 days
Change of hemoglobin level
0 and 14 days
Change of prealbumin level
0 and 14 days
- +3 more secondary outcomes
Study Arms (2)
Liquid Nutritional Supplement from Hospital Product
EXPERIMENTALThis group received liquid nutritional supplement from hospital product. The product is in a form of low lactose milk ready to drink with volume 200 ml and will be given 2 times daily for 14 days. This product is consist of 1.017 kcal/ml, 10 vitamin and 9 mineral
Placebo
PLACEBO COMPARATORThis group received standard liquid nutritional supplement as a placebo. Placebo will be given 2 times daily for 14 days
Interventions
Liquid Nutritional Supplement from Hospital Product is given 2 times daily for 14 days
Standard nutritional supplement is given 2 times daily as placebo for 14 days
Eligibility Criteria
You may qualify if:
- aged ≥ 18 years old to 60 years old
- malnutrition hospitalized patient based on European Society for Clinical Nutrition and Metabolism (ESPEN) 2015 criteria
- agreed to participate
You may not qualify if:
- malignancy
- chronic kidney disease stage III-V
- decompensated hepatic cirrhosis
- allergic to milk or lactose intolerance
- could not be randomised and participate in this study by clinical judgement
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
RSUPN dr. Cipto Mangunkusumo (Cipto Mangunkusumo Hospital)
Jakarta Pusat, 10430, Indonesia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marcellus Simadibrata
Division Of Gastroenterology Department Of Internal Medicine Faculty Of Medicine Universitas Indonesia
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof. dr. Marcellus Simadibrata, Ph.D., SpPD-KGEH
Study Record Dates
First Submitted
July 25, 2019
First Posted
July 30, 2019
Study Start
August 1, 2019
Primary Completion
December 1, 2020
Study Completion
December 1, 2020
Last Updated
August 5, 2019
Record last verified: 2019-08