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Liquid Nutritional Supplement on Malnutrition Hospitalized Patient

Primary Purpose

Malnutrition

Status
Unknown status
Phase
Not Applicable
Locations
Indonesia
Study Type
Interventional
Intervention
Liquid Nutritional Supplement from Hospital Product
Placebo
Sponsored by
Fakultas Kedokteran Universitas Indonesia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malnutrition focused on measuring Liquid Nutritional Supplement

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • RSUPN dr. Cipto Mangunkusumo (Cipto Mangunkusumo Hospital)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Liquid Nutritional Supplement from Hospital Product

Placebo

Arm Description

This 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

This group received standard liquid nutritional supplement as a placebo. Placebo will be given 2 times daily for 14 days

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change of Subjective Global Assessment (SGA) rank
SGA rank is classified to A (well nourished), B (moderately malnourished) and C (severely malnourished) and these option are chosen based on history and physical examination that are stated in the SGA form.
Change of body fat percentage
Body fat percentage is assessed by Bioelectrical Impedance Analysis (BIA)
Change of handgrip strength test score
Handgrip strength is assessed by handgrip strength score.
Change of hemoglobin level
Hemoglobin level is obtain from laboratory test
Change of prealbumin level
Prealbumin level is obtain from laboratory test
Change of Blood Urea Nitrogen (BUN) level
BUN level is obtain from laboratory test
Change of lipid profile level
Lipid profile level is obtain from laboratory test
Change of blood glucose level
Blood glucose level is obtain from laboratory test

Full Information

First Posted
July 25, 2019
Last Updated
August 1, 2019
Sponsor
Fakultas Kedokteran Universitas Indonesia
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1. Study Identification

Unique Protocol Identification Number
NCT04036825
Brief Title
Liquid Nutritional Supplement on Malnutrition Hospitalized Patient
Official Title
Effectivity of Liquid Nutritional Supplementation in Improving Nutritional Status of Hospitalized Malnutrition Patients: A Single-Blind Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Unknown status
Study Start Date
August 2019 (Anticipated)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fakultas Kedokteran Universitas Indonesia

4. Oversight

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

5. Study Description

Brief Summary
The aim of this study is to know the effectivity of liquid nutritional supplementation in malnutrition hospitalized patients

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malnutrition
Keywords
Liquid Nutritional Supplement

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
138 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Liquid Nutritional Supplement from Hospital Product
Arm Type
Experimental
Arm Description
This 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
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
This group received standard liquid nutritional supplement as a placebo. Placebo will be given 2 times daily for 14 days
Intervention Type
Dietary Supplement
Intervention Name(s)
Liquid Nutritional Supplement from Hospital Product
Intervention Description
Liquid Nutritional Supplement from Hospital Product is given 2 times daily for 14 days
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Standard nutritional supplement is given 2 times daily as placebo for 14 days
Primary Outcome Measure Information:
Title
Change of Body Mass Index (BMI)
Description
BMI was assessed from height and body calculation. Classification of BMI is based on World Health Organization (WHO) classification.
Time Frame
0 and 14 days
Secondary Outcome Measure Information:
Title
Change of Subjective Global Assessment (SGA) rank
Description
SGA rank is classified to A (well nourished), B (moderately malnourished) and C (severely malnourished) and these option are chosen based on history and physical examination that are stated in the SGA form.
Time Frame
0 and 14 days
Title
Change of body fat percentage
Description
Body fat percentage is assessed by Bioelectrical Impedance Analysis (BIA)
Time Frame
0 and 14 days
Title
Change of handgrip strength test score
Description
Handgrip strength is assessed by handgrip strength score.
Time Frame
0 and 14 days
Title
Change of hemoglobin level
Description
Hemoglobin level is obtain from laboratory test
Time Frame
0 and 14 days
Title
Change of prealbumin level
Description
Prealbumin level is obtain from laboratory test
Time Frame
0 and 14 days
Title
Change of Blood Urea Nitrogen (BUN) level
Description
BUN level is obtain from laboratory test
Time Frame
0 and 14 days
Title
Change of lipid profile level
Description
Lipid profile level is obtain from laboratory test
Time Frame
0 and 14 days
Title
Change of blood glucose level
Description
Blood glucose level is obtain from laboratory test
Time Frame
0 and 14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marcellus Simadibrata
Phone
0816920448
Email
marcellussimadibrata57@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marcellus Simadibrata
Organizational Affiliation
Division Of Gastroenterology Department Of Internal Medicine Faculty Of Medicine Universitas Indonesia
Official's Role
Principal Investigator
Facility Information:
Facility Name
RSUPN dr. Cipto Mangunkusumo (Cipto Mangunkusumo Hospital)
City
Jakarta Pusat
ZIP/Postal Code
10430
Country
Indonesia
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marcellus Simadibrata
Phone
0816920448
Email
marcellussimadibrata57@gmail.com

12. IPD Sharing Statement

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Liquid Nutritional Supplement on Malnutrition Hospitalized Patient

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