Liquid Nutritional Supplement on Malnutrition Hospitalized Patient

Malnutrition Clinical Trial

Official title:

Effectivity of Liquid Nutritional Supplementation in Improving Nutritional Status of Hospitalized Malnutrition Patients: A Single-Blind Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04036825
• Other study ID #: 19-01-0082
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 2019
• Est. completion date: December 2020

Study information

• Verified date: August 2019
• Source: Fakultas Kedokteran Universitas Indonesia
• Contact: Marcellus Simadibrata
• Phone: 0816920448
• Email: marcellussimadibrata57[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 138
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Malnutrition

Intervention

Dietary Supplement:
• Liquid Nutritional Supplement from Hospital Product
Liquid Nutritional Supplement from Hospital Product is given 2 times daily for 14 days
• Placebo
Standard nutritional supplement is given 2 times daily as placebo for 14 days

Locations

Country	Name	City	State
Indonesia	RSUPN dr. Cipto Mangunkusumo (Cipto Mangunkusumo Hospital)	Jakarta Pusat

Sponsors (1)

Lead Sponsor	Collaborator
Fakultas Kedokteran Universitas Indonesia

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	0 and 14 days
Secondary	Change of body fat percentage	Body fat percentage is assessed by Bioelectrical Impedance Analysis (BIA)	0 and 14 days
Secondary	Change of handgrip strength test score	Handgrip strength is assessed by handgrip strength score.	0 and 14 days
Secondary	Change of hemoglobin level	Hemoglobin level is obtain from laboratory test	0 and 14 days
Secondary	Change of prealbumin level	Prealbumin level is obtain from laboratory test	0 and 14 days
Secondary	Change of Blood Urea Nitrogen (BUN) level	BUN level is obtain from laboratory test	0 and 14 days
Secondary	Change of lipid profile level	Lipid profile level is obtain from laboratory test	0 and 14 days
Secondary	Change of blood glucose level	Blood glucose level is obtain from laboratory test	0 and 14 days