Liquid Nutritional Supplement on Malnutrition Hospitalized Patient

NCT ID: NCT04036825

Last Updated: 2019-08-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

138 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-31

Study Completion Date

2020-12-31

Brief Summary

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

Detailed Description

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Conditions

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Malnutrition

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Liquid Nutritional Supplement from Hospital Product

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

Group Type EXPERIMENTAL

Liquid Nutritional Supplement from Hospital Product

Intervention Type DIETARY_SUPPLEMENT

Liquid Nutritional Supplement from Hospital Product is given 2 times daily for 14 days

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Standard nutritional supplement is given 2 times daily as placebo for 14 days

Interventions

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Liquid Nutritional Supplement from Hospital Product

Liquid Nutritional Supplement from Hospital Product is given 2 times daily for 14 days

Intervention Type DIETARY_SUPPLEMENT

Placebo

Standard nutritional supplement is given 2 times daily as placebo for 14 days

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fakultas Kedokteran Universitas Indonesia

OTHER

Sponsor Role lead

Responsible Party

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Marcellus Simadibrata, Prof. PhD., SpPD, KGEH

Prof. dr. Marcellus Simadibrata, Ph.D., SpPD-KGEH

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Marcellus Simadibrata

Role: PRINCIPAL_INVESTIGATOR

Division Of Gastroenterology Department Of Internal Medicine Faculty Of Medicine Universitas Indonesia

Locations

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RSUPN dr. Cipto Mangunkusumo (Cipto Mangunkusumo Hospital)

Jakarta Pusat, , Indonesia

Site Status

Countries

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Indonesia

Central Contacts

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Marcellus Simadibrata

Role: CONTACT

0816920448

Facility Contacts

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Marcellus Simadibrata

Role: primary

0816920448

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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19-01-0082

Identifier Type: -

Identifier Source: org_study_id

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