Actively Recruiting

Phase Not Applicable
Age: 0 - 5Years
All Genders
NCT07569003

Prealbumin and IGF-1 Levels in Pediatric Chronic Cholestasis With Severe Malnutrition After Nutrition Therapy

Led by Indonesia University · Updated on 2026-05-06

15

Participants Needed

1

Research Sites

12 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The goal of this clinical trial is to learn if a high-energy liquid diet improves the nutritional status of children with chronic cholestasis (a liver condition that blocks bile flow). Researchers want to see if this diet helps children who are malnourished. The main questions the study aims to answer are: * Does the liquid diet raise the level of prealbumin (a marker of nutrition) in the blood? * Does the liquid diet raise the level of Insulin-like Growth Factor-1 (IGF-1) (a hormone that helps growth) in the blood? Participants will: * Consume a high-energy liquid diet for 14 days. * Give blood samples at the start and at the end of the 2-week study. * Keep a daily record of what they eat and drink in a food diary. Researchers will compare the blood test results from the start and the end of the study to see if the liquid diet works to improve the children's prealbumin and IGF-1 levels. This study is important to help children with liver problems grow better and stay healthy.

CONDITIONS

Official Title

Prealbumin and IGF-1 Levels in Pediatric Chronic Cholestasis With Severe Malnutrition After Nutrition Therapy

Who Can Participate

Age: 0 - 5Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Children under 5 years old
  • Diagnosed with chronic cholestasis and severe malnutrition
  • Parental or guardian informed consent
  • Willingness to use a nasogastric tube if needed
  • Covered by national health insurance or other insurance
Not Eligible

You will not qualify if you...

  • Presence of comorbidities such as heart failure, chronic kidney disease, or HIV
  • Severe acute infections including acute gastroenteritis, dengue fever, or pneumonia
  • History of liver transplant
  • History of Kasai portoenterostomy with jaundice-free status
  • Currently exclusively breastfeeding
  • Use of steroids or NSAIDs within two weeks before the study
  • Receiving transfusion of whole blood, fresh frozen plasma, or platelets within one week before the study

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Faculty of Medicine, University of Indonesia, Jakarta, DKI Jakarta 10430

Jakarta Pusat, DKI Jakarta, Indonesia, 10430

Actively Recruiting

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Research Team

T

Tri Faranita, dr, Sp.A

CONTACT

K

Klara Yuliarti, Dr. dr, Sp.A(K)

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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