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

NCT07569003 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2026-05-06

No results posted yet for this study

Summary

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

  • Chronic Cholestasis
  • Severe Malnutrition
  • Pediatric Cholestasis

Interventions

OTHER

Nutrition Therapy

The nutritional therapy provided consists of a liquid formula with BPOM approval number MD 250976001600096 for subjects under 1 year of age, and BPOM approval number ML 562409102696 for subjects over 1 year of age. Patients are also given micronutrients in the form of vitamins A, D, E, and K, as well as vitamin B1, folic acid, and zinc as needed.

Sponsors & Collaborators

  • Indonesia University

    lead OTHER

Principal Investigators

  • Tri Faranita, dr, Sp.A · Department of Child Health, Faculty of Medicine, University of Indonesia - Cipto Mangunkusumo Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
5 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-06
Primary Completion
2026-06-30
Completion
2026-07-31

Countries

  • Indonesia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07569003 on ClinicalTrials.gov