RecruitingNot ApplicableNCT07569003

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

Preliminary Study: Effect of Nutrition Therapy on Prealbumin and IGF-1 Level in Severe Malnutrition Under Five Years Old With Chronic Cholestasis


Sponsor

Indonesia University

Enrollment

15 participants

Start Date

Apr 6, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Max Age: 5 Years

Inclusion Criteria5

  • Children under 5 years old
  • Diagnosed with chronic cholestasis and severe malnutrition
  • Parental/guardian informed consent
  • Willingness to use a nasogastric tube (NGT) if indicated
  • Covered by national health insurance or other insurance

Exclusion Criteria7

  • Comorbidities (heart failure, chronic kidney disease, HIV)
  • Severe acute infections (acute gastroenteritis, dengue fever, pneumonia)
  • Post-liver transplant
  • Post-Kasai portoenterostomy (jaundice-free)
  • Currently exclusively breastfeeding
  • Use of steroids or NSAIDs within two weeks prior to the study.
  • Receiving a transfusion of whole blood, fresh frozen plasma, or platelets within one week prior to the study

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Interventions

OTHERNutrition 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.


Locations(1)

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

Jakarta Pusat, DKI Jakarta, Indonesia

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NCT07569003