Prealbumin and IGF-1 Levels in Pediatric Chronic Cholestasis With Severe Malnutrition After Nutrition Therapy
Recruiting now · Not applicable
Conditions studied: Chronic Cholestasis, Severe Malnutrition, Pediatric Cholestasis
In brief
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.
Key facts
- Study ID
- NCT07569003
- Run by
- Indonesia University
- People needed
- 15
- Starts
- 2026-04-06
- Expected to finish
- 2026-07-01
- Last updated by the study team
- 2026-05-06
Who can join
Age: any, up to 5. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Faculty of Medicine, University of Indonesia, Jakarta, DKI Jakarta 10430 — Jakarta Pusat, DKI Jakarta, Indonesia (enrolling)
Full record on ClinicalTrials.gov
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