Application and Effect Evaluation of Medium Chain Fatty Acid Rich Milk Powder in Infants With Cholestatic Liver Disease

Not Applicable

Withdrawn

• Conditions: Cholestatic Liver Disease
• Interventions: Dietary Supplement: Rich medium chain fatty acid milk powder group; Dietary Supplement: Regular milk powder group

• Registration Number: NCT05922332
• Lead Sponsor: Children's Hospital of Fudan University

Brief Summary

To verify the effect of feeding milk powder rich in medium chain fatty acids on improving the nutritional status and disease status of infants with cholestatic liver disease and To evaluate the safety of feeding milk powder rich in medium chain fatty acids in infants with cholestatic liver disease.

Detailed Description

This study will include all types of cholestatic liver disease in infants, randomized controlled study of the efficacy and safety of intervention with rich medium chain fatty acid milk powder,To verify the effect of feeding milk powder rich in medium chain fatty acids on improving the nutritional status and disease status of infants with cholestatic liver disease .

Study Timeline

• Study First Submitted: 2023-06-04
• Study First Submitted QC: 2023-06-26
• Study First Posted: 2023-06-28
• Study Start: 2025-03-01
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-17
• Last Update Posted: 2025-04-22
• Primary Completion: 2025-06
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

• meets the diagnostic criteria of cholestasis
• Artificial feeding (formula feeders)
• Age ≤6 months
• The course of cholestasis was > 1 month
• Informed consent of the guardian

Exclusion Criteria

• There are major non-cholestatic genetic diseases leading to nutritional intake disorders, such as gastrointestinal malformations
• Cholestasis with ascites and diarrhea
• In patients with oxidative impairment of medium chain fatty acids

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rich medium chain fatty acid milk powder group	Rich medium chain fatty acid milk powder group	This group will be fed milk powder rich in medium-chain fatty acids. The MCT content of formula milk is 39%, and the total energy is 68kcal/100ml.
Regular milk powder group	Regular milk powder group	This group will be fed regular milk powder.The MCT content of formula milk is less than 30%, and the total energy is 67kcal/100ml.

Primary Outcome Measures

Name	Time	Method
Z-scores of weight for age	"from enrollment to the 4 weekend(28 days)"	The change of WAZ would be calculation at the 4 weekend(28 days) after enrollment.

Trial Locations

Locations (1)

zhaoyang Gou; 🇨🇳 Shanghai, China