Study Stopped
The study could not be conducted as a randomized controlled study due to a change in the protocol, and the study needs to be stopped.
Application and Effect Evaluation of Medium Chain Fatty Acid Rich Milk Powder in Infants With Cholestatic Liver Disease
1 other identifier
interventional
N/A
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Apr 2025
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 4, 2023
CompletedFirst Posted
Study publicly available on registry
June 28, 2023
CompletedStudy Start
First participant enrolled
April 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2025
CompletedSeptember 15, 2025
September 1, 2025
9 months
June 4, 2023
September 9, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Z-scores of weight for age
The change of WAZ would be calculation at the 4 weekend(28 days) after enrollment.
"from enrollment to the 4 weekend(28 days)"
Study Arms (2)
Rich medium chain fatty acid milk powder group
EXPERIMENTALThis 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
ACTIVE COMPARATORThis group will be fed regular milk powder.The MCT content of formula milk is less than 30%, and the total energy is 67kcal/100ml.
Interventions
In intervention group,there are 32 infants.They will be fed with rich medium chain fatty acid milk powder, formula with MCT content of 39%, total energy of 68kcal/100ml, and feeding frequency at a 3-hour interval
In control group,there are 32 infants.They will be fed regular milk powder,formula with MCT content of less than 30%, total energy of 67kcal/100ml, and feeding frequency at a 3 hours interval
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
zhaoyang Gou
Shanghai, China
Study Officials
- STUDY CHAIR
Children's Hospital of Fudan University Children's Hospital of Fudan University
employee
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 4, 2023
First Posted
June 28, 2023
Study Start
April 1, 2025
Primary Completion
December 30, 2025
Study Completion
December 30, 2025
Last Updated
September 15, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will not share