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

Primary Purpose

Cholestatic Liver Disease

Status

Not yet recruiting

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Rich medium chain fatty acid milk powder group

Regular milk powder group

About this trial

This is an interventional treatment trial for Cholestatic Liver Disease

Eligibility Criteria

1 Month - 6 Months (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

zhaoyang Gou

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Rich medium chain fatty acid milk powder group

Regular milk powder group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Z-scores of weight for age

The change of WAZ would be calculation at the 4 weekend(28 days) after enrollment.

Secondary Outcome Measures

Full Information

NCT ID

NCT05922332

First Posted

June 4, 2023

Last Updated

September 4, 2023

Sponsor

Children's Hospital of Fudan University

1. Study Identification

Unique Protocol Identification Number

NCT05922332

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Not yet recruiting

Study Start Date

October 2023 (Anticipated)

Primary Completion Date

June 2025 (Anticipated)

Study Completion Date

June 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Children's Hospital of Fudan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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 .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cholestatic Liver Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

64 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Rich medium chain fatty acid milk powder group

Arm Type

Experimental

Arm Description

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.

Arm Title

Regular milk powder group

Arm Type

Active Comparator

Arm Description

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.

Intervention Type

Dietary Supplement

Intervention Name(s)

Rich medium chain fatty acid milk powder group

Intervention Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

Regular milk powder group

Intervention Description

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

Primary Outcome Measure Information:

Title

Z-scores of weight for age

Description

The change of WAZ would be calculation at the 4 weekend(28 days) after enrollment.

Time Frame

"from enrollment to the 4 weekend(28 days)"

10. Eligibility

Sex

All

Minimum Age & Unit of Time

1 Month

Maximum Age & Unit of Time

6 Months

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

zhaoyang Gou zhaoyang Gou

Phone

18702113705

zy18702113705@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Children's Hospital of Fudan University Children's Hospital of Fudan University

Organizational Affiliation

employee

Official's Role

Study Chair

Facility Information:

Facility Name

zhaoyang Gou

City

Shanghai

Country

China

Facility Contact:

First Name & Middle Initial & Last Name & Degree

zhaoyang Gou

Phone

18702113705

zy18702113705@163.com

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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