Ignite Creation Date:
2025-12-24 @ 9:32 PM
Ignite Modification Date:
2026-01-03 @ 4:34 AM
Study NCT ID:
NCT05922332
Status:
WITHDRAWN
Last Update Posted:
2025-09-15
First Post:
2023-06-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Application and Effect Evaluation of Medium Chain Fatty Acid Rich Milk Powder in Infants With Cholestatic Liver Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': '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a randomized controlled study due to a change in the protocol, and the study needs to be stopped.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2025-04-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2025-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-09', 'studyFirstSubmitDate': '2023-06-04', 'studyFirstSubmitQcDate': '2023-06-26', 'lastUpdatePostDateStruct': {'date': '2025-09-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-06-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Z-scores of weight for age', 'timeFrame': '"from enrollment to the 4 weekend(28 days)"', 'description': 'The change of WAZ would be calculation at the 4 weekend(28 days) after enrollment.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cholestatic Liver Disease']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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 .'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Months', 'minimumAge': '1 Month', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* meets the diagnostic criteria of cholestasis\n* Artificial feeding (formula feeders)\n* Age ≤6 months\n* The course of cholestasis was \\> 1 month\n* Informed consent of the guardian\n\nExclusion Criteria:\n\n* There are major non-cholestatic genetic diseases leading to nutritional intake disorders, such as gastrointestinal malformations\n* Cholestasis with ascites and diarrhea\n* In patients with oxidative impairment of medium chain fatty acids'}, 'identificationModule': {'nctId': 'NCT05922332', 'briefTitle': 'Application and Effect Evaluation of Medium Chain Fatty Acid Rich Milk Powder in Infants With Cholestatic Liver Disease', 'organization': {'class': 'OTHER', 'fullName': "Children's Hospital of Fudan University"}, 'officialTitle': 'Application and Effect Evaluation of Medium Chain Fatty Acid Rich Milk Powder in Infants With Cholestatic Liver Disease', 'orgStudyIdInfo': {'id': 'CHFudanU0530'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Rich medium chain fatty acid milk powder group', '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.', 'interventionNames': ['Dietary Supplement: Rich medium chain fatty acid milk powder group']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Regular milk powder group', '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.', 'interventionNames': ['Dietary Supplement: Regular milk powder group']}], 'interventions': [{'name': 'Rich medium chain fatty acid milk powder group', 'type': 'DIETARY_SUPPLEMENT', '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', 'armGroupLabels': ['Rich medium chain fatty acid milk powder group']}, {'name': 'Regular milk powder group', 'type': 'DIETARY_SUPPLEMENT', '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', 'armGroupLabels': ['Regular milk powder group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Shanghai', 'country': 'China', 'facility': 'zhaoyang Gou', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': "Children's Hospital of Fudan University Children's Hospital of Fudan University", 'role': 'STUDY_CHAIR', 'affiliation': 'employee'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Hospital of Fudan University", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}