Ignite Creation Date:
2025-12-25 @ 3:53 AM
Ignite Modification Date:
2025-12-26 @ 2:43 AM
Study NCT ID:
NCT05670002
Status:
COMPLETED
Last Update Posted:
2025-03-12
First Post:
2022-12-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Nutrition Intervention of Complementary Milk Feeding to Improve Linear Growth of at Risk and Stunted Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 118}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-11-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2024-03-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-10', 'studyFirstSubmitDate': '2022-12-21', 'studyFirstSubmitQcDate': '2022-12-21', 'lastUpdatePostDateStruct': {'date': '2025-03-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Linear growth', 'timeFrame': '6 months', 'description': 'Change in LAZ/HAZ z-score from baseline to after 6 months of intervention'}], 'secondaryOutcomes': [{'measure': 'Growth velocity', 'timeFrame': '9 months', 'description': 'Compare growth velocity between 3 months pre- to first 3 months and 6 months post intervention'}, {'measure': 'Zinc Protoporphyrin (ZnPP) levels', 'timeFrame': '9 months', 'description': 'Any change in ZnPP levels pre and post intervention'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['At Risk or Stunted Children']}, 'descriptionModule': {'briefSummary': 'This is a non-randomized open label 6 months intervention study that aims to assess the effectiveness of consuming milk daily for 6 months will improve the linear growth rate of children aged 12-36 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '36 Months', 'minimumAge': '12 Months', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Malaysian child\n2. Boys and girls between the age of 12 and 36 months\n3. Length-for-age z score (LAZ) \\<-1.5 SD and \\> -3 SD according to the WHO Growth standard\n4. Weight-for-age z score WAZ \\<1.0 SD and \\> -3 SD\n5. Parents and/or legal guardian who can speak and read Malay or English language\n6. Written informed consent from parents and/or legal guardian\n7. Child who are apparently healthy with no obvious on-going infection and no history of chronic illness.\n8. Child with no physical and/or mental illness\n9. Parents and/or legal guardian who owns a mobile phone or smart phone\n10. Mothers who have ever received breastfeeding counselling from a qualified breastfeeding counsellor.\n\nExclusion Criteria:\n\n1. Child with zinc protoporphyrin (ZnPP) value of \\>65 (at either -T3 or T0)\n2. Clinical symptoms of iron deficiency as examined by Doctor even with zinc protoporphyrin (ZnPP) value between 40-64\n3. Child with severe acute malnutrition, other chronic diseases or any congenital disorder or deformity\n4. Child with an ongoing episode of diarrhoea or a history of persistent diarrhoea in the past month\n5. Child with history of cow's milk allergy/intolerance to milk\n6. Child who is already taking multivitamins, including iron, before enrolled to the study\n7. Child who is taking breastmilk as part of the diet"}, 'identificationModule': {'nctId': 'NCT05670002', 'briefTitle': 'Nutrition Intervention of Complementary Milk Feeding to Improve Linear Growth of at Risk and Stunted Children', 'organization': {'class': 'INDUSTRY', 'fullName': 'FrieslandCampina'}, 'officialTitle': 'Nutrition Intervention of Complementary Milk Feeding to Improve Linear Growth of at Risk and Stunted Children Aged Between 12-36 Months', 'orgStudyIdInfo': {'id': 'Moana'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Intervention', 'description': 'Taking milk supplement', 'interventionNames': ['Dietary Supplement: Milk supplement']}], 'interventions': [{'name': 'Milk supplement', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Children will take the milk supplement for a period of 6 months. During the intervention, anthropometry data, Zinc Protoporphyrin levels, dietary intake, any illness will be recorded.', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kubang Kerian', 'state': 'Kelantan', 'country': 'Malaysia', 'facility': 'School of Health Sciences', 'geoPoint': {'lat': 6.09123, 'lon': 102.27938}}], 'overallOfficials': [{'name': 'Hamid Jan Jan Mohamed', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universiti Sains Malaysia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'FrieslandCampina', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Universiti Sains Malaysia', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}