Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-31 @ 11:06 AM
Study NCT ID:
NCT07324135
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-01-07
First Post:
2025-12-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Young Child Formula on Iron Status in Children 1-3 Years of Age.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000740', 'term': 'Anemia'}], 'ancestors': [{'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Prospective, randomized, double-blind, parallel-group, multi-centre intervention study'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 466}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2027-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-23', 'studyFirstSubmitDate': '2025-12-23', 'studyFirstSubmitQcDate': '2025-12-23', 'lastUpdatePostDateStruct': {'date': '2026-01-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Serum ferritin concentration', 'timeFrame': 'Baseline and 20 weeks post baseline'}], 'secondaryOutcomes': [{'measure': 'Daily iron intake', 'timeFrame': 'Baseline, 10 weeks and 20 weeks post-baseline'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['YCF', 'Young Child Formula', 'Anaemia', 'Iron status'], 'conditions': ['Iron Status']}, 'descriptionModule': {'briefSummary': 'This study evaluates the effect of young child formula in children 1-3 years of age. Subjects will receive either test or control product. Growth and health data, parent diaries and biological samples will be collected during the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '36 Months', 'minimumAge': '12 Months', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children aged 1 to 3 years\n* Healthy children (as per investigator clinical judgement and non-anaemic as confirmed by Hb levels) or meeting the criteria for mild anaemia based on Hb levels\n* Children familiar with drinking milk products (in combination with breastfeeding or not) for at least 3 weeks prior to screening.\n* Written informed consent provided by parent(s) / legally acceptable representative(s) aged ≥18 years at screening\n\nExclusion Criteria:\n\n* Low Hb meeting the criteria for moderate or severe anaemia\n* Use of iron and/or fibre supplementation within 3 months prior to screening\n* Any infection within 2 weeks prior to screening\n* Any other medical condition with known high CRP (\\>5 mg/L) / high AGP (\\>1 g/L) value within 2 weeks prior to screening\n* The use of medication that is likely to interfere with iron metabolism) within 2 weeks prior to screening\n* The use of medication to treat iron deficiency or anaemia within 3 months prior to screening\n* Any developmental delays that could impact feeding behaviour or growth, or any other condition that is likely to influence nutritional status or growth.\n* Disorders requiring a special diet.\n* Any other iron metabolism and related disorders\n* Children with known or suspected medical conditions requiring a special diet or special formulae, food allergy, or food intolerances.'}, 'identificationModule': {'nctId': 'NCT07324135', 'briefTitle': 'Effect of Young Child Formula on Iron Status in Children 1-3 Years of Age.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Nutricia Research'}, 'officialTitle': 'A Double-blind Randomized Controlled Study to Evaluate the Effect of Young Child Formula on Iron Status in Children 1-3 Years of Age.', 'orgStudyIdInfo': {'id': '24REX0077885'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Test product', 'description': 'Young Child Formula', 'interventionNames': ['Other: Nutritional product']}, {'type': 'OTHER', 'label': 'Control product', 'description': "Control: cow's milk", 'interventionNames': ['Other: Nutritional product']}], 'interventions': [{'name': 'Nutritional product', 'type': 'OTHER', 'description': 'parents will be instructed to provide subjects with 2-3 servings of Study Product per day', 'armGroupLabels': ['Control product', 'Test product']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Jakarta', 'country': 'Indonesia', 'contacts': [{'name': 'Principal Investigator', 'role': 'CONTACT'}], 'facility': 'Faculty of Medicine University of Indonesia', 'geoPoint': {'lat': -6.21462, 'lon': 106.84513}}], 'centralContacts': [{'name': 'Danone Global Research & Innovation Center (Nutricia Research)', 'role': 'CONTACT', 'email': 'register.clinicalresearchnutricia@danone.com', 'phone': '+31 30 2095 000'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nutricia Research', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}