Ignite Creation Date:
2025-12-25 @ 12:11 AM
Ignite Modification Date:
2025-12-25 @ 10:11 PM
Study NCT ID:
NCT06318858
Status:
RECRUITING
Last Update Posted:
2024-04-05
First Post:
2024-03-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Daily and Weekly Iron Supplementation in Infants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000740', 'term': 'Anemia'}], 'ancestors': [{'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007505', 'term': 'Iron-Dextran Complex'}], 'ancestors': [{'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D003911', 'term': 'Dextrans'}, {'id': 'D005936', 'term': 'Glucans'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR'], 'maskingDescription': 'Letter codes were assigned to the iron syrup and the placebo by researchers who have not involved in the study. The codes have been kept until data analysis and report writing are complete.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'group 1: daily iron syrup supplementation group 2: weekly iron syrup supplementation'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-03-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2024-10-14', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-04', 'studyFirstSubmitDate': '2024-03-13', 'studyFirstSubmitQcDate': '2024-03-13', 'lastUpdatePostDateStruct': {'date': '2024-04-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-14', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Hemoglobin typing', 'timeFrame': 'at aged 12 months', 'description': 'Hemoglobin typing will be assessed'}, {'measure': 'C-reactive protein (CRP)', 'timeFrame': 'at aged 6, 9, and 12 months', 'description': 'High sensitivity CRP will be analyzed and will be used for the adjustment of serum ferritin'}, {'measure': 'Alpha-1 acid glycoprotein (AGP)', 'timeFrame': 'at aged 6, 9, and 12 months', 'description': 'AGP will be analyzed and will be used for the adjustment of serum ferritin'}, {'measure': 'Serum transferrin receptor', 'timeFrame': 'at aged 6, 9, and 12 months', 'description': 'Serum transferrin receptor will be assessed to reflect iron status'}, {'measure': 'Serum Retinol Binding Protein (RBP)', 'timeFrame': 'at aged 6, 9, and 12 months', 'description': 'RBP will be assessed to reflect vitamin A status'}], 'primaryOutcomes': [{'measure': 'Anemia status', 'timeFrame': 'at aged 6, 9, and 12 months', 'description': 'Hemoglobin concentration will be assessed and classified as anemia or non-anemia.'}, {'measure': 'Iron status', 'timeFrame': 'at aged 6, 9, and 12 months', 'description': 'Serum ferritin will be assessed to reflect iron status'}], 'secondaryOutcomes': [{'measure': 'Weight', 'timeFrame': 'at aged 6, 9, and 12 months', 'description': 'Body weight will be assessed, and weight-for-age and weight-for-length Z scores will be generated'}, {'measure': 'Length', 'timeFrame': 'at aged 6, 9, and 12 months', 'description': 'Length will be assessed, and length-for-age Z scores and weight-for-length will be generated'}, {'measure': 'Dietary intake', 'timeFrame': 'at aged 6, 9, and 12 months', 'description': 'Dietary intake will be assessed using the 24-hr dietary recall for 3 days'}, {'measure': 'Head circumference (HC)', 'timeFrame': 'at aged 6, 9, and 12 months', 'description': 'HC will be assessed, and head circumference-for-age Z scores will be generated'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Anemia', 'Iron status', 'Infants', 'Iron supplementation'], 'conditions': ['Anemia', 'Iron Status', 'Infants', 'Iron']}, 'descriptionModule': {'briefSummary': 'This study aims to compare the efficacy of daily iron supplementation and weekly iron supplementation in infants aged 6-12 months on the prevalence of anemia, hemoglobin level, and serum ferritin levels. Infants will be enrolled at 6 months and will be randomly assigned to receive either daily or weekly iron supplementation for the first 3 months and will be followed by weekly iron supplementation for another 3 months.', 'detailedDescription': 'This study aims to compare the efficacy of daily iron supplementation and weekly iron supplementation in infants aged 6-12 months on the prevalence of anemia, hemoglobin level, and serum ferritin levels. Normal birth weight and term infants will be enrolled at 6 months based on the inclusion criteria. Eligible participants will be assessed at baseline, including anthropometry, dietary intake, and biochemistry (hemoglobin, iron status, vitamin A status, and inflammation). Participants will then be randomly assigned to receive either daily or weekly iron supplementation for the first 3 months. Participants will be followed up at 9 months for the same assessments and will receive weekly iron supplementation for another 3 months. Participants will be followed up at 12 months and the same assessments will be performed. After that, participants will go back to the routine health care service, weekly iron supplementation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Months', 'minimumAge': '6 Months', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Apparently healthy infant, aged 6 months ± 2 weeks\n* Having a birth weight between 2,500 and 4,000 grams\n* Being born full term (37 to 41 weeks of age + 6 days)\n* Having hemoglobin ≥ 10.5 g/dL\n* Being planned to breastfeed with complementary food and/or complementary foods with formula milk\n\nExclusion Criteria:\n\n* Infants with chronic illnesses or thalassemia clinical signs such as anemia, enlarged liver, or spleen (if parental history suggests the child is at risk of developing a thalassemia disease that may not show clinical symptoms)\n* Previously or currently taking an iron supplement'}, 'identificationModule': {'nctId': 'NCT06318858', 'briefTitle': 'Daily and Weekly Iron Supplementation in Infants', 'organization': {'class': 'OTHER', 'fullName': 'Mahidol University'}, 'officialTitle': 'Efficacy of Daily and Weekly Iron Supplementation on Anemia Prevalence in Thai Infants Aged 6-12 Months', 'orgStudyIdInfo': {'id': 'MU-CIRB 2022/313.1411'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1 daily iron supplementation', 'description': '12.5 mg daily iron syrup supplementation from 6-9 months old, followed by 12.5 mg weekly iron syrup supplementation from 9-12 months old.\n\nInfants aged 6-9 months will receive two iron syrup bottles. One bottle aims for ingestion every Monday of the week, and one bottle aims for ingestion on other days of the week.\n\nAt ages 9-12 months, infants will receive an iron syrup bottle that aims for ingestion every Monday of the week.', 'interventionNames': ['Dietary Supplement: Iron supplement']}, {'type': 'OTHER', 'label': 'Group 2 weekly iron supplementation', 'description': '12.5 mg weekly iron syrup supplementation from 6-12 months old. Infants aged 6-9 months will receive an iron syrup bottle that aims for ingestion every Monday of the week and a placebo bottle that aims for ingestion on other days of the week.\n\nAt ages 9-12 months, infants will receive an iron syrup bottle that aims for ingestion every Monday of the week.', 'interventionNames': ['Dietary Supplement: Iron supplement']}], 'interventions': [{'name': 'Iron supplement', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Group 1: 12.5 mg daily iron syrup supplementation from 6-9 months old', 'armGroupLabels': ['Group 1 daily iron supplementation', 'Group 2 weekly iron supplementation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '73110', 'city': 'Sam Phran', 'state': 'Changwat Nakhon Pathom', 'status': 'RECRUITING', 'country': 'Thailand', 'contacts': [{'name': 'Tinnakorn Chuenchom, MD', 'role': 'CONTACT', 'phone': '6634311021', 'phoneExt': '105'}, {'name': 'Somchai Janelapwattanakul, MD', 'role': 'CONTACT', 'phone': '6634352052', 'phoneExt': '4001'}], 'facility': 'Samphran District Hospital', 'geoPoint': {'lat': 13.72698, 'lon': 100.21526}}], 'centralContacts': [{'name': 'Tippawan Pongcharoen, PhD', 'role': 'CONTACT', 'email': 'tippawan.pon@mahidol.ac.th', 'phone': '66813749901'}, {'name': 'Poonyanuch Chongjaroenjai, MD', 'role': 'CONTACT', 'email': 'poonyanuch@sut.ac.th', 'phone': '66899497799'}], 'overallOfficials': [{'name': 'Tippawan Pongcharoen, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mahidol University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mahidol University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Suranaree University of Technology', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}