Ignite Creation Date:
2025-12-25 @ 4:51 AM
Ignite Modification Date:
2025-12-26 @ 3:52 AM
Study NCT ID:
NCT04744818
Status:
COMPLETED
Last Update Posted:
2024-01-24
First Post:
2021-01-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Iron Supplementation on Pediatric Vaccine Response
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018798', 'term': 'Anemia, Iron-Deficiency'}, {'id': 'D054198', 'term': 'Precursor Cell Lymphoblastic Leukemia-Lymphoma'}], 'ancestors': [{'id': 'D000747', 'term': 'Anemia, Hypochromic'}, {'id': 'D000740', 'term': 'Anemia'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D000090463', 'term': 'Iron Deficiencies'}, {'id': 'D019189', 'term': 'Iron Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D007945', 'term': 'Leukemia, Lymphoid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 288}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-02-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2023-10-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-22', 'studyFirstSubmitDate': '2021-01-28', 'studyFirstSubmitQcDate': '2021-02-04', 'lastUpdatePostDateStruct': {'date': '2024-01-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Human milk oligosaccharide secretor type', 'timeFrame': '14 weeks of age', 'description': 'secretor yes or no'}, {'measure': 'Erythrocyte zinc protoporphyrin', 'timeFrame': '6 weeks of age'}, {'measure': 'Erythrocyte zinc protoporphyrin', 'timeFrame': '14 weeks of age'}, {'measure': 'Erythrocyte zinc protoporphyrin', 'timeFrame': '24 weeks of age'}, {'measure': 'Erythrocyte zinc protoporphyrin', 'timeFrame': '38 weeks of age'}, {'measure': 'Erythrocyte zinc protoporphyrin', 'timeFrame': '52 weeks of age'}], 'primaryOutcomes': [{'measure': 'Pertussis antibody profile', 'timeFrame': 'from 6 to 24 weeks'}, {'measure': 'Diphtheria antibody profile', 'timeFrame': 'from 6 to 24 weeks'}], 'secondaryOutcomes': [{'measure': 'antiviral immunoglobulin G response', 'timeFrame': '6 weeks of age', 'description': 'Immunoassay'}, {'measure': 'antiviral immunoglobulin G response', 'timeFrame': '24 weeks of age', 'description': 'Immunoassay'}, {'measure': 'infant antiviral immunoglobulin G response', 'timeFrame': '52 weeks of age', 'description': 'Immunoassay'}, {'measure': 'immune cell populations', 'timeFrame': '6 weeks of age', 'description': 'number and type of immune cells'}, {'measure': 'immune cell populations', 'timeFrame': '24 weeks of age', 'description': 'number and type of immune cells'}, {'measure': 'immune cell populations', 'timeFrame': '52 weeks of age', 'description': 'number and type of immune cells'}, {'measure': 'Proteomics', 'timeFrame': '6 weeks of age', 'description': 'Proteins involved in immune response'}, {'measure': 'Proteomics', 'timeFrame': '24 weeks of age', 'description': 'Proteins involved in immune response'}, {'measure': 'Proteomics', 'timeFrame': '52 weeks of age', 'description': 'Proteins involved in immune response'}, {'measure': 'Transcriptomics', 'timeFrame': '24 weeks of age', 'description': 'Genes involved in immune response'}, {'measure': 'Intestinal fatty acid binding protein', 'timeFrame': '6 weeks of age', 'description': 'Gut inflammation'}, {'measure': 'Intestinal fatty acid binding protein', 'timeFrame': '14 weeks of age', 'description': 'Gut inflammation'}, {'measure': 'Intestinal fatty acid binding protein', 'timeFrame': '24 weeks of age', 'description': 'Gut inflammation'}, {'measure': 'Calprotectin', 'timeFrame': '6 weeks of age', 'description': 'Gut inflammation'}, {'measure': 'Calprotectin', 'timeFrame': '14 weeks of age', 'description': 'Gut inflammation'}, {'measure': 'Calprotectin', 'timeFrame': '24 weeks of age', 'description': 'Gut inflammation'}, {'measure': 'Hemoglobin', 'timeFrame': '6 weeks of age'}, {'measure': 'Hemoglobin', 'timeFrame': '14 weeks of age'}, {'measure': 'Hemoglobin', 'timeFrame': '24 weeks of age'}, {'measure': 'Hemoglobin', 'timeFrame': '38 weeks of age'}, {'measure': 'Hemoglobin', 'timeFrame': '52 weeks of age'}, {'measure': 'Plasma iron', 'timeFrame': '6 weeks of age'}, {'measure': 'Plasma iron', 'timeFrame': '14 weeks of age'}, {'measure': 'Plasma iron', 'timeFrame': '24 weeks of age'}, {'measure': 'Plasma iron', 'timeFrame': '38 weeks of age'}, {'measure': 'Plasma iron', 'timeFrame': '52 weeks of age'}, {'measure': 'Plasma ferritin', 'timeFrame': '6 weeks of age'}, {'measure': 'Plasma ferritin', 'timeFrame': '14 weeks of age'}, {'measure': 'Plasma ferritin', 'timeFrame': '24 weeks of age'}, {'measure': 'Plasma ferritin', 'timeFrame': '38 weeks of age'}, {'measure': 'Plasma ferritin', 'timeFrame': '52 weeks of age'}, {'measure': 'soluble transferrin receptor', 'timeFrame': '6 weeks of age'}, {'measure': 'soluble transferrin receptor', 'timeFrame': '14 weeks of age'}, {'measure': 'soluble transferrin receptor', 'timeFrame': '24 weeks of age'}, {'measure': 'soluble transferrin receptor', 'timeFrame': '38 weeks of age'}, {'measure': 'soluble transferrin receptor', 'timeFrame': '52 weeks of age'}, {'measure': 'C-reactive protein', 'timeFrame': '6 weeks of age'}, {'measure': 'C-reactive protein', 'timeFrame': '14 weeks of age'}, {'measure': 'C-reactive protein', 'timeFrame': '24 weeks of age'}, {'measure': 'C-reactive protein', 'timeFrame': '38 weeks of age'}, {'measure': 'C-reactive protein', 'timeFrame': '52 weeks of age'}, {'measure': 'Alpha-glycoprotein', 'timeFrame': '6 weeks of age'}, {'measure': 'Alpha-glycoprotein', 'timeFrame': '14 weeks of age'}, {'measure': 'Alpha-glycoprotein', 'timeFrame': '24 weeks of age'}, {'measure': 'Alpha-glycoprotein', 'timeFrame': '38 weeks of age'}, {'measure': 'Alpha-glycoprotein', 'timeFrame': '52 weeks of age'}, {'measure': 'Tetanus antibody profile', 'timeFrame': 'from 6 to 24 weeks'}, {'measure': 'Haemophilus influenzae b antibody profile', 'timeFrame': 'from 6 to 24 weeks'}, {'measure': 'Pneumococcus antibody profile', 'timeFrame': 'from 6 to 24 weeks'}, {'measure': 'Rotavirus antibody profile', 'timeFrame': 'from 6 to 24 weeks'}, {'measure': 'Polio antibody profile', 'timeFrame': 'from 6 to 24 weeks'}, {'measure': 'Anti-vaccine antibody titers', 'timeFrame': '38 weeks of age'}, {'measure': 'Anti-vaccine antibody titers', 'timeFrame': '52 weeks of age'}, {'measure': 'Anti-vaccine seroconversion', 'timeFrame': '14 weeks of age'}, {'measure': 'Anti-vaccine seroconversion', 'timeFrame': '24 weeks of age'}, {'measure': 'Anti-vaccine seroconversion', 'timeFrame': '38 weeks of age'}, {'measure': 'Anti-vaccine seroconversion', 'timeFrame': '52 weeks of age'}, {'measure': 'Anti-vaccine antibody avidity index', 'timeFrame': '14 weeks of age', 'description': 'percentage of antibodies that remain bound to beads'}, {'measure': 'Anti-vaccine antibody avidity index', 'timeFrame': '24 weeks of age', 'description': 'percentage of antibodies that remain bound to beads'}, {'measure': 'Anti-vaccine antibody avidity index', 'timeFrame': '38 weeks of age', 'description': 'percentage of antibodies that remain bound to beads'}, {'measure': 'Anti-vaccine antibody avidity index', 'timeFrame': '52 weeks of age', 'description': 'percentage of antibodies that remain bound to beads'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Iron-deficiency', 'Iron Deficiency Anemia', 'Vaccination', 'Pediatric ALL']}, 'descriptionModule': {'briefSummary': "ID/IDA affects many young children in Africa. Vaccines provide tremendous benefits in LMIC; however, they currently fail to reach their full potential. We need to better understand the causes of vaccine failure, in order to develop new strategies to improve vaccine immunogenicity.\n\nThis study will contribute to children's health by: (1) providing updated guidelines to better define the prevalence of ID/IDA in early infancy, and its safe and effective control using iron; and (2) providing a new approach to improve response to pediatric vaccines in LMIC, by ensuring adequate iron status at time of vaccination.", 'detailedDescription': 'Two major pediatric public health goals in LMIC are increasing immunization effectiveness and reducing ID/IDA in children. ID/IDA affects many young children in Africa. Current guidelines do not recommend routine testing of hemoglobin in early infancy, as it is generally believed that most infants are born with adequate iron stores to last 6 months. However, many African infants are born with low iron stores and ID/IDA may develop earlier than generally appreciated, within 2-3 months after birth. Vaccines provide tremendous benefits in LMIC; however, they currently fail to reach their full potential. We need to better understand the causes of vaccine failure, in order to develop new strategies to improve vaccine immunogenicity. Despite lower efficacy in LMIC, these vaccines provide a major benefit because the disease burden is so high; however, if approaches can be found to improve immunogenicity, these vaccines would be even more powerful.\n\nFor this study, 6 weeks old infants will be randomly assigned to two study groups. Group 1 will receive iron at time of pediatric vaccinations from age 6-24 weeks. Group 2 will receive no iron at time of pediatric vaccinations. All infants will receive a multivitamin syrup from age 6-24 weeks. All infants remaining ID/IDA at age 24 weeks will receive iron. Infants will be followed-up until age 52 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '45 Days', 'minimumAge': '39 Days', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Mother at least ≥15 years of age.\n* 6 weeks (+/- 3 days) of age\n* Iron deficient (erythrocyte zinc protoporphyrin (ZnPP) \\>61 μmol/mol heme)\n* With or without anemia, but not severely anemic (Hb \\>70 g/L)\n* No malaria\n* No medical condition that precludes study involvement\n* Mother HIV negative\n* Vaginal delivery\n* No iron supplementation prior to study enrolment\n* Not wasted (length for height z score of ≥-2)\n* Not underweight (weight for age z score ≥-2)\n* From the hospital record, term or late preterm delivery (≥34 weeks)\n* Full-time breastfed at least until the screening\n* No vaccines beyond the birth dose of OPV and BCG prior to enrolment'}, 'identificationModule': {'nctId': 'NCT04744818', 'acronym': 'VINO', 'briefTitle': 'Effects of Iron Supplementation on Pediatric Vaccine Response', 'organization': {'class': 'OTHER', 'fullName': 'Swiss Federal Institute of Technology'}, 'officialTitle': 'Effects of Iron Supplementation on Pediatric Vaccine Response', 'orgStudyIdInfo': {'id': 'VINO'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Immediate iron treatment', 'description': 'Iron and multivitamin syrup', 'interventionNames': ['Dietary Supplement: Iron syrup', 'Dietary Supplement: Multivitamin syrup']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Delayed iron treatment', 'description': 'Multivitamin syrup', 'interventionNames': ['Dietary Supplement: Multivitamin syrup']}], 'interventions': [{'name': 'Iron syrup', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Daily supplementation with iron', 'armGroupLabels': ['Immediate iron treatment']}, {'name': 'Multivitamin syrup', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Daily supplementation with multivitamins', 'armGroupLabels': ['Delayed iron treatment', 'Immediate iron treatment']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Msambweni', 'state': 'Kwale County', 'country': 'Kenya', 'facility': 'Msambweni County Referral Hospital', 'geoPoint': {'lat': -4.4619, 'lon': 39.48265}}, {'zip': '8092', 'city': 'Zurich', 'country': 'Switzerland', 'facility': 'Human Nutrition Laboratory ETH Zurich', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jessica Rigutto', 'class': 'OTHER'}, 'collaborators': [{'name': 'Jomo Kenyatta University of Agriculture and Technology Kenya', 'class': 'UNKNOWN'}, {'name': 'Karolinka Institute Sweden', 'class': 'UNKNOWN'}, {'name': 'University of Oxford', 'class': 'OTHER'}, {'name': 'National Institute for Public Health and Environment Netherlands', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Dr. Nicole Stoffel', 'investigatorFullName': 'Jessica Rigutto', 'investigatorAffiliation': 'Swiss Federal Institute of Technology'}}}}