Ignite Creation Date:
2025-12-25 @ 4:17 AM
Ignite Modification Date:
2025-12-26 @ 3:18 AM
Study NCT ID:
NCT04915820
Status:
COMPLETED
Last Update Posted:
2025-09-04
First Post:
2021-05-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Iron and COVID-19 Vaccine Response
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018798', 'term': 'Anemia, Iron-Deficiency'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C522335', 'term': 'ferric carboxymaltose'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 121}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-05-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2021-09-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-27', 'studyFirstSubmitDate': '2021-05-28', 'studyFirstSubmitQcDate': '2021-06-04', 'lastUpdatePostDateStruct': {'date': '2025-09-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2021-06-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Antibody titers', 'timeFrame': 'day 35'}, {'measure': 'Antibody titers', 'timeFrame': 'day 63'}, {'measure': 'Seroconversion', 'timeFrame': 'day 35'}, {'measure': 'Seroconversion', 'timeFrame': 'day 63'}, {'measure': 'Antibody avidity index', 'timeFrame': 'day 35', 'description': 'percentage of antibodies that remain bound to beads'}, {'measure': 'Antibody avidity index', 'timeFrame': 'day 63', 'description': 'percentage of antibodies that remain bound to beads'}], 'secondaryOutcomes': [{'measure': 'antiviral immunoglobulin G response antiviral immunoglobulin G response antiviral immunoglobulin G response antiviral immunoglobulin G response', 'timeFrame': 'day 0', 'description': 'immunoassay'}, {'measure': 'antiviral immunoglobulin G response antiviral immunoglobulin G response antiviral immunoglobulin G response antiviral immunoglobulin G response', 'timeFrame': 'day 7', 'description': 'immunoassay'}, {'measure': 'antiviral immunoglobulin G response antiviral immunoglobulin G response antiviral immunoglobulin G response antiviral immunoglobulin G response', 'timeFrame': 'day 35', 'description': 'immunoassay'}, {'measure': 'antiviral immunoglobulin G response antiviral immunoglobulin G response antiviral immunoglobulin G response antiviral immunoglobulin G response', 'timeFrame': 'day 63', 'description': 'immunoassay'}, {'measure': 'immune cell populations', 'timeFrame': 'day 0', 'description': 'number and type of immune cells'}, {'measure': 'immune cell populations', 'timeFrame': 'day 7', 'description': 'number and type of immune cells'}, {'measure': 'immune cell populations', 'timeFrame': 'day 35', 'description': 'number and type of immune cells'}, {'measure': 'immune cell populations', 'timeFrame': 'day63', 'description': 'number and type of immune cells'}, {'measure': 'Proteomics', 'timeFrame': 'day 0', 'description': 'Proteins involved in immune response'}, {'measure': 'Proteomics', 'timeFrame': 'day 7', 'description': 'Proteins involved in immune response'}, {'measure': 'Proteomics', 'timeFrame': 'day 35', 'description': 'Proteins involved in immune response'}, {'measure': 'Proteomics', 'timeFrame': 'day 63', 'description': 'Proteins involved in immune response'}, {'measure': 'Transcriptomics', 'timeFrame': 'day 0', 'description': 'Genes involved in immune response'}, {'measure': 'Transcriptomics', 'timeFrame': 'day 7', 'description': 'Genes involved in immune response'}, {'measure': 'Transcriptomics', 'timeFrame': 'day 35', 'description': 'Genes involved in immune response'}, {'measure': 'Transcriptomics', 'timeFrame': 'day 63', 'description': 'Genes involved in immune response'}, {'measure': 'Immune cell cytokine secretion', 'timeFrame': 'day 7', 'description': 'ELISpot'}, {'measure': 'Immune cell cytokine secretion', 'timeFrame': 'day 35', 'description': 'ELISpot'}, {'measure': 'Hemoglobin', 'timeFrame': 'day 0', 'description': 'iron status parameter'}, {'measure': 'Hemoglobin', 'timeFrame': 'day 7', 'description': 'iron status parameter'}, {'measure': 'Hemoglobin', 'timeFrame': 'day 35', 'description': 'iron status parameter'}, {'measure': 'Hemoglobin', 'timeFrame': 'day 63', 'description': 'iron status parameter'}, {'measure': 'Plasma ferritin', 'timeFrame': 'day 0', 'description': 'iron status parameter'}, {'measure': 'Plasma ferritin', 'timeFrame': 'day 7', 'description': 'iron status parameter'}, {'measure': 'Plasma ferritin', 'timeFrame': 'day 35', 'description': 'iron status parameter'}, {'measure': 'Plasma ferritin', 'timeFrame': 'day 63', 'description': 'iron status parameter'}, {'measure': 'Transferrin receptor', 'timeFrame': 'day 0', 'description': 'iron status parameter'}, {'measure': 'Transferrin receptor', 'timeFrame': 'day 7', 'description': 'iron status parameter'}, {'measure': 'Transferrin receptor', 'timeFrame': 'day 35', 'description': 'iron status parameter'}, {'measure': 'Transferrin receptor', 'timeFrame': 'day 63', 'description': 'iron status parameter'}, {'measure': 'Transferrin saturation', 'timeFrame': 'day 0', 'description': 'iron status parameter'}, {'measure': 'Transferrin saturation', 'timeFrame': 'day 7', 'description': 'iron status parameter'}, {'measure': 'Transferrin saturation', 'timeFrame': 'day 35', 'description': 'iron status parameter'}, {'measure': 'Transferrin saturation', 'timeFrame': 'day 63', 'description': 'iron status parameter'}, {'measure': 'C-reactive protein', 'timeFrame': 'day 0', 'description': 'inflammation status parameter'}, {'measure': 'C-reactive protein', 'timeFrame': 'day 7', 'description': 'inflammation status parameter'}, {'measure': 'C-reactive protein', 'timeFrame': 'day 35', 'description': 'inflammation status parameter'}, {'measure': 'C-reactive protein', 'timeFrame': 'day 63', 'description': 'inflammation status parameter'}, {'measure': 'Alpha-glycoprotein', 'timeFrame': 'day 0', 'description': 'inflammation status parameter'}, {'measure': 'Alpha-glycoprotein', 'timeFrame': 'day 7', 'description': 'inflammation status parameter'}, {'measure': 'Alpha-glycoprotein', 'timeFrame': 'day 35', 'description': 'inflammation status parameter'}, {'measure': 'Alpha-glycoprotein', 'timeFrame': 'day 63', 'description': 'inflammation status parameter'}, {'measure': 'retinol binding protein', 'timeFrame': 'day 0', 'description': 'vitamin A status marker'}, {'measure': 'retinol binding protein', 'timeFrame': 'day 7', 'description': 'vitamin A status marker'}, {'measure': 'retinol binding protein', 'timeFrame': 'day 35', 'description': 'vitamin A status marker'}, {'measure': 'retinol binding protein', 'timeFrame': 'day 63', 'description': 'vitamin A status marker'}, {'measure': 'plasma zinc', 'timeFrame': 'day 35'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Iron Deficiency Anemia', 'Vaccine Response Impaired', 'COVID-19 Vaccine', 'Iron Deficiency Anemia Treatment']}, 'descriptionModule': {'briefSummary': 'Vaccines often underperform in Africa compared to high-income countries. Why vaccines do not work as well in Africa remains uncertain. Malnutrition likely plays a role. Our study objective is to assess whether iron deficiency anaemia in young women impairs their immune response to the COVID-19 vaccine, and whether iron treatment improves their response.', 'detailedDescription': 'Group 1 (immediate iron treatment) will receive iron treatment before vaccination. Women in both groups will receive the 1st dose of the COVID-19 vaccine. Vaccine response will be measured 28 and 56 days after the first vaccine administration in both groups. At 28 days, participants will receive the 2nd dose of the COVID-19 vaccine. Group 2 (delayed iron treatment) will receive iron treatment at study end.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n18-55 years old Zinc protoporphyrin \\> or equal 40 mmol/mol heme hemoglobin \\< or equal 109 g/L no malaria no known HIV infection no medical condition that precludes study involvement no iron supplementation 1 week prior to study start no recent tuberculosis infection no vaccination of yellow fever or influenza prior to enrolment not pregnant\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT04915820', 'briefTitle': 'Iron and COVID-19 Vaccine Response', 'organization': {'class': 'OTHER', 'fullName': 'Jomo Kenyatta University of Agriculture and Technology'}, 'officialTitle': 'Iron and Vaccine-preventable Viral Disease', 'orgStudyIdInfo': {'id': 'DIVA I'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Immediate iron treatment', 'description': 'intravenous iron carboxymaltose before vaccination', 'interventionNames': ['Dietary Supplement: Ferinject']}, {'type': 'NO_INTERVENTION', 'label': 'No iron treatment', 'description': 'no intravenous iron carboxymaltose before vaccination'}], 'interventions': [{'name': 'Ferinject', 'type': 'DIETARY_SUPPLEMENT', 'description': 'intravenous iron carboxymaltose', 'armGroupLabels': ['Immediate iron treatment']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Msambweni', 'state': 'Kwale County', 'country': 'Kenya', 'facility': 'Msambweni County Referral Hospital', 'geoPoint': {'lat': -4.4619, 'lon': 39.48265}}], 'overallOfficials': [{'name': 'Simon Karanja, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'JKUAT Nairobi'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jomo Kenyatta University of Agriculture and Technology', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD', 'investigatorFullName': 'Prof Simon Karanja', 'investigatorAffiliation': 'Jomo Kenyatta University of Agriculture and Technology'}}}}