Ignite Creation Date:
2025-12-24 @ 11:34 PM
Ignite Modification Date:
2025-12-25 @ 9:22 PM
Study NCT ID:
NCT06069856
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-06-24
First Post:
2023-09-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Multiple Micronutrient Supplementation (MMS) vs IFA Acceptability Crossover Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D007501', 'term': 'Iron'}], 'ancestors': [{'id': 'D019216', 'term': 'Metals, Heavy'}, {'id': 'D004602', 'term': 'Elements'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D028561', 'term': 'Transition Elements'}, {'id': 'D008670', 'term': 'Metals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) The trial is quadruple blind with all trial participants, outcome assessors (research staff and care providers), investigators, and trials statistician and data analysts being unable to determine the allocated trial arm for any trial participant or identify trial participants who are on the same trial regimen.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 130}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2026-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-18', 'studyFirstSubmitDate': '2023-09-15', 'studyFirstSubmitQcDate': '2023-09-29', 'lastUpdatePostDateStruct': {'date': '2025-06-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Acceptability of formulation', 'timeFrame': 'At two months of taking each regimen', 'description': 'To assess acceptability of MMS formulation with 60 mg of iron and IFA formulation with 60 mg of iron using Likert scales ranging from 1 (disliked a lot) to 5 (liked a lot).'}], 'secondaryOutcomes': [{'measure': 'Most preferred formulation', 'timeFrame': 'At four months (after taking both regimens)', 'description': 'To assess participated reported preference of MMS formulation with 60 mg of iron and IFA formulation with 60 mg of iron by asking participants which supplement they like the best.'}, {'measure': 'Side Effects of formulation', 'timeFrame': 'At two months of taking each regimen', 'description': 'To assess the percentage of patients experiencing side effects of MMS formulation with 60 mg of iron and IFA formulation with 60 mg of iron'}, {'measure': 'Adherence', 'timeFrame': 'At two months of taking each regimen', 'description': 'Percentage pill count of the number of supplements taken'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Acceptability', 'Multiple Micronutrient Supplementation', 'Iron', 'IFA', 'Tanzania'], 'conditions': ['Pregnancy Related']}, 'descriptionModule': {'briefSummary': 'This is an individually randomized mixed methods cross-over trial to assess acceptability, preference, and side effects of IFA formulations with 60 mg of iron to MMS formulations with 60 mg of iron.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Attending first ANC visit at the study clinic\n* Pregnant women ≤ 15 weeks of gestation\n* Aged ≥ 18 years\n* Intending to stay in the study area for the duration of study\n* Provides informed consent\n\nExclusion Criteria:\n\n* Severe anemia (defined as Hb \\<8.5 g/dL per Tanzania standard of care)\n* Sickle cell disease (SS,SC, CC genotype) as tested by HemoTypeSC\n* Concurrent participation in other nutritional supplementation trial\n* Pregnant women with disability or condition which would impair their ability to provide informed consent and complete study procedures.'}, 'identificationModule': {'nctId': 'NCT06069856', 'acronym': 'MIFA-ACT', 'briefTitle': 'Multiple Micronutrient Supplementation (MMS) vs IFA Acceptability Crossover Trial', 'organization': {'class': 'OTHER', 'fullName': 'George Washington University'}, 'officialTitle': 'Individually Randomized Crossover Trial of Multiple Micronutrient Supplementation (MMS) Versus IFA During Pregnancy in Tanzania', 'orgStudyIdInfo': {'id': 'MIFA-ACT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MMS with 60 mg of iron first, then IFA with 60 mg of iron', 'description': 'Women will receive the first regimen (MMS with 60 mg of iron) for 2 months and then crossover on to the second regimen (IFA with 60 mg of iron) for 2 months', 'interventionNames': ['Dietary Supplement: Iron Folic Acid Tablets with 60 mg of iron', 'Dietary Supplement: Multiple Micronutrient Supplements with 60 mg of elemental iron']}, {'type': 'EXPERIMENTAL', 'label': 'IFA with 60 mg of iron first, then MMS with 60 mg of iron', 'description': 'Women will receive the first regimen (IFA with 60 mg of iron) for 2 months and then crossover on to the second regimen (MMS with 60 mg of iron) for 2 months', 'interventionNames': ['Dietary Supplement: Iron Folic Acid Tablets with 60 mg of iron', 'Dietary Supplement: Multiple Micronutrient Supplements with 60 mg of elemental iron']}], 'interventions': [{'name': 'Iron Folic Acid Tablets with 60 mg of iron', 'type': 'DIETARY_SUPPLEMENT', 'description': 'IFA with 60 mg iron is an intervention group. IFA with 60 mg of iron will be taken orally once daily from the time of randomization', 'armGroupLabels': ['IFA with 60 mg of iron first, then MMS with 60 mg of iron', 'MMS with 60 mg of iron first, then IFA with 60 mg of iron']}, {'name': 'Multiple Micronutrient Supplements with 60 mg of elemental iron', 'type': 'DIETARY_SUPPLEMENT', 'description': 'MMS with 60 mg iron is an intervention group. MMS with 60 mg of iron plus standard UNIMMAP formulation for other 14 micronutrients will be taken orally once daily from the time of randomization.', 'armGroupLabels': ['IFA with 60 mg of iron first, then MMS with 60 mg of iron', 'MMS with 60 mg of iron first, then IFA with 60 mg of iron']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Emily R Smith, ScD, MPH', 'role': 'CONTACT', 'email': 'emilysmith@gwu.edu', 'phone': '202-994-3589'}, {'name': 'Christopher R Sudfeld, ScD, ScM', 'role': 'CONTACT', 'email': 'csudfeld@hsph.harvard.edu'}], 'overallOfficials': [{'name': 'Blair Wylie, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Columbia University'}, {'name': 'Honorati Masanja, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ifakara Health Institute'}, {'name': 'Alfa Muhihi, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Africa Academy of Public Health'}, {'name': 'Andrea Pembe, MD, MMed, PhD, FCOG', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Muhimbili University of Health and Allied Sciences'}, {'name': 'Emily R Smith, ScD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The George Washington University'}, {'name': 'Christopher R Sudfeld, ScD, ScM', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Harvard University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'George Washington University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ifakara Health Institute', 'class': 'OTHER'}, {'name': 'Harvard School of Public Health (HSPH)', 'class': 'OTHER'}, {'name': 'Muhimbili University of Health and Allied Sciences', 'class': 'OTHER'}, {'name': 'Africa Academy for Public Health', 'class': 'OTHER'}, {'name': 'Columbia University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Emily Smith', 'investigatorAffiliation': 'George Washington University'}}}}