Ignite Creation Date:
2025-12-24 @ 10:55 PM
Ignite Modification Date:
2025-12-25 @ 8:23 PM
Study NCT ID:
NCT06069869
Status:
RECRUITING
Last Update Posted:
2025-10-02
First Post:
2023-09-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Multiple Micronutrient Supplementation (MMS) Iron Dose Acceptability Crossover Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': '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', 'interventionModelDescription': 'Each participant will be randomized to one of 6 sequence orders to receive the three MMS regimens first, second or third in order (e.g., 30, 45, then 60 mg; or 45, 30, then 60 mg; or 45, 60 then 30 mg etc.).'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 156}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-09-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-28', 'studyFirstSubmitDate': '2023-09-15', 'studyFirstSubmitQcDate': '2023-09-29', 'lastUpdatePostDateStruct': {'date': '2025-10-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-10-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Diarrhea', 'timeFrame': 'At one month of taking each regimen', 'description': 'The percentage of patients with self-reported diarrhea symptoms during each intervention period'}, {'measure': 'Heartburn', 'timeFrame': 'At one month of taking each regimen', 'description': 'The percentage of patients with self-reported heartburn symptoms during each intervention period'}, {'measure': 'Constipation', 'timeFrame': 'At one month of taking each regimen', 'description': 'The percentage of patients with self-reported constipation symptoms during each intervention period'}, {'measure': 'Vomiting', 'timeFrame': 'At one month of taking each regimen', 'description': 'The percentage of patients with self-reported vomiting during each intervention period'}, {'measure': 'Nausea', 'timeFrame': 'At one month of taking each regimen', 'description': 'The percentage of patients with self-reported nausea symptoms during each intervention period'}, {'measure': 'Leg cramps', 'timeFrame': 'At one month of taking each regimen', 'description': 'The percentage of patients with self-reported leg cramp symptoms during each intervention period'}, {'measure': 'Lower back/pelvic pain', 'timeFrame': 'At one month of taking each regimen', 'description': 'The percentage of patients with self-reported lower back/pelvic painsymptoms during each intervention period'}], 'primaryOutcomes': [{'measure': 'Acceptability of MMS formulations', 'timeFrame': 'At one month of taking each regimen', 'description': 'Participant reported acceptability of each MMS formulation using Likert scales ranging from 1 (disliked a lot) to 5 (liked a lot).'}], 'secondaryOutcomes': [{'measure': 'Most preferred MMS formulation', 'timeFrame': 'At three months (after taking all three regimens)', 'description': "Participant's reported preference for MMS formulations with 30 mg, 45 mg, or 60 mg of iron by asking which supplement participant likes the best."}, {'measure': 'Least preferred MMS formulation', 'timeFrame': 'At three months (after taking all three regimens)', 'description': "Participant's reported preference for MMS formulations with 30 mg, 45 mg, or 60 mg of iron by asking which supplement participant likes the least."}, {'measure': 'Identification of MMS iron dosage', 'timeFrame': 'At three months (after taking all three regimens)', 'description': 'Percentage of participants that correctly identify their iron dose treatment order'}, {'measure': 'Side effects of MMS formulations', 'timeFrame': 'At one month of taking each regimen', 'description': 'The percentage of patients experiencing any side effect (diarrhea, heartburn, constipation, vomiting, nausea, leg cramps, lower back/pelvic pain) during each intervention period'}, {'measure': 'Adherence', 'timeFrame': 'At one month of taking each regimen', 'description': 'The percentage of days a participant takes a MMS pill out of the total number of days in the intervention period'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Acceptability', 'Multiple Micronutrient Supplementation', 'Iron', 'Tanzania'], 'conditions': ['Pregnancy Related']}, 'descriptionModule': {'briefSummary': 'This is an individually randomized cross-over trial to assess acceptability, preference, and perceived side effects of MMS formulations with 30 mg, 45 mg and 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 Dar es Salaam 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': 'NCT06069869', 'acronym': 'MID-ACT', 'briefTitle': 'Multiple Micronutrient Supplementation (MMS) Iron Dose Acceptability Crossover Trial', 'organization': {'class': 'OTHER', 'fullName': 'George Washington University'}, 'officialTitle': 'Individually Randomized Crossover Trial of Multiple Micronutrient Supplementation (MMS) Iron Dosages During Pregnancy in Tanzania', 'orgStudyIdInfo': {'id': 'MID-ACT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MM 30mg; then MMS 45mg; then MMS 60mg', 'description': 'Participants first receive MMS with 30 mg for one month, then MMS with 45 mg of iron for one month, then MMS with 60 mg of iron for one month', 'interventionNames': ['Dietary Supplement: Multiple Micronutrient Supplements with 30 mg of elemental iron', 'Dietary Supplement: Multiple Micronutrient Supplements with 45 mg of elemental iron', 'Dietary Supplement: Multiple Micronutrient Supplements with 60 mg of elemental iron']}, {'type': 'EXPERIMENTAL', 'label': 'MM 30mg; then MMS 60mg; then MMS 45mg', 'description': 'Participants first receive MMS with 30mg for one month, then MMS with 60mg of iron for one month, then MMS with 45 mg of iron for one month', 'interventionNames': ['Dietary Supplement: Multiple Micronutrient Supplements with 30 mg of elemental iron', 'Dietary Supplement: Multiple Micronutrient Supplements with 45 mg of elemental iron', 'Dietary Supplement: Multiple Micronutrient Supplements with 60 mg of elemental iron']}, {'type': 'EXPERIMENTAL', 'label': 'MM 45mg; then MMS 30mg; then MMS 60mg', 'description': 'Participants first receive MMS with 45 mg for one month, then MMS with 30 mg of iron for one month, then MMS with 60 mg of iron for one month', 'interventionNames': ['Dietary Supplement: Multiple Micronutrient Supplements with 30 mg of elemental iron', 'Dietary Supplement: Multiple Micronutrient Supplements with 45 mg of elemental iron', 'Dietary Supplement: Multiple Micronutrient Supplements with 60 mg of elemental iron']}, {'type': 'EXPERIMENTAL', 'label': 'MM 45 mg; then MMS 60mg; then MMS 30mg', 'description': 'Participants first receive MMS with 45 mg for one month, then MMS with 60 mg of iron for one month, then MMS with 30 mg of iron for one month', 'interventionNames': ['Dietary Supplement: Multiple Micronutrient Supplements with 30 mg of elemental iron', 'Dietary Supplement: Multiple Micronutrient Supplements with 45 mg of elemental iron', 'Dietary Supplement: Multiple Micronutrient Supplements with 60 mg of elemental iron']}, {'type': 'EXPERIMENTAL', 'label': 'MM 60mg; then MMS 30mg; then MMS 45mg', 'description': 'Participants first receive MMS with 60 mg for one month, then MMS with 30 mg of iron for one month, then MMS with 45 mg of iron for one month', 'interventionNames': ['Dietary Supplement: Multiple Micronutrient Supplements with 30 mg of elemental iron', 'Dietary Supplement: Multiple Micronutrient Supplements with 45 mg of elemental iron', 'Dietary Supplement: Multiple Micronutrient Supplements with 60 mg of elemental iron']}, {'type': 'EXPERIMENTAL', 'label': 'MM 60mg; then MMS 45mg; then MMS 30mg', 'description': 'Participants first receive MMS with 60 mg for one month, then MMS with 45 mg of iron for one month, then MMS with 30 mg of iron for one month', 'interventionNames': ['Dietary Supplement: Multiple Micronutrient Supplements with 30 mg of elemental iron', 'Dietary Supplement: Multiple Micronutrient Supplements with 45 mg of elemental iron', 'Dietary Supplement: Multiple Micronutrient Supplements with 60 mg of elemental iron']}], 'interventions': [{'name': 'Multiple Micronutrient Supplements with 30 mg of elemental iron', 'type': 'DIETARY_SUPPLEMENT', 'description': 'MMS with 30 mg iron is the active comparator group. The standard UNIMMAP MMS formulation includes 30 mg of iron which will be taken orally once daily for one month.', 'armGroupLabels': ['MM 30mg; then MMS 45mg; then MMS 60mg', 'MM 30mg; then MMS 60mg; then MMS 45mg', 'MM 45 mg; then MMS 60mg; then MMS 30mg', 'MM 45mg; then MMS 30mg; then MMS 60mg', 'MM 60mg; then MMS 30mg; then MMS 45mg', 'MM 60mg; then MMS 45mg; then MMS 30mg']}, {'name': 'Multiple Micronutrient Supplements with 45 mg of elemental iron', 'type': 'DIETARY_SUPPLEMENT', 'description': 'MMS with 45 mg iron is an intervention group. MMS with 45 mg of iron plus standard UNIMMAP formulation for other 14 micronutrients will be taken orally once daily for one month.', 'armGroupLabels': ['MM 30mg; then MMS 45mg; then MMS 60mg', 'MM 30mg; then MMS 60mg; then MMS 45mg', 'MM 45 mg; then MMS 60mg; then MMS 30mg', 'MM 45mg; then MMS 30mg; then MMS 60mg', 'MM 60mg; then MMS 30mg; then MMS 45mg', 'MM 60mg; then MMS 45mg; then MMS 30mg']}, {'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 for one month.', 'armGroupLabels': ['MM 30mg; then MMS 45mg; then MMS 60mg', 'MM 30mg; then MMS 60mg; then MMS 45mg', 'MM 45 mg; then MMS 60mg; then MMS 30mg', 'MM 45mg; then MMS 30mg; then MMS 60mg', 'MM 60mg; then MMS 30mg; then MMS 45mg', 'MM 60mg; then MMS 45mg; then MMS 30mg']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Dar es Salaam', 'status': 'RECRUITING', 'country': 'Tanzania', 'contacts': [{'name': 'Andrea Pembe, MD', 'role': 'CONTACT', 'email': 'bpembe@muhas.ac.tz', 'phone': '255-754-262-483'}], 'facility': 'Muhimbili University of Health and Allied Sciences', 'geoPoint': {'lat': -6.82349, 'lon': 39.26951}}], '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 for Public Health'}, {'name': 'Andreas 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'}}}}