Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-31 @ 10:23 AM
Study NCT ID:
NCT07435766
Status:
RECRUITING
Last Update Posted:
2026-02-27
First Post:
2026-02-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Iron Absorption From IFA and MMS Supplements in Kenyan Women During the Second Trimester of Pregnancy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000090463', 'term': 'Iron Deficiencies'}], 'ancestors': [{'id': 'D019189', 'term': 'Iron Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, '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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-03-02', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-20', 'studyFirstSubmitDate': '2026-02-20', 'studyFirstSubmitQcDate': '2026-02-20', 'lastUpdatePostDateStruct': {'date': '2026-02-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fractional iron absorption (%)', 'timeFrame': 'Day 19', 'description': 'Fractional iron absorption calculated as the percentage of the administered labelled iron dose incorporated into red blood cells. The calculation is based on the measured shift in iron isotope ratios in blood samples collected 14 days after intake compared to baseline.'}, {'measure': 'Fractional iron absorption (%)', 'timeFrame': 'Day 36', 'description': 'Fractional iron absorption calculated as the percentage of the administered labelled iron dose incorporated into red blood cells. The calculation is based on the measured shift in iron isotope ratios in blood samples collected 14 days after intake compared to baseline.'}, {'measure': 'Fractional iron absorption (%)', 'timeFrame': 'Day 53', 'description': 'Fractional iron absorption calculated as the percentage of the administered labelled iron dose incorporated into red blood cells. The calculation is based on the measured shift in iron isotope ratios in blood samples collected 14 days after intake compared to baseline.'}, {'measure': 'Fractional iron absorption (%)', 'timeFrame': 'Day 70', 'description': 'Fractional iron absorption calculated as the percentage of the administered labelled iron dose incorporated into red blood cells. The calculation is based on the measured shift in iron isotope ratios in blood samples collected 14 days after intake compared to baseline.'}], 'secondaryOutcomes': [{'measure': 'Hepcidin [µg/dL]', 'timeFrame': 'Day 19', 'description': 'Systemic iron regulator'}, {'measure': 'Hepcidin [µg/dL]', 'timeFrame': 'Day 20/21', 'description': 'Systemic iron regulator'}, {'measure': 'Hepcidin [µg/dL]', 'timeFrame': 'Day 22', 'description': 'Systemic iron regulator'}, {'measure': 'Hepcidin [µg/dL]', 'timeFrame': 'Day 36', 'description': 'Systemic iron regulator'}, {'measure': 'Hepcidin [µg/dL]', 'timeFrame': 'Day 37/38', 'description': 'Systemic iron regulator'}, {'measure': 'Hepcidin [µg/dL]', 'timeFrame': 'Day 39', 'description': 'Systemic iron regulator'}, {'measure': 'Hepcidin [µg/dL]', 'timeFrame': 'Day 53', 'description': 'Systemic iron regulator'}, {'measure': 'Hepcidin [µg/dL]', 'timeFrame': 'Day 54/55', 'description': 'Systemic iron regulator'}, {'measure': 'Hepcidin [µg/dL]', 'timeFrame': 'Day 56', 'description': 'Systemic iron regulator'}, {'measure': 'Hemoglobin (g/dL)', 'timeFrame': 'Day 1', 'description': 'Iron status marker'}, {'measure': 'Hemoglobin (g/dL)', 'timeFrame': 'Day 19', 'description': 'Iron status marker'}, {'measure': 'Hemoglobin (g/dL)', 'timeFrame': 'Day 36', 'description': 'Iron status marker'}, {'measure': 'Hemoglobin (g/dL)', 'timeFrame': 'Day 53', 'description': 'Iron status marker'}, {'measure': 'Hemoglobin (g/dL)', 'timeFrame': 'Day 70', 'description': 'Iron status marker'}, {'measure': 'Serum Ferritin (µg/L)', 'timeFrame': 'Day 1', 'description': 'Iron status marker'}, {'measure': 'Serum Ferritin (µg/L)', 'timeFrame': 'Day 19', 'description': 'Iron status marker'}, {'measure': 'Serum Ferritin (µg/L)', 'timeFrame': 'Day 36', 'description': 'Iron status marker'}, {'measure': 'Serum Ferritin (µg/L)', 'timeFrame': 'Day 53', 'description': 'Iron status marker'}, {'measure': 'C-reactive protein (mg/L)', 'timeFrame': 'Day 1', 'description': 'Chronic inflammation marker'}, {'measure': 'C-reactive protein (mg/L)', 'timeFrame': 'Day 19', 'description': 'Chronic inflammation marker'}, {'measure': 'C-reactive protein (mg/L)', 'timeFrame': 'Day 36', 'description': 'Chronic inflammation marker'}, {'measure': 'C-reactive protein (mg/L)', 'timeFrame': 'Day 53', 'description': 'Chronic inflammation marker'}, {'measure': 'Alpha-1-acid Glycoprotein (g/L)', 'timeFrame': 'Day 1', 'description': 'Acute inflammation marker'}, {'measure': 'Alpha-1-acid Glycoprotein (g/L)', 'timeFrame': 'Day 19', 'description': 'Acute inflammation marker'}, {'measure': 'Alpha-1-acid Glycoprotein (g/L)', 'timeFrame': 'Day 36', 'description': 'Acute inflammation marker'}, {'measure': 'Alpha-1-acid Glycoprotein (g/L)', 'timeFrame': 'Day 53', 'description': 'Acute inflammation marker'}, {'measure': 'soluble Transferrin Receptor (mg/L)', 'timeFrame': 'Day 1', 'description': 'Iron status marker'}, {'measure': 'soluble Transferrin Receptor (mg/L)', 'timeFrame': 'Day 19', 'description': 'Iron status marker'}, {'measure': 'soluble Transferrin Receptor (mg/L)', 'timeFrame': 'Day 36', 'description': 'Iron status marker'}, {'measure': 'soluble Transferrin Receptor (mg/L)', 'timeFrame': 'Day 53', 'description': 'Iron status marker'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Iron Supplements', 'Dietary Supplements', 'Iron Deficiency', 'Pregnancy', 'Stable Iron Isotopes', 'Iron Absorption'], 'conditions': ['Pregnancy']}, 'descriptionModule': {'briefSummary': 'This study evaluates iron absorption from three antenatal supplements, 30 mg MMS, 60 mg MMS, and 60 mg IFA, in 50 pregnant Kenyan women in their second trimester. Using a randomized crossover design and stable iron isotopes, we will compare bioavailability in both fasted and fed states. Additionally, the trial will investigate if daily dosing triggers a hepcidin response that inhibits subsequent absorption, testing whether alternate-day dosing is a more effective strategy for treating iron deficiency.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* female\n* pregnant at gestational age 12 (±1) weeks (dated by ultrasound)\n* age 18 to 35 y\n* Hb concentration ≥80 g/L\n* absence of significant inflammation\n* body weight \\<80 kg\n* no major chronic diseases\n* no intake of vitamin and mineral supplements outside of this study in the 1-2 weeks between screening and study start and during the study\n* no blood transfusion, blood donation, or significant blood loss over the past 4 months\n\nExclusion Criteria:\n\n* severe anemia (defined as Hb \\<80 g/L)\n* malaria\n* sickle cell disease (SS and SC)\n* hemoglobin C disease (CC).'}, 'identificationModule': {'nctId': 'NCT07435766', 'acronym': 'PROUD', 'briefTitle': 'Iron Absorption From IFA and MMS Supplements in Kenyan Women During the Second Trimester of Pregnancy', 'organization': {'class': 'OTHER', 'fullName': 'ETH Zurich'}, 'officialTitle': 'Comparing Iron Absorption From Multiple Micronutrient Supplements and Iron-folate Supplements: a Stable Isotope Study in Kenyan Pregnant Women', 'orgStudyIdInfo': {'id': 'PROUD'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Supplement crossover with maize porridge, comparison of iron absorption', 'description': '1 Block:\n\nMaize porridge with labelled ferrous fumarate or ferrous sulphate (54Fe, 57Fe or 58Fe) combined with either MMS with 30 mg of iron, MMS with 60 mg of iron, IFA with 60 mg of iron, given at day 1, day 3 and day 5', 'interventionNames': ['Dietary Supplement: MMS with 30 mg iron', 'Dietary Supplement: MMS with 60 mg iron', 'Dietary Supplement: IFA with 60 mg iron']}, {'type': 'EXPERIMENTAL', 'label': 'Supplement crossover with water, everyday vs. every other day', 'description': 'Three blocks in randomized order:\n\nBlock 1: Water with labelled ferrous fumarate (54Fe, 57Fe or 58Fe, randomized) combined with MMS with 30 mg of iron given at day 1, day 2/3 (randomized), day 4\n\nBlock 2: Water with labelled ferrous fumarate (54Fe, 57Fe or 58Fe, randomized) combined with MMS with 60 mg of iron given at day 1, day 2/3 (randomized), day 4\n\nBlock 3: Water with labelled ferrous sulphate (54Fe, 57Fe or 58Fe, randomized) combined with IFA with 60 mg of iron given at day 1, day 2/3 (randomized), day 4', 'interventionNames': ['Dietary Supplement: MMS with 30 mg iron', 'Dietary Supplement: MMS with 60 mg iron', 'Dietary Supplement: IFA with 60 mg iron']}], 'interventions': [{'name': 'MMS with 30 mg iron', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Multiple Micronutrient Supplementation (MMS) with 30 mg of iron given with ferrous fumarate isotope (54Fe, 57Fe, 58Fe)', 'armGroupLabels': ['Supplement crossover with maize porridge, comparison of iron absorption', 'Supplement crossover with water, everyday vs. every other day']}, {'name': 'MMS with 60 mg iron', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Multiple Micronutrient Supplementation (MMS) with 60 mg of iron given with ferrous fumarate isotope (54Fe, 57Fe, 58Fe)', 'armGroupLabels': ['Supplement crossover with maize porridge, comparison of iron absorption', 'Supplement crossover with water, everyday vs. every other day']}, {'name': 'IFA with 60 mg iron', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Iron Folic Acid (IFA) with 60 mg of iron given with ferrous sulphate isotope (54Fe, 57Fe, 58Fe)', 'armGroupLabels': ['Supplement crossover with maize porridge, comparison of iron absorption', 'Supplement crossover with water, everyday vs. every other day']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kwale', 'state': 'Kwale County', 'status': 'RECRUITING', 'country': 'Kenya', 'contacts': [{'name': 'Suzane Nyilima, MSc', 'role': 'CONTACT', 'email': 'suzane.nyilima@gmail.com', 'phone': '+254 702 836210'}], 'facility': 'Kwale Sub County Hospital', 'geoPoint': {'lat': -4.17375, 'lon': 39.45206}}, {'city': 'Msambweni', 'state': 'Kwale County', 'status': 'RECRUITING', 'country': 'Kenya', 'contacts': [{'name': 'Suzane Nyilima, MSc', 'role': 'CONTACT', 'email': 'suzane.nyilima@gmail.com', 'phone': '+254 702 836210'}], 'facility': 'Msambweni County Referral Hospital', 'geoPoint': {'lat': -4.4619, 'lon': 39.48265}}], 'centralContacts': [{'name': 'Laura N Wasserfallen, MSc', 'role': 'CONTACT', 'email': 'laura.wasserfallen@pharma.ethz.ch', 'phone': '+41 76 574 88 52'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ETH Zurich', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr.', 'investigatorFullName': 'Nicole Stoffel', 'investigatorAffiliation': 'ETH Zurich'}}}}