Ignite Creation Date:
2025-12-24 @ 1:49 PM
Ignite Modification Date:
2025-12-28 @ 11:40 AM
Study NCT ID:
NCT04451395
Status:
COMPLETED
Last Update Posted:
2021-07-27
First Post:
2020-06-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Investigating Pathways Between Maternal Nutritional Status, Breastmilk Composition, and Infant Linear Growth in Rural Pakistan
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D061186', 'term': 'Breast Milk Expression'}], 'ancestors': [{'id': 'D001942', 'term': 'Breast Feeding'}, {'id': 'D005247', 'term': 'Feeding Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 196}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-08-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2021-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-07-26', 'studyFirstSubmitDate': '2020-06-22', 'studyFirstSubmitQcDate': '2020-06-25', 'lastUpdatePostDateStruct': {'date': '2021-07-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maternal BMI', 'timeFrame': '3 months postpartum'}, {'measure': 'Maternal dietary diversity score', 'timeFrame': '3 months postpartum', 'description': 'Minimum score: 0, maximum score: 10'}, {'measure': 'Maternal hemoglobin concentration', 'timeFrame': '3 months postpartum'}, {'measure': 'Maternal supplement adherence', 'timeFrame': '3 months postpartum', 'description': 'Determined by report (options: 0, 25, 50, 75, or 100%)'}, {'measure': 'Breastmilk macronutrient composition', 'timeFrame': '3 months postpartum'}, {'measure': 'Breastmilk micronutrient composition', 'timeFrame': '3 months postpartum'}, {'measure': 'Infant length', 'timeFrame': '3 months postpartum'}], 'secondaryOutcomes': [{'measure': 'Infant weight', 'timeFrame': '3 months postpartum'}, {'measure': 'Infant middle-upper arm circumference', 'timeFrame': '3 months postpartum'}, {'measure': 'Infant head circumference', 'timeFrame': '3 months postpartum'}, {'measure': 'Breastmilk bioactive composition', 'timeFrame': '3 months postpartum'}, {'measure': 'Breastmilk microbiome', 'timeFrame': '3 months postpartum'}, {'measure': 'Infant microbiome', 'timeFrame': '3 months postpartum'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Breast Milk Collection', 'Infant Development']}, 'referencesModule': {'references': [{'pmid': '40409469', 'type': 'DERIVED', 'citation': "Baxter JB, Wasan Y, Daniel AI, Begum K, Hussain A, Iqbal J, Aufreiter S, Beggs MR, Duan L, Greco A, Huang C, Soofi S, Bandsma RH, Bhutta ZA, O'Connor DL. Maternal multiple micronutrient supplementation in rural Pakistan increased some milk micronutrient concentrations, but not infant growth, at three-months postpartum: a randomized controlled trial substudy. Am J Clin Nutr. 2025 Jul;122(1):174-184. doi: 10.1016/j.ajcnut.2025.05.019. Epub 2025 May 21."}]}, 'descriptionModule': {'briefSummary': 'Breastmilk is considered optimal for infant growth and development. However, evidence suggests that breastmilk composition can vary according to maternal nutritional status. Among women in Pakistan, there is a high burden of undernutrition and micronutrient deficiencies. As well, the prevalence of early stunting among Pakistani infants is high. Using a hypothesized pathway model, this study will assess pathways between maternal nutritional status, breastmilk composition, and infant linear growth. This is a substudy to the Matiari emPowerment and Preconception Supplementation (MaPPS) Trial (ClinicalTrials.gov Identifier: NCT03287882).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '25 Years', 'minimumAge': '15 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Enrolled in the MaPPS Trial\n* Mothers must report practicing exclusive or predominant breastfeeding (i.e., breastmilk only or breastmilk and non-nutritive feeds only)\n* The infant must be term-born (\\>37 weeks gestation)\n* Infant must be 3 months ± 30 days old at the time of recruitment\n* Mothers must be willing to provide a complete breastmilk expression from one breast\n* Intervention arm only: mother reports compliance with study-administered MMN supplements at least 50% of the time (i.e., 4 out of 7 days per week)\n* Able to provide informed consent\n\nExclusion Criteria:\n\n* Mother reports mixed feeding in her infant with nutritive feeds (i.e., any provision of formula or animal milk)\n* The infant was born preterm (earlier than 37 weeks gestation)\n* Mother does not wish to provide a complete breast expression of one breast\n* Intervention arm: mother reports compliance with MMN supplements \\<50% of the time'}, 'identificationModule': {'nctId': 'NCT04451395', 'briefTitle': 'Investigating Pathways Between Maternal Nutritional Status, Breastmilk Composition, and Infant Linear Growth in Rural Pakistan', 'organization': {'class': 'OTHER', 'fullName': 'Aga Khan University'}, 'officialTitle': 'Investigating Pathways Between Maternal Nutritional Status, Breastmilk Composition, and Infant Linear Growth in Rural Pakistan', 'orgStudyIdInfo': {'id': '2020-3676-10314'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Multiple micronutrients (UNIMMAP composition)', 'description': 'The intervention is an oral tablet containing 15 different vitamins and minerals at the UNIMMAP composition (includes 30 mg iron, 400 μg folic acid, 15 mg zinc, 2 mg copper, 65 μg selenium, 800 μg RE vitamin A, 1.4 mg vitamin B1, 1.4 mg vitamin B2, 18 mg niacin, 1.9 mg vitamin B6, 2.6 μg vitamin B12, 70 mg vitamin C, 5 μg vitamin D, 10 mg vitamin E and 150 μg iodine). Each tablet is small (approximately 10 mm diameter) and has been procured using the UNICEF supply catalogue. A single MMN supplementation dose will consist of a single tablet..The supplement is provided within the parent trial.\n\nOther Name: UNICEF, Micronutrient tabs, pregnancy/PAC-1000', 'interventionNames': ['Dietary Supplement: Multiple micronutrients (UNIMMAP composition)']}, {'type': 'NO_INTERVENTION', 'label': 'Standard of care', 'description': 'Daily iron and folic acid supplementation provided through the existing public health system.'}], 'interventions': [{'name': 'Multiple micronutrients (UNIMMAP composition)', 'type': 'DIETARY_SUPPLEMENT', 'description': 'The intervention is an oral tablet containing 15 different vitamins and minerals at the UNIMMAP composition (includes 30 mg iron, 400 μg folic acid, 15 mg zinc, 2 mg copper, 65 μg selenium, 800 μg RE vitamin A, 1.4 mg vitamin B1, 1.4 mg vitamin B2, 18 mg niacin, 1.9 mg vitamin B6, 2.6 μg vitamin B12, 70 mg vitamin C, 5 μg vitamin D, 10 mg vitamin E and 150 μg iodine). Each tablet is small (approximately 10 mm diameter) and has been procured using the UNICEF supply catalogue. A single MMN supplementation dose will consist of a single tablet.\n\nOther Name: UNICEF, Micronutrient tabs, pregnancy/PAC-1000', 'armGroupLabels': ['Multiple micronutrients (UNIMMAP composition)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Matiari', 'state': 'Sindh', 'country': 'Pakistan', 'facility': 'Matiari Research and Training Centre', 'geoPoint': {'lat': 25.59709, 'lon': 68.4467}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Please contact the Primary Investigator directly for more details.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aga Khan University', 'class': 'OTHER'}, 'collaborators': [{'name': 'The Hospital for Sick Children', 'class': 'OTHER'}, {'name': 'University of Toronto', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Founding Chair, Centre of Excellence in Women and Child Health', 'investigatorFullName': 'Dr Zulfiqar Ahmed Bhutta', 'investigatorAffiliation': 'Aga Khan University'}}}}