Ignite Creation Date:
2025-12-25 @ 12:40 AM
Ignite Modification Date:
2025-12-25 @ 10:51 PM
Study NCT ID:
NCT05398367
Status:
RECRUITING
Last Update Posted:
2025-03-28
First Post:
2022-05-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Galactagogue Use in Lactating Women With Low Milk Supply
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': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR'], 'maskingDescription': 'Double-blind randomized controlled trial'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants will be randomized into one of four treatment groups: Oat Mama Lactation Supplement (O), moringa supplement (M), shatavari supplement (S), or control (C).'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-03-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2026-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-24', 'studyFirstSubmitDate': '2022-05-23', 'studyFirstSubmitQcDate': '2022-05-25', 'lastUpdatePostDateStruct': {'date': '2025-03-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Breast Milk Supply', 'timeFrame': 'Intervention will last 20 days and 24-hour breast milk expression volume will be measured on day 1, 10, and 20 and used to calculate change in 24-hour breast milk expression volume over the trial period', 'description': 'Change in breast milk supply will be evaluated using 24-hour breast milk expression volume'}, {'measure': 'Change in Serum Prolactin', 'timeFrame': 'Intervention will last 20 days and blood samples will be taken on day 1, 10, am 20 and change in serum prolactin will be measured using a human serum prolactin ELISA kit', 'description': 'Change in serum prolactin levels will be evaluated by taking blood samples on day 1, 10, and 20 and measuring serum prolactin using a human serum prolactin ELISA kit'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Breast Milk Expression']}, 'descriptionModule': {'briefSummary': 'This study aims to determine whether a 20-day supplement with either Oat Mama Lactation Supplement, moringa, or shatavari has any impact on milk production through an increase in serum prolactin levels when compared to the placebo group. This data will be used to determine if clinical recommendations can be made for the use of the studied supplements in increasing milk supply.', 'detailedDescription': 'This study will be a double-blind randomized control trial where eligible participants will be randomized into one of four treatment groups: Oat Mama Lactation Supplement (O), moringa supplement (M), shatavari supplement (S), or control (C). All participants will receive a supplement or placebo for consumption throughout the 20-day trial period, and all participants will receive support from a lactation consultant once per week to receive appropriate guidance for increasing milk supply. 24-hour milk output will be recorded on day 1, 10, and 20 using either pre- and post-feeding weights, 24-hour pump output, or a combination of both. Additionally, blood samples will be taken on day 1, 10, and 20 and serum will be isolated for later analysis of serum prolactin levels.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Lactating women', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria: Participants in the study must:\n\n* Be struggling with diagnosed or perceived low milk supply\n* Be willing to consume a randomly assigned galactagogue or placebo supplement\n* Be willing to provide a blood sample at each lactation consult (day 1, 10, 20)\n* Be willing to provide 24-hour expressed milk volume either using pre- and post-feed weights, total pump output, or a combination of both on day 1, 10, and 20\n\nExclusion Criteria: Participants will be excluded if:\n\n* They have a history of breast reduction\n* They have a history of utilizing in vitro fertilization\n* They are not a biological female with mammary glands present for producing milk\n* They have consumed galactagogues with the intention of increasing their milk supply during the current lactation cycle\n* They are under age 18 or above age 39'}, 'identificationModule': {'nctId': 'NCT05398367', 'briefTitle': 'Galactagogue Use in Lactating Women With Low Milk Supply', 'organization': {'class': 'OTHER', 'fullName': 'Winthrop University'}, 'officialTitle': 'Effect of Single Ingredient and Blend Galactagogue Supplements on Increasing Milk Supply in Lactating Women Experiencing Diagnosed or Perceived Low Milk Supply', 'orgStudyIdInfo': {'id': 'IRB22107R'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Oat Mama Lactation Supplement', 'description': 'Participants will receive a 20 day supply of oat mama lactation supplement for consumption per the manufacturer instructions', 'interventionNames': ['Dietary Supplement: Galactagogue Supplement for Treatment of Low Milk Supply']}, {'type': 'EXPERIMENTAL', 'label': 'Moringa Supplement', 'description': 'Participants will receive a 20 day supply of moringa supplement for consumption per the manufacturer instructions', 'interventionNames': ['Dietary Supplement: Galactagogue Supplement for Treatment of Low Milk Supply']}, {'type': 'EXPERIMENTAL', 'label': 'Shatavari Supplement', 'description': 'Participants will receive a 20 day supply of shatavari supplement for consumption per the manufacturer instructions', 'interventionNames': ['Dietary Supplement: Galactagogue Supplement for Treatment of Low Milk Supply']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants will receive a 20 day supply of placebo pills containing a mixture of flour and brown sugar. Participants will consume 2 placebo pills once per day for 20 days.', 'interventionNames': ['Dietary Supplement: Galactagogue Supplement for Treatment of Low Milk Supply']}], 'interventions': [{'name': 'Galactagogue Supplement for Treatment of Low Milk Supply', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Participants will consume a commercially available dietary supplement on the market for augmentation of breast milk production in lactating women with low milk supply', 'armGroupLabels': ['Moringa Supplement', 'Oat Mama Lactation Supplement', 'Placebo', 'Shatavari Supplement']}]}, 'contactsLocationsModule': {'locations': [{'zip': '29733', 'city': 'Rock Hill', 'state': 'South Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Hope K Lima, PhD', 'role': 'CONTACT', 'email': 'limah@winthrop.edu', 'phone': '803-323-4540'}, {'name': 'Hope K Lima, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Winthrop University', 'geoPoint': {'lat': 34.92487, 'lon': -81.02508}}], 'centralContacts': [{'name': 'Hope K Lima, PhD', 'role': 'CONTACT', 'email': 'limah@winthrop.edu', 'phone': '803-323-4540'}], 'overallOfficials': [{'name': 'Hope K Lima, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Winthrop University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'There will be no sharing of individual participant data to researchers outside of the experimental team.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Winthrop University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor and Graduate Director', 'investigatorFullName': 'Hope Lima', 'investigatorAffiliation': 'Winthrop University'}}}}