Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-30 @ 3:19 AM
Study NCT ID:
NCT07303595
Status:
RECRUITING
Last Update Posted:
2025-12-26
First Post:
2025-09-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mom Multi Postnatal Supplementation Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-11-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-10', 'studyFirstSubmitDate': '2025-09-02', 'studyFirstSubmitQcDate': '2025-12-10', 'lastUpdatePostDateStruct': {'date': '2025-12-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-12-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To assess the effects of the multi-vitamin-mineral (MVM) supplement on changes in maternal Vitamin D status as compared to placebo among healthy, postpartum women.', 'timeFrame': '12 weeks', 'description': 'Changes in serum Vitamin D (25-hydroxyvitamin D (25(OH)D) from baseline to end of intervention (12 weeks)'}, {'measure': 'To assess the effects of the multi-vitamin-mineral (MVM) supplement on changes in maternal iron status as compared to placebo among healthy, postpartum women.', 'timeFrame': '12 weeks', 'description': 'Changes in Iron status (serum iron, ferritin, TIBC, transferrin) from baseline to end of intervention (12 weeks)'}, {'measure': 'To assess the effects of the multi-vitamin-mineral (MVM) supplement on changes in maternal Vitamin B12 status as compared to placebo among healthy, postpartum women.', 'timeFrame': '12 weeks', 'description': 'Changes in serum B12 from baseline to end of intervention (12 weeks)'}, {'measure': 'To assess the effects of the multi-vitamin-mineral (MVM) supplement on changes in maternal iodine status as compared to placebo among healthy, postpartum women.', 'timeFrame': '12 weeks', 'description': 'Iodine status measured as Maternal Urinary Iodine Concentrations + Creatinine at baseline and 12 weeks'}, {'measure': 'To assess the effects of the multi-vitamin-mineral (MVM) supplement on changes in maternal Omega-3 status as compared to placebo among healthy, postpartum women.', 'timeFrame': '12 weeks', 'description': 'Changes in RBC Omega-3 (Total, DHA, and EPA) from baseline to end of intervention (12 weeks)'}, {'measure': 'To assess the effects of the multi-vitamin-mineral (MVM) supplement on changes in maternal folate status as compared to placebo among healthy, postpartum women.', 'timeFrame': '12 weeks', 'description': 'Changes in folate status (RBC folate) from baseline to end of intervention (12 weeks)'}], 'secondaryOutcomes': [{'measure': 'To assess the effects of the MVM supplement on changes in maternal mental health/wellbeing questionnaire among healthy, postpartum women.', 'timeFrame': '12 weeks', 'description': 'Change in scores on WHOQOL-BREF questionnaire of maternal mental health/wellbeing outcomes from baseline to end of 12 weeks'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Postnatal', 'multivitamin dietary supplement'], 'conditions': ['Postnatal Care']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to learn if a vitamin and mineral supplement designed specifically for women after childbirth can improve their nutrition and health in women who are pregnant or have recently given birth (within 6 weeks).\n\nThe main question it aims to answer is:\n\nCan a postpartum-specific vitamin and mineral supplement help improve nutritional status and health outcomes in women after giving birth?\n\nResearchers will compare women who take the new postpartum vitamin and mineral supplement to women who take a placebo (fake pills without active ingredients) to see if the supplement improves their nutritional health.\n\nParticipants will:\n\nAttend 2 visits at University of Georgia (1-1.5 hours each) over 12 weeks Participate in 2 phone calls between visits Stop taking other vitamin/mineral supplements during the study Have blood drawn to test vitamin and mineral levels Provide urine samples and breastmilk samples if breastfeeding (optional) Have height, weight, and skin color measured Complete questionnaires about health, pregnancy, and mental wellness Answer questions about daily food and drink intake Take either the study supplement or placebo daily'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion criteria:\n\n* Healthy, postpartum women (\\~4 weeks \\[± 2 weeks\\]) with infants born term and singleton\n* Not pregnant during the study period\n* Able to understand (written and spoken) English or Spanish.\n\nExclusion criteria:\n\n* Cardiometabolic disease\n* Past pregnancy complications (gestational diabetes, hypertension)\n* malabsorption syndromes (IBS, IBD, Crohn's, Colitis, Celiac)\n* Caily use of medications which may affect nutrient absorption\n* chronic alcohol use (\\> 4 alcoholic drinks/day)\n* those prescribed postnatal MVM supplements by their physician\n* unwilling to discontinue dietary supplementation containing any of the active components in the study product over the study period\n* Women should not have an allergy or intolerance to active or inactive product ingredients."}, 'identificationModule': {'nctId': 'NCT07303595', 'briefTitle': 'Mom Multi Postnatal Supplementation Trial', 'organization': {'class': 'INDUSTRY', 'fullName': 'Perelel Inc.'}, 'officialTitle': 'Effect of a Postpartum Multivitamin-Mineral Supplement on Maternal Nutrient Status and Wellbeing', 'orgStudyIdInfo': {'id': 'PROJECT00012011'}, 'secondaryIdInfos': [{'id': 'Sponsor', 'type': 'OTHER', 'domain': 'Perelel Health'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Multivitamin supplement pack', 'description': '4 capsules and 1 softgel', 'interventionNames': ['Dietary Supplement: Perelel Mom Multi']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': '4 capsules + 1 softgel', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'Perelel Mom Multi', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Daily Perelel postnatal multivitamin supplement throughout intervention', 'armGroupLabels': ['Multivitamin supplement pack']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Daily placebo capsules throughout intervention', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30606', 'city': 'Athens', 'state': 'Georgia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Sina Gallo, PHD', 'role': 'CONTACT', 'email': 'ctru@uga.edu', 'phone': '706-713-2721'}], 'facility': 'UGA Clinical & Translational Unit', 'geoPoint': {'lat': 33.96095, 'lon': -83.37794}}], 'centralContacts': [{'name': 'Sina Gallo, PhD, MSc, RD', 'role': 'CONTACT', 'email': 'ctru@uga.edu', 'phone': '706-542-4847'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Perelel Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'University of Georgia', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}