Ignite Creation Date:
2025-12-24 @ 6:35 PM
Ignite Modification Date:
2025-12-25 @ 4:05 PM
Study NCT ID:
NCT01506557
Status:
COMPLETED
Last Update Posted:
2013-07-23
First Post:
2011-05-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Vitamin D Supplementation of Lactating Mothers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014808', 'term': 'Vitamin D Deficiency'}, {'id': 'D001942', 'term': 'Breast Feeding'}], 'ancestors': [{'id': 'D001361', 'term': 'Avitaminosis'}, {'id': 'D003677', 'term': 'Deficiency Diseases'}, {'id': 'D044342', 'term': 'Malnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D005247', 'term': 'Feeding Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002762', 'term': 'Cholecalciferol'}], 'ancestors': [{'id': 'D002782', 'term': 'Cholestenes'}, {'id': 'D002776', 'term': 'Cholestanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013261', 'term': 'Sterols'}, {'id': 'D014807', 'term': 'Vitamin D'}, {'id': 'D012632', 'term': 'Secosteroids'}, {'id': 'D008563', 'term': 'Membrane Lipids'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 174}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-07', 'completionDateStruct': {'date': '2012-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-07-22', 'studyFirstSubmitDate': '2011-05-11', 'studyFirstSubmitQcDate': '2012-01-09', 'lastUpdatePostDateStruct': {'date': '2013-07-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-01-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'serum 25-hydroxyvitamin D concentration,', 'timeFrame': '3 time poits up to 6 months (0-3-6 months)'}], 'secondaryOutcomes': [{'measure': 'body composition measured by dual x-ray densitometry', 'timeFrame': '3 time points up to 6 months (0-3-6months)'}, {'measure': 'serum calcium', 'timeFrame': '2 time poits up to 6 months ( 3-6 months)'}, {'measure': 'calciuria (Urinary calcium and creatinine - UCa/crea)', 'timeFrame': '2 time poits up to 6 months ( 3-6 months)'}, {'measure': 'iPTH', 'timeFrame': '3 time poits up to 6 months (0-3-6 months)'}, {'measure': 'Prevalence of vitamin D deficiency (25OHD<20ng/ml)', 'timeFrame': '3 time poits up to 6 months (0-3-6 months)'}, {'measure': 'Prevalence of vitamin D sufficiency (25OHD>30ng/ml)', 'timeFrame': '3 time poits up to 6 months (0-3-6 months)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['vitamin D', 'vitamin D deficiency', 'breastfeeding', 'body composition', 'bone mineral content'], 'conditions': ['Vitamin D Deficiency']}, 'referencesModule': {'references': [{'pmid': '25232839', 'type': 'DERIVED', 'citation': 'Czech-Kowalska J, Latka-Grot J, Bulsiewicz D, Jaworski M, Pludowski P, Wygledowska G, Chazan B, Pawlus B, Zochowska A, Borszewska-Kornacka MK, Karczmarewicz E, Czekuc-Kryskiewicz E, Dobrzanska A. Impact of vitamin D supplementation during lactation on vitamin D status and body composition of mother-infant pairs: a MAVID randomized controlled trial. PLoS One. 2014 Sep 18;9(9):e107708. doi: 10.1371/journal.pone.0107708. eCollection 2014.'}]}, 'descriptionModule': {'briefSummary': "The investigators would like to test the hypothesis that maternal vitamin D supplementation during lactation in dose 1200IU/d (400IU from multivitamins + 800 IU cholecalciferol) is more effective than 400IU/d (400IU from multivitamins + placebo)to built appropriate maternal vitamin D status and could be beneficial for maternal and infants bone mineralization and body composition (proper proportion of muscle and fat tissues in body weight) and is safe for both.\n\nThe investigators also want to confirm that vitamin D supplementation of exclusively breastfed infants in dose 400IU/d is adequate to build appropriate vitamin D status independently of mother's vitamin D supplementation up to 1200 ID/d.\n\nAdditionally the investigators hypothesize that because of changes in lifestyle there will be no substantial seasonal differences in vitamin D status of pregnant women at the delivery and their newborn infants."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy women without major medical problem delivered at term and planning breastfeeding for next six months delivering term, single, infants with birth weight appropriate for gestational age without major health problem\n\nExclusion Criteria:\n\n* Maternal endocrine disorders, disturbed calcium- phosphorus homeostasis, anticonvulsant treatment.\n* Infants renal, hepatic insufficiency, endocrine disorders, congenital malformations, anticonvulsant treatment.'}, 'identificationModule': {'nctId': 'NCT01506557', 'acronym': 'MAVID', 'briefTitle': 'Vitamin D Supplementation of Lactating Mothers', 'organization': {'class': 'OTHER', 'fullName': "Children's Memorial Health Institute, Poland"}, 'officialTitle': 'Effect of Vitamin D Supplementation During Lactation on Vitamin D Status, Bone Mineralisation and Body Composition of Mother and Their Exclusively Breastfed Infants.', 'orgStudyIdInfo': {'id': '763/10'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'choecalciferol', 'interventionNames': ['Dietary Supplement: cholecalciferol']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'interventionNames': ['Dietary Supplement: placebo']}], 'interventions': [{'name': 'cholecalciferol', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['vit D'], 'description': 'dose 800 IU/day for 6 month', 'armGroupLabels': ['choecalciferol']}, {'name': 'placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'oil capsules', 'armGroupLabels': ['placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '05-400', 'city': 'Otwock', 'state': 'Warsaw', 'country': 'Poland', 'facility': 'Public Hospital', 'geoPoint': {'lat': 52.10577, 'lon': 21.26129}}, {'zip': '00-315', 'city': 'Warsaw', 'country': 'Poland', 'facility': 'Anna Mazowiecka Hospital, Warsaw Medical University', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'zip': '02-544', 'city': 'Warsaw', 'country': 'Poland', 'facility': 'Gynecological and Obstetric Hospital', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'zip': '04-730', 'city': 'Warsaw', 'country': 'Poland', 'facility': "The Children's Memorial Health Institute", 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'zip': '04-749', 'city': 'Warsaw', 'country': 'Poland', 'facility': 'Międzyleski Hospital,', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}], 'overallOfficials': [{'name': 'Justyna Czech-Kowalska, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "The Children's Memorial Health Institute"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Memorial Health Institute, Poland", 'class': 'OTHER'}, 'collaborators': [{'name': 'Nutricia Research Fundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Deputy Head of Neonatology and Intensive Care, MD, PhD', 'investigatorFullName': 'Justyna Czech-Kowalska', 'investigatorAffiliation': "Children's Memorial Health Institute, Poland"}}}}