Ignite Creation Date:
2025-12-24 @ 5:49 PM
Ignite Modification Date:
2026-01-22 @ 11:33 AM
Study NCT ID:
NCT02297568
Status:
COMPLETED
Last Update Posted:
2020-10-23
First Post:
2014-11-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vitamin D Supplementation During Lactation
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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-07', 'completionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-21', 'studyFirstSubmitDate': '2014-11-10', 'studyFirstSubmitQcDate': '2014-11-20', 'lastUpdatePostDateStruct': {'date': '2020-10-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-11-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison serum 25OHD levels from breastfed infants', 'timeFrame': '6 weeks after delivery'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Breast-fed infant', 'vitamin D supplementation', 'Lactation'], 'conditions': ['Deficiency, Vitamin D']}, 'descriptionModule': {'briefSummary': 'This randomized, placebo-controlled trial in Thai pregnancy is conducted. The study aims to determine whether vitamin D3 1,800 IU/d supplementation in lactating mother improves vitamin D status of breastfed infant.', 'detailedDescription': 'Vitamin D deficiency in pregnancy increases risk of gestational diabetes mellitus, pre-eclampsia, preterm birth, low birth weight and cesarean section. To against these adverse events, vitamin D supplementation in pregnancy and lactation is recommended, but dose ranges are varied. Then, this study is carried out in lactating mothers and their breastfed infants with maternal 25 Hydroxy-vitamin D (25OHD) levels of 10-30 ng/ml in third trimester. Subjects are divided into 2 groups, one is randomly assigned to 1,800 IU/d compared with maternal and infant controls receiving placebo. Maternal serum 25OHD and milk VitD will be measured by LC-MS/MS during lactation, and on cord blood at 6 weeks breastfed infants. This study is submitted for ethical consideration by relevant Ethics committee.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pregnant Thai women and intends to deliver at Rajavithi Hospital\n* Insufficient Vitamin D levels (25(OH)D \\< 30ng/ml)\n* Gestational age at birth and no complications\n\nExclusion Criteria:\n\n* Age \\< 18 years old\n* Unintended to deliver at Rajavithi Hospital\n* Insufficient Vitamin D levels (25(OH)D \\< 10ng/ml)'}, 'identificationModule': {'nctId': 'NCT02297568', 'briefTitle': 'Vitamin D Supplementation During Lactation', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Department of Medical Services Ministry of Public Health of Thailand'}, 'officialTitle': 'Randomized Control Trial of Vitamin D Supplementation During Lactation on Vitamin D in Maternal Milk', 'orgStudyIdInfo': {'id': 'RJVITD001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Calciferol,1800 IU/d supplement', 'description': 'The lactating mothers and their breastfed infants with maternal 25 Hydroxy-vitamin D (25OHD) levels of 10-30 ng/ml in third trimester were randomly assigned to 1,800 IU/d .', 'interventionNames': ['Drug: Calciferol']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'The lactating mothers and their breastfed infants with maternal 25 Hydroxy-vitamin D (25OHD) levels of 10-30 ng/ml in third trimester were randomly assigned to receive placebo.', 'interventionNames': ['Drug: placebo']}], 'interventions': [{'name': 'Calciferol', 'type': 'DRUG', 'otherNames': ['Vitamin D3'], 'description': 'Comparison 25OHD levels between calciferol and placebo', 'armGroupLabels': ['Calciferol,1800 IU/d supplement']}, {'name': 'placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10400', 'city': 'Bangkok', 'country': 'Thailand', 'facility': 'Rajavithi Hospital', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}], 'overallOfficials': [{'name': 'Sathit Niramitmahapanya, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Medical Services Ministry of Public Health of Thailand'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Department of Medical Services Ministry of Public Health of Thailand', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Queen Sirikit National Institute of Child Health', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}