Ignite Creation Date:
2025-12-24 @ 10:38 PM
Ignite Modification Date:
2026-01-01 @ 7:42 AM
Study NCT ID:
NCT01060735
Status:
UNKNOWN
Last Update Posted:
2011-07-22
First Post:
2010-01-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vitamin D Supplementation During Pregnancy and Bone Status in Children at Birth and at One Year of Age
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D014807', 'term': 'Vitamin D'}], 'ancestors': [{'id': 'D012632', 'term': 'Secosteroids'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2010-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-07', 'completionDateStruct': {'date': '2013-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-07-21', 'studyFirstSubmitDate': '2010-01-31', 'studyFirstSubmitQcDate': '2010-02-01', 'lastUpdatePostDateStruct': {'date': '2011-07-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-02-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bone status in offspring at the age of one year as assessed by tibial and radius quantitative ultrasound (QUS).', 'timeFrame': 'Bone status in offsprings, assessed at the age of one year'}], 'secondaryOutcomes': [{'measure': 'Vitamin D status of mothers.', 'timeFrame': 'At the start of intervention, at delivery and at the age of one year'}, {'measure': 'Maternal health status.', 'timeFrame': 'At the start of intervention, at delivery and at the age of one year'}, {'measure': "Infants' growth.", 'timeFrame': 'At the start of intervention, at delivery and at the age of one year'}, {'measure': 'Vitamin D status in infants.', 'timeFrame': 'At the start of intervention, at delivery and at the age of one year'}, {'measure': 'Safety of vitamin D supplementation doses.', 'timeFrame': 'At the start of intervention, at delivery and at the age of one year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Vitamin D', 'pregnancy', 'children', 'bone', 'quantitative ultrasound', 'Healthy pregnant women'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'Vitamin D deficiency is frequently reported in pregnant women despite recommendation of daily vitamin D supplementation of 400IU/d. Recent studies have shown that in the absence of sun exposure these doses are seldom able to achieve 25(OH)D optimal serum levels.\n\nWe hypothesize that larger doses of vitamin D are needed to be supplemented to all women during pregnancy. We hypothesize that this may have advantageous effects on maternal vitamin D and bone reserve as well on offspring vitamin D and bone status at birth and possible further on.\n\nThe aim of the present study is to compare vitamin D and bone status of infants born to mothers supplemented with 400IU/d (present recommendations) and 2000IU/d vitamin D during the third trimester of pregnancy.', 'detailedDescription': 'This is a prospective randomized controlled study.\n\n120 pregnant women will be recruited at 27 weeks gestation and randomized into two treatment groups; 400IU/d or 2000IU/d vitamin D supplementation from 27 weeks until delivery.\n\n25-hydroxyvitamin D (25OHD), parathyroid hormone (PTH), urinary calcium/creatinine and serum calcium and alkaline phosphatase (ALP) levels will be assessed in mothers at 27 weeks and at delivery.\n\n25OHD, calcium and ALP levels, and urinary calcium/creatinine will be evaluated in offspring at birth and at one year age.\n\nVitamin D and calcium intake and sun exposure will be evaluated in mothers and offsprings.\n\nQuantitative ultrasound (QUS) measurement of tibia and radius will be performed to newborns and at the age of one year.\n\nBone status of newborns at birth and at one year age in children will be compared between the 2 groups.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy pregnant women aged 20 to 40 years, of any parity status.\n* Signed informed consent\n\nExclusion Criteria:\n\n* Presence of diseases known to affect vitamin D status such as malabsorption states, liver and renal disorders, primary and tertiary hyperparathyroidism, granulomatous disorders\n* Treatment with medications known to affect vitamin D status such as anticonvulsivants, glucocorticoids, antirejection medication and retroviral agents'}, 'identificationModule': {'nctId': 'NCT01060735', 'briefTitle': 'Vitamin D Supplementation During Pregnancy and Bone Status in Children at Birth and at One Year of Age', 'organization': {'class': 'OTHER', 'fullName': 'Rabin Medical Center'}, 'officialTitle': 'The Effect of Different Doses of Vitamin D Supplementation During Pregnancy on Bone and Vitamin D Status in Children at Birth and at One Year Age', 'orgStudyIdInfo': {'id': 'rmc005437ctil'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Larger doses of vitamin D supplementation', 'description': 'The subjects enrolled in this arm will be supplemented during the third trimester of pregnancy with 2000IU vitamin D per day', 'interventionNames': ['Dietary Supplement: Vitamin D']}, {'type': 'NO_INTERVENTION', 'label': 'Conventional vitamin D supplementation', 'description': 'Regular supplementation during pregnancy with 400IU vitamin D'}], 'interventions': [{'name': 'Vitamin D', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Vitamin D 2000iu/ day from the 27 week of pregnancy up to delivery', 'armGroupLabels': ['Larger doses of vitamin D supplementation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '49202', 'city': 'Petah Tikva', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Raanan Shamir, Professor', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Eran Adar, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Moshe Hod, Professor', 'role': 'SUB_INVESTIGATOR'}], 'facility': "Schneider Children's Medical Center of Israel", 'geoPoint': {'lat': 32.08707, 'lon': 34.88747}}], 'centralContacts': [{'name': 'Corina Hartman, MD', 'role': 'CONTACT', 'email': 'corinah@clalit.org.il', 'phone': '972-3-9253674'}, {'name': 'Raanan Shamir, Professor', 'role': 'CONTACT', 'email': 'raanans@clalit.org.il', 'phone': '972-3-9253673'}], 'overallOfficials': [{'name': 'Corina Hartman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rabin Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rabin Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Corina Hartman, MD', 'oldOrganization': 'Rabin Medical Center'}}}}