Ignite Creation Date:
2025-12-24 @ 7:38 PM
Ignite Modification Date:
2025-12-29 @ 1:28 PM
Study NCT ID:
NCT01630603
Status:
UNKNOWN
Last Update Posted:
2013-02-12
First Post:
2012-06-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Maternal Vitamin D Status and Neonatal Bone Strength
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-06', 'lastUpdateSubmitDate': '2013-02-11', 'studyFirstSubmitDate': '2012-06-18', 'studyFirstSubmitQcDate': '2012-06-27', 'lastUpdatePostDateStruct': {'date': '2013-02-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-06-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bone speed of sound and maternal vitamin D levels', 'timeFrame': 'first tow days of life'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Maternal Vitamin D Status', 'Neonatal Bone Quantitative Ultrasound Measurements']}, 'descriptionModule': {'briefSummary': 'Objectives:\n\n1. To determine the incidence of vitamin D deficiency among Israeli pregnant women\n2. To access whether maternal vitamin D status affects infant bone strength.\n\nMethods:\n\n1. Vitamin D levels -in cord blood and maternal blood\n2. The mother will fill a demographic and nutritional questionnaire\n\n The Infants:\n3. Growth assessment of the infants: weight length and head circumference\n4. Bone strength measurement by Quantitative Ultrasound (Sunlight Omnisense 7000/8000TM)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Inborn mother infants pairs', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* mother-baby pairs,\n* birth week 35-42.\n* Jewish and Arab women that read and understand Hebrew.\n\nExclusion Criteria:\n\n* large neonatal congenital defects.'}, 'identificationModule': {'nctId': 'NCT01630603', 'acronym': 'Vitamin D', 'briefTitle': 'Maternal Vitamin D Status and Neonatal Bone Strength', 'organization': {'class': 'OTHER', 'fullName': 'Meir Medical Center'}, 'officialTitle': 'Maternal Vitamin D Status and Neonatal Bone Strength', 'orgStudyIdInfo': {'id': 'MMC14-12'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'mother infants pairs'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kfar Saba', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Ita Litmanovitz Litmanovitz, MD', 'role': 'CONTACT'}], 'facility': 'Meir Medical Center', 'geoPoint': {'lat': 32.175, 'lon': 34.90694}}, {'city': 'Kfar Saba', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Ita Litmanovits', 'role': 'CONTACT', 'email': 'litmani@clalit.org.il', 'phone': '09-7471154'}, {'name': 'Ita Litmanovitz, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Meir Medical Center', 'geoPoint': {'lat': 32.175, 'lon': 34.90694}}, {'city': 'Kfar Saba', 'status': 'NOT_YET_RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Ita Litmanovich, MD', 'role': 'CONTACT'}, {'name': 'Ita Litmanovich, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Neonatal department Meir Medical Center', 'geoPoint': {'lat': 32.175, 'lon': 34.90694}}], 'centralContacts': [{'name': 'Ita Litmanovich, MD', 'role': 'CONTACT', 'email': 'litmani@clalit.org.il', 'phone': '09-7471554'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Meir Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}