Ignite Creation Date:
2025-12-24 @ 2:28 PM
Ignite Modification Date:
2026-03-15 @ 4:25 AM
Study NCT ID:
NCT02032459
Status:
COMPLETED
Last Update Posted:
2014-01-10
First Post:
2013-12-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vitamin D and Pregnancy: Camden Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D047928', 'term': 'Premature Birth'}, {'id': 'D005317', 'term': 'Fetal Growth Retardation'}, {'id': 'D011225', 'term': 'Pre-Eclampsia'}, {'id': 'D016640', 'term': 'Diabetes, Gestational'}], 'ancestors': [{'id': 'D007752', 'term': 'Obstetric Labor, Premature'}, {'id': 'D007744', 'term': 'Obstetric Labor Complications'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D005315', 'term': 'Fetal Diseases'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D006130', 'term': 'Growth Disorders'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D046110', 'term': 'Hypertension, Pregnancy-Induced'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood and urine collection: Fasting (\\>8 h) maternal blood samples were collected at entry to care and week 28 of gestation. Blood specimens were also collected at 1-hour of the 50g glucose challenge test. Fasting blood samples collected at each visit were immediately refrigerated and centrifuged at 4oC. Plasma and serum were preserved from each patient (at -70oC) until assayed. 20 ml of urine was collected at entry to care and week 28 in metal free plastic containers and stored at -70oC.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1141}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-01', 'lastUpdateSubmitDate': '2014-01-08', 'studyFirstSubmitDate': '2013-12-19', 'studyFirstSubmitQcDate': '2014-01-08', 'lastUpdatePostDateStruct': {'date': '2014-01-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-01-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Relationship of Vitamin D to maternal diet, etc.', 'timeFrame': 'Up to 5 years', 'description': 'To describe the relationship of maternal vitamin D status to maternal diet and supplement use, season of year, ethnicity, overweight/obesity, and other maternal characteristics.'}], 'primaryOutcomes': [{'measure': 'Maternal Vitamin D Status', 'timeFrame': 'Up to 5 years', 'description': 'Our primary objective is to determine the prognostic importance of maternal vitamin D status for birth weight, gestation duration and poor pregnancy outcomes (low birth weight, preterm delivery, and fetal growth restriction).'}], 'secondaryOutcomes': [{'measure': 'Vitamin D Status in relations to pregnancy complications', 'timeFrame': 'Up to 5 years', 'description': 'To determine the relation of maternal vitamin D status to important complications of pregnancy (gestational diabetes and pre-eclampsia).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Pregnancy', 'Minority Women', 'Preterm delivery', 'Fetal growth restriction', 'Preeclampsia', 'Gestational Diabetes', 'Vitamin D'], 'conditions': ['Reproductive Effects', 'Pregnancy']}, 'referencesModule': {'references': [{'pmid': '23885046', 'type': 'RESULT', 'citation': 'Scholl TO, Chen X, Stein TP. Vitamin D, secondary hyperparathyroidism, and preeclampsia. Am J Clin Nutr. 2013 Sep;98(3):787-93. doi: 10.3945/ajcn.112.055871. Epub 2013 Jul 24.'}, {'pmid': '22606373', 'type': 'RESULT', 'citation': 'Scholl TO, Chen X, Stein P. Maternal vitamin D status and delivery by cesarean. Nutrients. 2012 Apr;4(4):319-30. doi: 10.3390/nu4040319. Epub 2012 Apr 20.'}, {'pmid': '19008055', 'type': 'RESULT', 'citation': 'Scholl TO, Chen X. Vitamin D intake during pregnancy: association with maternal characteristics and infant birth weight. Early Hum Dev. 2009 Apr;85(4):231-4. doi: 10.1016/j.earlhumdev.2008.10.006. Epub 2008 Nov 12.'}, {'pmid': '24500145', 'type': 'DERIVED', 'citation': 'Scholl TO, Chen X, Stein TP. Maternal calcium metabolic stress and fetal growth. Am J Clin Nutr. 2014 Apr;99(4):918-25. doi: 10.3945/ajcn.113.076034. Epub 2014 Feb 5.'}]}, 'descriptionModule': {'briefSummary': 'Vitamin D is present in food either naturally or by fortification and included in nutritional supplements. It is also synthesized photochemically by the skin from ultraviolet B radiation. Vitamin D synthesis varies by season and with latitude as well as according to intensity of skin pigmentation. Recent research in the United States found lower circulating levels of 25 (OH) D, the primary indicator of vitamin D status, among minority women who were either pregnant or in their reproductive years. The extent to which maternal vitamin D has an influence on the course and outcome of human pregnancy remains to be more completely studied. We propose to use the HPLC method to assay cholecaliferol (vitamin D3) and ergocalciferol (vitamin D2) to assess maternal vitamin D status. This will be accomplished by analyzing existing fasting samples and data derived from the 2001-2006 cohort (N=1141) of young, low income minority gravidae from Camden, New Jersey to determine:\n\n1. The prognostic importance of maternal vitamin D status for birth weight, gestation duration and poor pregnancy outcomes (low birth weight, preterm delivery, fetal growth restriction).\n2. The relation of maternal vitamin D status to important complications of pregnancy (gestational diabetes and pre-eclampsia).\n3. The relationship of maternal vitamin D status to maternal diet and supplement use, season of year, ethnicity, overweight/obesity, and other maternal characteristics.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This study is conducted from previously collected data (N=1141) from the Camden Study of low income gravidae and minority gravidae (White, African-American and Hispanic) living in the northeastern United States (New Jersey).', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria: Positive pregnancy test, informed consent, gestation at entry ≤20 weeks\n\nExclusion Criteria: Women with serious non-obstetric problems including lupus, type 1 or type 2 diabetes, seizure disorders, malignancies, acute or chronic liver or renal diseases, drug or alcohol abuse and psychiatric problems were not eligible for participation.'}, 'identificationModule': {'nctId': 'NCT02032459', 'briefTitle': 'Vitamin D and Pregnancy: Camden Study', 'organization': {'class': 'OTHER', 'fullName': 'Rowan University'}, 'officialTitle': 'Vitamin D Status in Pregnant Women', 'orgStudyIdInfo': {'id': '0320070046'}, 'secondaryIdInfos': [{'id': '5R21HD058128', 'link': 'https://reporter.nih.gov/quickSearch/5R21HD058128', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Minority Women', 'description': 'Study data pulled from already collected data (N=1141 from the Camden Study of low income gravidae and minority gravidae (White, African-American and Hispanic) living in the northeastern United States (New Jersey).'}]}, 'contactsLocationsModule': {'locations': [{'zip': '08084', 'city': 'Stratford', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Rowan University', 'geoPoint': {'lat': 39.82678, 'lon': -75.01545}}], 'overallOfficials': [{'name': 'Theresa O Scholl, PhD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rowan University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rowan University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, Obstetrics and Gynecology', 'investigatorFullName': 'Theresa Scholl', 'investigatorAffiliation': 'Rowan University'}}}}