Ignite Creation Date:
2025-12-25 @ 1:14 AM
Ignite Modification Date:
2026-02-25 @ 10:04 PM
Study NCT ID:
NCT03037593
Status:
WITHDRAWN
Last Update Posted:
2019-11-01
First Post:
2017-01-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
High Dose Cholecalciferol to Reduce the Incidence of Gestational Diabetes in High Risk Pregnant Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016640', 'term': 'Diabetes, Gestational'}], 'ancestors': [{'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'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'}]}, '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': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'This will be a randomized single-center study with a target study group of 300 women. Women will be followed from enrollment through the remainder of their pregnancy'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Failure to recruit adequate patients', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2017-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2020-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-10-30', 'studyFirstSubmitDate': '2017-01-27', 'studyFirstSubmitQcDate': '2017-01-30', 'lastUpdatePostDateStruct': {'date': '2019-11-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-01-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'incidence of gestational diabetes', 'timeFrame': 'Baseline to Delivery of child', 'description': 'effect of increased vitamin D supplementation (4000 IU vitamin D3 +prenatal vitamin) on the incidence of gestational diabetes compared to a standard prenatal vitamin among pregnant women at high risk for gestational diabetes.'}], 'secondaryOutcomes': [{'measure': 'Prescription for insulin or oral hypoglycemic agents', 'timeFrame': 'Baseline to Delivery of child', 'description': 'Prescription for insulin or oral hypoglycemic agents'}, {'measure': 'Mode of delivery', 'timeFrame': 'Delivery of child', 'description': 'Natural or C-Section'}, {'measure': 'Birth weight', 'timeFrame': 'Delivery of Child', 'description': 'Weight in Kg'}, {'measure': 'Apgar score', 'timeFrame': 'Birth of child to 5 minutes', 'description': '\\<7 at 5 minutes'}, {'measure': 'Shoulder Dystocia', 'timeFrame': 'Birth of child'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pregnancy', 'Gestational Diabetes'], 'conditions': ['Gestational Diabetes']}, 'descriptionModule': {'briefSummary': 'Demonstrate dose-dependent relationship between vitamin D supplementation and rates of gestational diabetes.', 'detailedDescription': 'Determine the effect of increased vitamin D supplementation (4000 IU vitamin D3 +prenatal vitamin) on the incidence of gestational diabetes compared to a standard prenatal vitamin among pregnant women at high risk for gestational diabetes.\n\nExplore the effect of increased vitamin D supplementation (4000 IU daily + prenatal vitamin), compared to a standard prenatal vitamin, on glycemic control, need for oral hypoglycemic agents and/or insulin, and delivery outcomes among the subset of women who develop gestational diabetes.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Women who are currently pregnant and receiving prenatal care at the Women's Health Specialists Clinic (University of Minnesota Physicians) from either MD/DO or CNM providers\n2. Subject established prenatal care no later than the completed 12th week of gestation (12 6/7 weeks)\n3. Subject possesses as least one of the following characteristics:\n\n 1. BMI greater than or equal to 30 kg/m2\n 2. History of gestational diabetes in a prior pregnancy\n 3. History of infant with birth weight of 4500g or greater\n4. Subject is capable of giving informed consent\n\nExclusion Criteria:\n\n1. Age less than 18 years\n2. Multiple gestation pregnancies (twins, triplets or greater multiples)\n3. Vitamin D deficiency (defined as less than 20 ng/mL)\n4. Preexisting diabetes mellitus defined as either:\n\n 1. pre-existing diagnosis prior to current pregnancy\n 2. failure of three-hour glucose tolerance test in first trimester of pregnancy"}, 'identificationModule': {'nctId': 'NCT03037593', 'briefTitle': 'High Dose Cholecalciferol to Reduce the Incidence of Gestational Diabetes in High Risk Pregnant Women', 'organization': {'class': 'OTHER', 'fullName': 'University of Minnesota'}, 'officialTitle': 'A Randomized Single-Center Study of the Effects of High-Dose Cholecalciferol to Reduce the Incidence of Gestational Diabetes in High-Risk Pregnant Women', 'orgStudyIdInfo': {'id': '1611M98781'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': '4000 IU vitamin D3 +prenatal vitamin', 'interventionNames': ['Drug: 4000 IU vitamin D3']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'standard prenatal vitamin'}], 'interventions': [{'name': '4000 IU vitamin D3', 'type': 'DRUG', 'otherNames': ['cholecalciferol'], 'description': 'vitamin D supplementation (4000 IU vitamin D3 +prenatal vitamin', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55455', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'University of Minnesota Medical Center', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}], 'overallOfficials': [{'name': 'Samantha Hoffman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Minnesota'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Minnesota', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}