Ignite Creation Date:
2025-12-24 @ 4:57 PM
Ignite Modification Date:
2026-02-24 @ 1:15 AM
Study NCT ID:
NCT03101150
Status:
COMPLETED
Last Update Posted:
2018-11-02
First Post:
2017-03-21
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effect of Vitamin D3 Supplementation in Pregnancy on Risk of Pre-eclampsia
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014808', 'term': 'Vitamin D Deficiency'}, {'id': 'D011225', 'term': 'Pre-Eclampsia'}], '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': 'D046110', 'term': 'Hypertension, Pregnancy-Induced'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital 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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'amali@kfmc.med.sa', 'phone': '00966539417217', 'title': 'Consultant Obstetritian and Gynecologist', 'organization': 'King Fahd Medical City'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': '400 IU', 'description': 'Materna tablet once daily orally from 14 weeks of pregnancy til delivery.', 'otherNumAtRisk': 86, 'otherNumAffected': 0, 'seriousNumAtRisk': 86, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': '4000 IU', 'description': 'Vidrop vitamin D 40 drops daily orally from 14 weeks of pregnancy till delivery.', 'otherNumAtRisk': 93, 'otherNumAffected': 0, 'seriousNumAtRisk': 93, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Pre-eclampsia in Both Arms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '400 IU', 'description': 'Materna tablet once daily orally from 14 weeks of pregnancy til delivery.'}, {'id': 'OG001', 'title': '4000 IU', 'description': 'Vidrop vitamin D 40 drops daily orally from 14 weeks of pregnancy till delivery.'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.163', 'ciLowerLimit': '0.02', 'ciUpperLimit': '1.32', 'groupDescription': 'Eligible and consented study subjects were randomized according to permuted block design scheme to be allocated in 400 IU arm and 4000 IU arm.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'A sample size of minimum 152 was calculated to be able to determine incidence of preeclampsia that is in the range of 8-17% with 80% power assuming an alpha of 5%.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From 20 weeks of pregnancy till event of pre-eclampsia seen, whichever came first, assessed up to 32 weeks.', 'description': 'Occurrence of pre-eclampsia or not in all patients irrespective of Vitamin D dose.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Vitamin D Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '400 IU', 'description': 'Materna tablet once daily orally from 14 weeks of pregnancy til delivery.'}, {'id': 'OG001', 'title': '4000 IU', 'description': 'Vidrop vitamin D 40 drops daily orally from 14 weeks of pregnancy till delivery.'}], 'classes': [{'categories': [{'measurements': [{'value': '35.3', 'spread': '20.7', 'groupId': 'OG000'}, {'value': '72.3', 'spread': '30.9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'At 36th week of pregnancy', 'description': 'Level of Improvement in Vitamin D status in both arms', 'unitOfMeasure': 'nmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Out of 86 participants randomized for the arm of 400 IU, 3 had miscarriage and 2 lost to follow. So 81 participants were analyzed.\n\nOut of 93 participants randomized for the arm of 4000 IU, 6 had miscarriage and 4 lost to follow. So 83 were analyzed in that arm.'}, {'type': 'SECONDARY', 'title': 'Number of Patients With Intrauterine Growth Retardation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '400 IU', 'description': 'Materna tablet once daily orally from 14 weeks of pregnancy til delivery.'}, {'id': 'OG001', 'title': '4000 IU', 'description': 'Vidrop vitamin D 40 drops daily orally from 14 weeks of pregnancy till delivery.'}], 'classes': [{'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.02', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.43', 'ciLowerLimit': '0.19', 'ciUpperLimit': '0.94', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At delivery', 'description': 'Patients having fetus with retardation of growth in both arms.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '400 IU', 'description': 'Materna tablet once daily orally from 14 weeks of pregnancy til delivery.'}, {'id': 'FG001', 'title': '4000 IU', 'description': 'Vidrop vitamin D 40 drops daily orally from 14 weeks of pregnancy till delivery.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '86'}, {'groupId': 'FG001', 'numSubjects': '93'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '81'}, {'groupId': 'FG001', 'numSubjects': '83'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '10'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Miscarriage', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '6'}]}]}], 'preAssignmentDetails': '416 participants were screened. 192 did not meet eligibility criteria. 38 refused to participate and 7 turned out to be ectopic pregnancy.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'BG000'}, {'value': '93', 'groupId': 'BG001'}, {'value': '179', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': '400 IU Vitamin D3', 'description': '400IU vitamin D3 contained in antenatal multivitamin once daily by mouth starting from 14 weeks of pregnancy till delivery.\n\n400 IU Vitamin D3: Antenatal multivitamin'}, {'id': 'BG001', 'title': '4000 IU Vitamin D3', 'description': '4000 IU Vitamin D3 drops once daily by mouth starting from 14 weeks of pregnancy till delivery.\n\n4000 IU Vitamin D3: 4000 IU Vitamin D3 (cholecalciferol) daily = 40 drops daily'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '29.3', 'spread': '5.3', 'groupId': 'BG000'}, {'value': '29.4', 'spread': '4.8', 'groupId': 'BG001'}, {'value': '29.3', 'spread': '5.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '86', 'groupId': 'BG000'}, {'value': '93', 'groupId': 'BG001'}, {'value': '179', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Saudi Arabia', 'categories': [{'measurements': [{'value': '80', 'groupId': 'BG000'}, {'value': '80', 'groupId': 'BG001'}, {'value': '160', 'groupId': 'BG002'}]}]}, {'title': 'India', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}, {'title': 'Philippines', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}, {'title': 'Africa', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Body Mass Index (BMI)', 'classes': [{'categories': [{'measurements': [{'value': '28.8', 'spread': '7.3', 'groupId': 'BG000'}, {'value': '28.1', 'spread': '7.2', 'groupId': 'BG001'}, {'value': '28.4', 'spread': '7.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Kg/m2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Primiparity', 'classes': [{'categories': [{'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 179}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2015-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-02-24', 'studyFirstSubmitDate': '2017-03-21', 'resultsFirstSubmitDate': '2017-04-06', 'studyFirstSubmitQcDate': '2017-03-29', 'lastUpdatePostDateStruct': {'date': '2018-11-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-02-24', 'studyFirstPostDateStruct': {'date': '2017-04-04', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2018-11-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Pre-eclampsia in Both Arms', 'timeFrame': 'From 20 weeks of pregnancy till event of pre-eclampsia seen, whichever came first, assessed up to 32 weeks.', 'description': 'Occurrence of pre-eclampsia or not in all patients irrespective of Vitamin D dose.'}], 'secondaryOutcomes': [{'measure': 'Change in Vitamin D Level', 'timeFrame': 'At 36th week of pregnancy', 'description': 'Level of Improvement in Vitamin D status in both arms'}, {'measure': 'Number of Patients With Intrauterine Growth Retardation', 'timeFrame': 'At delivery', 'description': 'Patients having fetus with retardation of growth in both arms.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Maternal vitamin D', 'Deficiency', 'Insufficiency', 'Pregnancy', 'Pre-eclampsia', 'IUGR'], 'conditions': ['Vitamin D Deficiency', 'Pre-Eclampsia']}, 'descriptionModule': {'briefSummary': 'Vitamin D deficient pregnant ladies were selected and randomized into 2 groups for routine daily dose of multivitamin (400IU vitamin D3) versus maximum safest treatment daily dose (4000IU vitamin D3). Participants were assessed and compared for number of pre-eclampsia cases.', 'detailedDescription': 'Vitamin D3 has key role in decidualization and implantation of placenta.Vitamin D deficiency is thought to have positive association with pre-eclampsia.Vitamin D deficiency is highly prevalent in some parts of the world and it is not universally screened antenatally. Pre-eclampsia is a known multifactorial pregnancy disorder with significant maternal and perinatal morbidity and mortality. Vitamin D3 has a down-regulating effect on inflammatory pathways and reducing endothelial cell damage.\n\nInvestigators want to assess in vitamin D deficient group whether treatment reduces the risk of pre-eclampsia.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '20 Years', 'genderBased': True, 'genderDescription': 'Pregnant population', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Confirmed singleton pregnancy of less than 13 completed weeks of gestation at the time of consent.\n* Planned to receive antenatal care in King Fahad Medical City antenatal clinic.\n* The ability to provide written informed consent at the first visit.\n* Low risk pregnancy; and Serum vitamin D3 levels less than \\< 25nmol/L.\n\nExclusion Criteria:\n\n* Mothers with pregnancy with abnormal foetus.\n* Previous history of hypertension, pre-eclampsia, recurrent miscarriages.\n* Chronic kidney disease, chronic liver disease, and malignancy.'}, 'identificationModule': {'nctId': 'NCT03101150', 'briefTitle': 'Effect of Vitamin D3 Supplementation in Pregnancy on Risk of Pre-eclampsia', 'organization': {'class': 'OTHER_GOV', 'fullName': 'King Fahad Medical City'}, 'officialTitle': 'Effect of Antenatal Vitamin D3 Supplementation on Risk of Pre-eclampsia', 'orgStudyIdInfo': {'id': 'IRB00008644'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '400 IU Vitamin D3', 'description': '400IU vitamin D3 contained in antenatal multivitamin once daily by mouth starting from 14 weeks of pregnancy till delivery.', 'interventionNames': ['Drug: 400 IU Vitamin D3']}, {'type': 'EXPERIMENTAL', 'label': '4000 IU Vitamin D3', 'description': '4000 IU Vitamin D3 drops once daily by mouth starting from 14 weeks of pregnancy till delivery.', 'interventionNames': ['Drug: 4000 IU Vitamin D3']}], 'interventions': [{'name': '400 IU Vitamin D3', 'type': 'DRUG', 'otherNames': ['Materna'], 'description': 'Antenatal multivitamin', 'armGroupLabels': ['400 IU Vitamin D3']}, {'name': '4000 IU Vitamin D3', 'type': 'DRUG', 'otherNames': ['Vidrop'], 'description': '4000 IU Vitamin D3 (cholecalciferol) daily = 40 drops daily', 'armGroupLabels': ['4000 IU Vitamin D3']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'King Fahad Medical City', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Consultant Obstetric and Gynecology', 'investigatorFullName': 'Aisha Mansoor Ali', 'investigatorAffiliation': 'King Fahad Medical City'}}}}