Ignite Creation Date:
2025-12-25 @ 3:20 AM
Ignite Modification Date:
2025-12-26 @ 1:59 AM
Study NCT ID:
NCT01232205
Status:
COMPLETED
Last Update Posted:
2010-12-02
First Post:
2010-11-01
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Antioxidant Supplementation in Pregnant Women
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011225', 'term': 'Pre-Eclampsia'}], 'ancestors': [{'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': 'D000975', 'term': 'Antioxidants'}], 'ancestors': [{'id': 'D001685', 'term': 'Biological Factors'}, {'id': 'D045504', 'term': 'Molecular Mechanisms of Pharmacological Action'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D020011', 'term': 'Protective Agents'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D020313', 'term': 'Specialty Uses of Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'yudi@med.showa-u.ac.jp', 'phone': '+44 753 870 6897', 'title': 'Yuditiya Purwosunu', 'organization': 'Dept Obstetrics Gynecology Indonesia University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'nine months', 'description': 'monthly questionare', 'eventGroups': [{'id': 'EG000', 'title': 'Micronutrient Antioxidant', 'description': 'Supplementation with milk enriched with vitamin and mineral, such as Cu, Zn, Mn, Fe, carotene, vitamin B6, B12, C, E, selenium, and calcium', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Preeclampsia', 'timeFrame': '40 weeks', 'description': 'Preeclampsia was defined as gestational hypertension (systolic pressure ≥140 mmHg or diastolic blood pressure ≥ 90 mmHg \\[Korotkoff V\\] on ≥ 2 occasions after 20 weeks gestation) with proteinuria (\\> 0.3 g/day). Severe preeclampsia was defined by the presence of \\>1 of the following: (a) severe gestational hypertension (systolic pressure ≥160 mmHg or diastolic blood pressure ≥110 mmHg on 2 occasions after gestational week 20), or (b) severe proteinuria (≥5g protein in a 24-h urine specimen or ≥3 g in 2 random urine samples collected ≥4 h apart)', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Cell-free mRNA', 'timeFrame': '40 weeks', 'description': 'Secondary outcome were level of mRNA level of angiogenic factors (vascular endothelial growth factor receptor-1 (VEGFR-1), placental growth factor (PlGF) and endoglin(ENG)); antioxidant status (FRAP, heme oksigenase-1 (HO-1) and superoxide-dismutase (SOD))', 'reportingStatus': 'NOT_POSTED'}, {'type': 'PRIMARY', 'title': 'Preeclampsia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Micronutrient Antioxidant', 'description': 'Supplementation with milk enriched with vitamin and mineral, such as Cu, Zn, Mn, Fe, carotene, vitamin B6, B12, C, E, selenium, and calcium'}, {'id': 'OG001', 'title': 'Control'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '9 months', 'description': 'Preeclampsia was defined as gestational hypertension (systolic pressure ≥140 mmHg or diastolic blood pressure ≥ 90 mmHg \\[Korotkoff V\\] on ≥ 2 occasions after 20 weeks gestation) with proteinuria (\\> 0.3 g/day). Severe preeclampsia was defined by the presence of \\>1 of the following: (a) severe gestational hypertension (systolic pressure ≥160 mmHg or diastolic blood pressure ≥110 mmHg on 2 occasions after gestational week 20), or (b) severe proteinuria (≥5g protein in a 24-h urine specimen or ≥3 g in 2 random urine samples collected ≥4 h apart)', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Micronutrient Antioxidant', 'description': 'Supplementation with milk enriched with vitamin and mineral, such as Cu, Zn, Mn, Fe, carotene, vitamin B6, B12, C, E, selenium, and calcium'}, {'id': 'FG001', 'title': 'Control'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '52'}, {'groupId': 'FG001', 'numSubjects': '58'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '49'}, {'groupId': 'FG001', 'numSubjects': '55'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}], 'recruitmentDetails': 'Recruitment started in June 2001 and completed in December 2009, Department of Obstetrics and Gynaecology, University of Indonesia, at Cipto Mangunkusumo National Hospital', 'preAssignmentDetails': 'There were 110 (65.4 percent) eligible subjects from 168 pregnant women, because of ferric reducing ability of plasma (FRAP) level measured'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'BG000'}, {'value': '58', 'groupId': 'BG001'}, {'value': '110', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Micronutrient Antioxidant', 'description': 'Supplementation with milk enriched with vitamin and mineral, such as Cu, Zn, Mn, Fe, carotene, vitamin B6, B12, C, E, selenium, and calcium'}, {'id': 'BG001', 'title': 'Control'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '52', 'groupId': 'BG000'}, {'value': '58', 'groupId': 'BG001'}, {'value': '110', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '28.1', 'spread': '5.08', 'groupId': 'BG000'}, {'value': '29.7', 'spread': '5.07', 'groupId': 'BG001'}, {'value': '28.9', 'spread': '5.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '52', 'groupId': 'BG000'}, {'value': '58', 'groupId': 'BG001'}, {'value': '110', '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': 'Indonesia', 'categories': [{'measurements': [{'value': '52', 'groupId': 'BG000'}, {'value': '58', 'groupId': 'BG001'}, {'value': '110', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 168}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-12', 'completionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-11-02', 'studyFirstSubmitDate': '2010-11-01', 'resultsFirstSubmitDate': '2010-11-02', 'studyFirstSubmitQcDate': '2010-11-01', 'lastUpdatePostDateStruct': {'date': '2010-12-02', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2010-11-02', 'studyFirstPostDateStruct': {'date': '2010-11-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-12-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Preeclampsia', 'timeFrame': '40 weeks', 'description': 'Preeclampsia was defined as gestational hypertension (systolic pressure ≥140 mmHg or diastolic blood pressure ≥ 90 mmHg \\[Korotkoff V\\] on ≥ 2 occasions after 20 weeks gestation) with proteinuria (\\> 0.3 g/day). Severe preeclampsia was defined by the presence of \\>1 of the following: (a) severe gestational hypertension (systolic pressure ≥160 mmHg or diastolic blood pressure ≥110 mmHg on 2 occasions after gestational week 20), or (b) severe proteinuria (≥5g protein in a 24-h urine specimen or ≥3 g in 2 random urine samples collected ≥4 h apart)'}, {'measure': 'Preeclampsia', 'timeFrame': '9 months', 'description': 'Preeclampsia was defined as gestational hypertension (systolic pressure ≥140 mmHg or diastolic blood pressure ≥ 90 mmHg \\[Korotkoff V\\] on ≥ 2 occasions after 20 weeks gestation) with proteinuria (\\> 0.3 g/day). Severe preeclampsia was defined by the presence of \\>1 of the following: (a) severe gestational hypertension (systolic pressure ≥160 mmHg or diastolic blood pressure ≥110 mmHg on 2 occasions after gestational week 20), or (b) severe proteinuria (≥5g protein in a 24-h urine specimen or ≥3 g in 2 random urine samples collected ≥4 h apart)'}], 'secondaryOutcomes': [{'measure': 'Cell-free mRNA', 'timeFrame': '40 weeks', 'description': 'Secondary outcome were level of mRNA level of angiogenic factors (vascular endothelial growth factor receptor-1 (VEGFR-1), placental growth factor (PlGF) and endoglin(ENG)); antioxidant status (FRAP, heme oksigenase-1 (HO-1) and superoxide-dismutase (SOD))'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['antioxidant supplementation', 'preeclampsia'], 'conditions': ['Pregnant Women', 'Preeclampsia']}, 'referencesModule': {'references': [{'pmid': '22563751', 'type': 'DERIVED', 'citation': 'Wibowo N, Purwosunu Y, Sekizawa A, Farina A, Idriansyah L, Fitriana I. Antioxidant supplementation in pregnant women with low antioxidant status. J Obstet Gynaecol Res. 2012 Sep;38(9):1152-61. doi: 10.1111/j.1447-0756.2012.01855.x. Epub 2012 May 8.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the benefit of several micro nutrients of antioxidants (using milk) in a cohort of women with low antioxidant status and the changes in cell-free mRNA.', 'detailedDescription': 'Preeclampsia remains one of leading causes of maternal and perinatal mortality and morbidity. Despite intensive research, the cause of preeclampsia has not been established. One of the theories is exaggeration of systemic inflammatory that might induce reactive oxygen species (ROS). It has been proposed that pregnancy will progress uneventfully if adequate antioxidant exists to buffer ROS. The ROS can induce endothelial dysfunction which leads to clinical symptoms of hypertension and proteinuria in preeclampsia. Several large randomized clinical trials of antioxidant supplementation have concluded that there were no benefits of antioxidants supplementation for prevention of preeclampsia. However, there is limited information about benefits of antioxidants in women with low antioxidant status at early gestation that deprived of the antioxidant most. Our aim, therefore, in this study was to assess whether early supplementation with milk enriched with vitamin and mineral, such as Cu, Zn, Mn, Fe, carotene, vitamin B6, B12, C, E, selenium, and calcium lowers the risk of preeclampsia in women with low antioxidant status at early gestation.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* pregnant women with 8-12 weeks of gestation\n\nExclusion Criteria:\n\n* known multiple pregnancy\n* known fetal anomaly\n* known thrombophilia\n* known infections and mola hydatidosa\n* chronic renal failure\n* uncontrolled hypertension\n* known placental abnormalities\n* documented uterine bleeding within a week of screening\n* uterine malformation\n* history of medical and metabolic complication such as heart disease or diabetes'}, 'identificationModule': {'nctId': 'NCT01232205', 'acronym': 'ASIP1', 'briefTitle': 'Antioxidant Supplementation in Pregnant Women', 'organization': {'class': 'OTHER', 'fullName': 'Showa University'}, 'officialTitle': 'Antioxidant Supplementation in Pregnant Women With Low Antioxidant Status', 'orgStudyIdInfo': {'id': 'asip02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'micronutrient antioxidant', 'description': 'Supplementation with milk enriched with vitamin and mineral, such as Cu, Zn, Mn, Fe, carotene, vitamin B6, B12, C, E, selenium, and calcium', 'interventionNames': ['Dietary Supplement: micronutrient antioxidant']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'interventionNames': ['Dietary Supplement: Control']}], 'interventions': [{'name': 'micronutrient antioxidant', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['antioxidant'], 'description': 'Supplementation with milk enriched with vitamin and mineral, such as Cu, Zn, Mn, Fe, carotene, vitamin B6, B12, C, E, selenium, and calcium', 'armGroupLabels': ['micronutrient antioxidant']}, {'name': 'Control', 'type': 'DIETARY_SUPPLEMENT', 'description': 'supplementation with milk', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13210', 'city': 'Jakarta', 'state': 'Jakarta Special Capital Region', 'country': 'Indonesia', 'facility': 'Cipto Mangunkusumo National Hospital', 'geoPoint': {'lat': -6.21462, 'lon': 106.84513}}], 'overallOfficials': [{'name': 'Noroyono Wibowo, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Dept Obstetrics Gynecology, Indonesia University'}, {'name': 'Yuditiya Purwosunu, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dept Obstetrics Gynecology Indonesia University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Showa University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Indonesia University', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Yuditiya Purwosunu', 'oldOrganization': 'Dept Obstetrics Gynecology, Indonesia University'}}}}