Ignite Creation Date:
2025-12-24 @ 11:53 PM
Ignite Modification Date:
2025-12-25 @ 9:48 PM
Study NCT ID:
NCT04633551
Status:
COMPLETED
Last Update Posted:
2023-09-21
First Post:
2020-11-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Vascular Inflammation and Anti-inflammatory Supplements After Adverse Pregnancy Outcomes
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011225', 'term': 'Pre-Eclampsia'}, {'id': 'D047928', 'term': 'Premature Birth'}, {'id': 'D005317', 'term': 'Fetal Growth Retardation'}, {'id': 'D046110', 'term': 'Hypertension, Pregnancy-Induced'}, {'id': 'D007249', 'term': 'Inflammation'}], 'ancestors': [{'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007752', 'term': 'Obstetric Labor, Premature'}, {'id': 'D007744', 'term': 'Obstetric Labor Complications'}, {'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': 'D006973', 'term': 'Hypertension'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'lanecord@mailbox.sc.edu', 'phone': '8037777568', 'title': 'Abbi Lane-Cordova', 'organization': 'University of South Carolina'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'We began the study during the peak of the covid pandemic, and research capacity was limited. Recruitment was low. Target numbers were not reached.'}}, 'adverseEventsModule': {'timeFrame': '1 month', 'eventGroups': [{'id': 'EG000', 'title': 'Intervention', 'description': 'Participants in this arm will receive a commercially available anti-inflammatory supplement.\n\nAnti-inflammatory supplement: commercially available combination of curcumin, quercitin, resveratrol, and green tea', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 0, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control', 'description': 'Participants in this arm will not receive a commercially available anti-inflammatory supplement.', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 0, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Blood Pressure (mmHg)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Participants in this arm will receive a commercially available anti-inflammatory supplement.\n\nAnti-inflammatory supplement: commercially available combination of curcumin, quercitin, resveratrol, and green tea'}, {'id': 'OG001', 'title': 'Control', 'description': 'Participants in this arm will not receive a commercially available anti-inflammatory supplement.'}], 'classes': [{'categories': [{'measurements': [{'value': '122', 'spread': '9', 'groupId': 'OG000'}, {'value': '116', 'spread': '9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 month', 'description': 'Investigators will measure blood pressure in the arm and use applanation tonometry to estimate aortic blood pressure', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed Visit 2.'}, {'type': 'PRIMARY', 'title': 'Arterial Stiffness (m/s)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Participants in this arm will receive a commercially available anti-inflammatory supplement.\n\nAnti-inflammatory supplement: commercially available combination of curcumin, quercitin, resveratrol, and green tea'}, {'id': 'OG001', 'title': 'Control', 'description': 'Participants in this arm will not receive a commercially available anti-inflammatory supplement.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.2', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '7.8', 'spread': '1.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 month', 'description': 'Arterial stiffness will be measured with pulse wave velocity using applanation tonometry and heart rate', 'unitOfMeasure': 'm/s', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Only participants who completed Visit 2.'}, {'type': 'PRIMARY', 'title': 'Augmentation Index (%)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Participants in this arm will receive a commercially available anti-inflammatory supplement.\n\nAnti-inflammatory supplement: commercially available combination of curcumin, quercitin, resveratrol, and green tea'}, {'id': 'OG001', 'title': 'Control', 'description': 'Participants in this arm will not receive a commercially available anti-inflammatory supplement.'}], 'classes': [{'categories': [{'measurements': [{'value': '23', 'spread': '3', 'groupId': 'OG000'}, {'value': '22', 'spread': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 month', 'description': 'Applanation tonometry will be used to describe systolic blood pressure augmentation, a measure of arterial wave reflection intensity.', 'unitOfMeasure': 'percentage', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Endothelial Function (Reactive Hyperemia)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Participants in this arm will receive a commercially available anti-inflammatory supplement.\n\nAnti-inflammatory supplement: commercially available combination of curcumin, quercitin, resveratrol, and green tea'}, {'id': 'OG001', 'title': 'Control', 'description': 'Participants in this arm will not receive a commercially available anti-inflammatory supplement.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.6', 'spread': '3.4', 'groupId': 'OG000'}, {'value': '7.6', 'spread': '5.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 month', 'description': 'Venous occlusion plethysmography will be used to mease the change in forearm blood flow after a 5-min occlusion', 'unitOfMeasure': 'ml/100 mg tissue/min', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Inflammatory Vascular Biomarkers (pg/dL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Participants in this arm will receive a commercially available anti-inflammatory supplement.\n\nAnti-inflammatory supplement: commercially available combination of curcumin, quercitin, resveratrol, and green tea'}, {'id': 'OG001', 'title': 'Control', 'description': 'Participants in this arm will not receive a commercially available anti-inflammatory supplement.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Undetected values', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Undetected values', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 month', 'description': 'concentrations of circulating adhesion molecules ICAM and VCAM', 'unitOfMeasure': 'pg/dl', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Unable to perform blood draws on all participants.'}, {'type': 'SECONDARY', 'title': 'Acceptability of Intervention (Likert Scales From 1-5; Not Likely at All to Extremely Likely and Free Text Fields)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Participants in this arm will receive a commercially available anti-inflammatory supplement.\n\nAnti-inflammatory supplement: commercially available combination of curcumin, quercitin, resveratrol, and green tea'}, {'id': 'OG001', 'title': 'Control', 'description': 'Participants in this arm will not receive a commercially available anti-inflammatory supplement.'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1 month', 'description': 'Surveys regarding opinion and likelihood of taking supplements. Here we report the number of participants who thought supplements were somewhat or extremely useful (Likert score of 4-5) for improving health.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Perception of Intervention (15-20 Minute Interview)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Participants in this arm will receive a commercially available anti-inflammatory supplement.\n\nAnti-inflammatory supplement: commercially available combination of curcumin, quercitin, resveratrol, and green tea'}, {'id': 'OG001', 'title': 'Control', 'description': 'Participants in this arm will not receive a commercially available anti-inflammatory supplement.'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1 month', 'description': 'Interviews will be used to determine barriers and facilitators of adherence. We report number of participants who were happy with contact with study team for adherence reminders.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Only Intervention group participants who completed Visit 2 were included.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Intervention', 'description': 'Participants in this arm will receive a commercially available anti-inflammatory supplement.\n\nAnti-inflammatory supplement: commercially available combination of curcumin, quercitin, resveratrol, and green tea'}, {'id': 'FG001', 'title': 'Control', 'description': 'Participants in this arm will not receive a commercially available anti-inflammatory supplement.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Intervention', 'description': 'Participants in this arm will receive a commercially available anti-inflammatory supplement.\n\nAnti-inflammatory supplement: commercially available combination of curcumin, quercitin, resveratrol, and green tea'}, {'id': 'BG001', 'title': 'Control', 'description': 'Participants in this arm will not receive a commercially available anti-inflammatory supplement.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}], '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': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '8', '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': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '33', 'spread': '6', 'groupId': 'BG000'}, {'value': '30', 'spread': '6', 'groupId': 'BG001'}, {'value': '32', 'spread': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', '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': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Systolic Blood Pressure', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '118', 'spread': '22', 'groupId': 'BG000'}, {'value': '119', 'spread': '15', 'groupId': 'BG001'}, {'value': '118', 'spread': '18', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmHg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Arterial stiffness', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '6.4', 'spread': '0.5', 'groupId': 'BG000'}, {'value': '8.3', 'spread': '2.7', 'groupId': 'BG001'}, {'value': '7.3', 'spread': '1.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'm/s', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Augmentation index', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '24', 'spread': '6', 'groupId': 'BG000'}, {'value': '25', 'spread': '5', 'groupId': 'BG001'}, {'value': '24', 'spread': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': "Augmentation index is a measure of arterial wave reflection intensity. It is related to the heart's workload.", 'unitOfMeasure': 'percentage', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Central systolic blood pressure', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '108', 'spread': '15', 'groupId': 'BG000'}, {'value': '110', 'spread': '13', 'groupId': 'BG001'}, {'value': '109', 'spread': '14', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmHg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Reactive hyperemia', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '7.7', 'spread': '3.3', 'groupId': 'BG000'}, {'value': '13.2', 'spread': '12.5', 'groupId': 'BG001'}, {'value': '9.7', 'spread': '7.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'ml/100 mg tissue/min', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Inflammatory biomarker IL-6', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Mean values for the biomarker were below detection.', 'groupId': 'BG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Mean values for the biomarker were below detection.', 'groupId': 'BG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Mean values for the biomarker were below detection.', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'pg/dl', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'We did not perform blood draws successfully on all participants.'}], 'populationDescription': 'There were 6 participants enrolled in the Intervention. One participant was lost to follow up and did not complete Visit 2. we analyzed data for those who completed Visit 2.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-11-13', 'size': 159742, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-10-04T09:55', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 9}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2022-05-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-19', 'studyFirstSubmitDate': '2020-11-06', 'resultsFirstSubmitDate': '2022-10-04', 'studyFirstSubmitQcDate': '2020-11-12', 'lastUpdatePostDateStruct': {'date': '2023-09-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-09-19', 'studyFirstPostDateStruct': {'date': '2020-11-18', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-09-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Blood Pressure (mmHg)', 'timeFrame': '1 month', 'description': 'Investigators will measure blood pressure in the arm and use applanation tonometry to estimate aortic blood pressure'}, {'measure': 'Arterial Stiffness (m/s)', 'timeFrame': '1 month', 'description': 'Arterial stiffness will be measured with pulse wave velocity using applanation tonometry and heart rate'}, {'measure': 'Augmentation Index (%)', 'timeFrame': '1 month', 'description': 'Applanation tonometry will be used to describe systolic blood pressure augmentation, a measure of arterial wave reflection intensity.'}, {'measure': 'Endothelial Function (Reactive Hyperemia)', 'timeFrame': '1 month', 'description': 'Venous occlusion plethysmography will be used to mease the change in forearm blood flow after a 5-min occlusion'}], 'secondaryOutcomes': [{'measure': 'Inflammatory Vascular Biomarkers (pg/dL)', 'timeFrame': '1 month', 'description': 'concentrations of circulating adhesion molecules ICAM and VCAM'}, {'measure': 'Acceptability of Intervention (Likert Scales From 1-5; Not Likely at All to Extremely Likely and Free Text Fields)', 'timeFrame': '1 month', 'description': 'Surveys regarding opinion and likelihood of taking supplements. Here we report the number of participants who thought supplements were somewhat or extremely useful (Likert score of 4-5) for improving health.'}, {'measure': 'Perception of Intervention (15-20 Minute Interview)', 'timeFrame': '1 month', 'description': 'Interviews will be used to determine barriers and facilitators of adherence. We report number of participants who were happy with contact with study team for adherence reminders.'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['adverse pregnancy outcome', 'inflammation', 'vascular health'], 'conditions': ['Pre-Eclampsia', 'Pre-Term', 'Intrauterine Growth Restriction', 'Hypertension in Pregnancy']}, 'descriptionModule': {'briefSummary': "Women who had an adverse pregnancy outcome (APO), such as preeclampsia, preterm birth, or gestational diabetes, have a higher risk for heart disease. Some of the extra risk for heart disease after APOs is thought to be caused by inflammation. Investigators will randomize women who had an APO in the past 3 years to receive an anti-inflammatory supplement or serve as a time control. Investigators will compare blood pressure, arterial stiffness, blood vessel reactivity, and blood markers of inflammation between women who did and did not receive the supplement. Investigators will determine women's attitudes about taking a dietary supplement and measure whether the participants who receive the supplement take all or most of the doses.", 'detailedDescription': "Research Design. Investigators will invite 56 women with an APO within the past 3 yrs to participate. Women will be randomly assigned to the 4-wk intervention group (n=28) or a standard care group (n=28) using a computerized random number generator, stratified by race. Assuming up to 25% with poor adherence, Investigators expect that 42 women (21 each arm) will complete the study. No data exist related to effects of supplementation on vascular function in our population, we assumed a medium effect size, i.e. Cohen's d\\~0.50 and accepting a β=0.80, to generate sample sizes. Generation of effect sizes is a key outcome of this study. Investigators will conduct a vascular assessment and blood draw at two visits: before the intervention begins and within 3 days of completing the intervention. Investigators will conduct visits during the early follicular phase of menstrual cycle to account for fluctuating hormones. Vascular testing will be performed in the supine position and ≥4 hours after a light meal. Surveys for Aim 2 will be completed within the first 2 weeks of study enrollment, and interviews for Aim 2 will be conducted at the end of Visit 2.\n\nAnti-inflammatory supplementation intervention. Participants randomized to the supplementation intervention will receive a commercially available supplement (100 mg curcumin phytosome, 100 mg quercetin phytosome, 100 mg green tea phytosome, 100 mg trans-resveratrol, 100 mg trans-pterostilbene). Participants will be asked to take 2 doses/day (1g total). Participants randomized to supplementation will receive a daily email reminding them to take the supplement. Covariates. Medical history, age, and sociodemographics will be obtained via self-report. Investigators will use validated surveys to determine physical activity, sedentary behavior, and smoking history. Height and weight will be measured.\n\nAcceptability of Dietary Supplementation. Investigators will administer surveys to all participants to understand their perceptions of dietary supplementation, including potential benefits and consequences associated with supplementation. Investigators will determine willingness to use supplements, barriers to supplementation, and who, i.e., physician or partner, influences their decision to use dietary supplements.\n\nAdherence and Barriers to Adherence. Investigators will count pills to determine adherence to supplementation regime. Investigators will assess each intervention participant's perceptions of supplementation with a brief interview at the final visit. Interviews will capture participant's perceptions of the role of supplementation for CVD prevention, and any side effects of supplementation. Investigators will ask participants to recommend ways to encourage participation and ask questions regarding their perceptions of the incentive structure and contact with the study team. Investigators will contact participants who drop out of the study to identify reasons for drop out."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Had a singleton pregnancy in the past 3 years that lasted 20 weeks or more\n* Most recent pregnancy was complicated by an APO\n\nExclusion Criteria:\n\n* currently pregnant or breastfeeding,\n* current smoking,\n* active cancer,\n* regular use of NSAIDs, steroidal medications, statins, or other anti-inflammatory supplements,\n* HIV/AIDS,\n* uncontrolled high blood pressure ( \\>160/\\>110 mmHg),\n* unwilling or unable to use a dietary supplement,\n* known sensitivity to resveratrol, curcumin, green tea, or quercetin'}, 'identificationModule': {'nctId': 'NCT04633551', 'acronym': 'VIA', 'briefTitle': 'Vascular Inflammation and Anti-inflammatory Supplements After Adverse Pregnancy Outcomes', 'organization': {'class': 'OTHER', 'fullName': 'University of South Carolina'}, 'officialTitle': 'Supplements to Improve Vascular Inflammation After an Adverse Pregnancy Outcome', 'orgStudyIdInfo': {'id': '10010335'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Participants in this arm will receive a commercially available anti-inflammatory supplement.', 'interventionNames': ['Dietary Supplement: Anti-inflammatory supplement']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Participants in this arm will not receive a commercially available anti-inflammatory supplement.'}], 'interventions': [{'name': 'Anti-inflammatory supplement', 'type': 'DIETARY_SUPPLEMENT', 'description': 'commercially available combination of curcumin, quercitin, resveratrol, and green tea', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '29208', 'city': 'Columbia', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Public Health Research Center', 'geoPoint': {'lat': 34.00071, 'lon': -81.03481}}], 'overallOfficials': [{'name': 'Abbi Lane-Cordova, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of South Carolina'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR'], 'timeFrame': 'Upon completion of the study', 'ipdSharing': 'YES', 'description': 'We will disseminate results at conferences and in medical journals. We are open to sharing limited datasets upon request.', 'accessCriteria': 'Contact the PI:\n\nAbbi Lane-Cordova lanecord@mailbox.sc.edu 803-777-7568'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of South Carolina', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Abbi Danielle Lane-Cordova', 'investigatorAffiliation': 'University of South Carolina'}}}}