Ignite Creation Date:
2025-12-24 @ 10:31 PM
Ignite Modification Date:
2025-12-25 @ 8:04 PM
Study NCT ID:
NCT00583635
Status:
COMPLETED
Last Update Posted:
2012-10-05
First Post:
2007-12-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Early Pregnancy Antioxidant Supplementation in the Prevention of Preeclampsia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Blood to be analyzed for various markers, then discarded, none to be retained.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 684}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-10', 'completionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-10-03', 'studyFirstSubmitDate': '2007-12-20', 'studyFirstSubmitQcDate': '2007-12-28', 'lastUpdatePostDateStruct': {'date': '2012-10-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-12-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Development of preeclampsia during pregnancy', 'timeFrame': 'Preeclampsia at any time during gestation'}], 'secondaryOutcomes': [{'measure': 'The observed incidence of preterm labor, premature rupture of membranes, perinatal loss', 'timeFrame': 'First, second and third trimester'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Preeclampsia', 'Prevention', 'Food Supplement'], 'conditions': ['Preeclampsia', 'Pregnancy Loss']}, 'descriptionModule': {'briefSummary': 'Use of Juice Plus+ food supplements, when initiated in the first trimester and used continuously thereafter, will result in a lower incidence of preeclampsia and pregnancy complications. This is a prospective randomized and blinded placebo controlled study sponsored by NSA, LLC of Memphis, TN.', 'detailedDescription': 'Not desired'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '44 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients cared for in the University of Mississippi Medical Center', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pregnant Patients seen in first trimester with low or high risk pregnancy\n\nExclusion Criteria:\n\n* Pregnant patients first seen after the first trimester\n* Unlikely to continue care in our system\n* Unwilling to comply with rigor of taking food supplements throughout gestation'}, 'identificationModule': {'nctId': 'NCT00583635', 'briefTitle': 'Early Pregnancy Antioxidant Supplementation in the Prevention of Preeclampsia', 'organization': {'class': 'OTHER', 'fullName': 'University of Mississippi Medical Center'}, 'officialTitle': 'Minimizing Early Pregnancy Oxidative Stress to Maximize Healthy Pregnancy Outcome: Reducing Preeclampsia and Reproductive Loss With Antioxidant-Rich Tablet Supplementation Initiated in the First Trimester', 'orgStudyIdInfo': {'id': 'IRB File # 2003-0119'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1', 'description': 'Low Risk Pregnancy, Placebo'}, {'label': '2', 'description': 'Low Risk Pregnancy, Active Food Supplement'}, {'label': '3', 'description': 'High Risk Pregnancy, Placebo'}, {'label': '4', 'description': 'High Risk Pregnancy, Active Food Supplement'}]}, 'contactsLocationsModule': {'locations': [{'zip': '39216', 'city': 'Jackson', 'state': 'Mississippi', 'country': 'United States', 'facility': 'University of Mississippi Medical Center', 'geoPoint': {'lat': 32.29876, 'lon': -90.18481}}], 'overallOfficials': [{'name': 'James N Martin, Jr., MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Mississippi Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Mississippi Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'James Martin', 'investigatorAffiliation': 'University of Mississippi Medical Center'}}}}