Ignite Creation Date:
2025-12-26 @ 10:44 PM
Ignite Modification Date:
2025-12-26 @ 10:44 PM
Study NCT ID:
NCT00005412
Status:
COMPLETED
Last Update Posted:
2016-05-13
First Post:
2000-05-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Dietary Antioxidants and Atherosclerosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050197', 'term': 'Atherosclerosis'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D016893', 'term': 'Carotid Stenosis'}], 'ancestors': [{'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002340', 'term': 'Carotid Artery Diseases'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL'}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1992-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2000-06', 'completionDateStruct': {'date': '1995-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-05-12', 'studyFirstSubmitDate': '2000-05-25', 'studyFirstSubmitQcDate': '2000-05-25', 'lastUpdatePostDateStruct': {'date': '2016-05-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2000-05-26', 'type': 'ESTIMATED'}}, 'conditionsModule': {'conditions': ['Atherosclerosis', 'Cardiovascular Diseases', 'Heart Diseases', 'Carotid Stenosis']}, 'referencesModule': {'references': [{'pmid': '7554194', 'type': 'BACKGROUND', 'citation': 'Kritchevsky SB, Shimakawa T, Tell GS, Dennis B, Carpenter M, Eckfeldt JH, Peacher-Ryan H, Heiss G. Dietary antioxidants and carotid artery wall thickness. The ARIC Study. Atherosclerosis Risk in Communities Study. Circulation. 1995 Oct 15;92(8):2142-50. doi: 10.1161/01.cir.92.8.2142.'}, {'pmid': '9734754', 'type': 'BACKGROUND', 'citation': 'Kritchevsky SB, Tell GS, Shimakawa T, Dennis B, Li R, Kohlmeier L, Steere E, Heiss G. Provitamin A carotenoid intake and carotid artery plaques: the Atherosclerosis Risk in Communities Study. Am J Clin Nutr. 1998 Sep;68(3):726-33. doi: 10.1093/ajcn/68.3.726.'}]}, 'descriptionModule': {'briefSummary': 'To examine the role of dietary antioxidants in the etiology of atherosclerosis in both sexes and in whites and Blacks.', 'detailedDescription': 'BACKGROUND:\n\nAtherosclerosis is this nation\'s leading cause of death for males and females, and Blacks and whites. There is mounting evidence that the oxidation of blood low density lipoproteins (LDL) plays an important role in the pathogenesis of this disease. LDL oxidation can be prevented by several dietary antioxidants, in particular, vitamin C, vitamin E, and beta-carotene. There is preliminary evidence that dietary antioxidants may slow the natural history of atherosclerosis in humans. Until now studies in this area have included predominantly white males with symptomatic disease.\n\nDESIGN NARRATIVE:\n\nThe case-control study used data collected in ARIC to test the hypothesis that individuals in the lowest quintile of vitamin C, vitamin E and carotenoid consumption were at higher risk of asymptomatic atherosclerosis than those consuming greater amounts. Antioxidant intake was assessed by a validated food frequency questionnaire and a diet supplement survey. Cases were those with asymptomatic carotid artery atherosclerosis as determined by B-mode ultrasonography. Controls were those without evidence of carotid artery atherosclerosis. Secondary analyses determined which sex-race subgroups were at particular risk due to low antioxidant consumption.\n\nThe study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'No eligibility criteria'}, 'identificationModule': {'nctId': 'NCT00005412', 'briefTitle': 'Dietary Antioxidants and Atherosclerosis', 'organization': {'class': 'NIH', 'fullName': 'National Heart, Lung, and Blood Institute (NHLBI)'}, 'orgStudyIdInfo': {'id': '4330'}, 'secondaryIdInfos': [{'id': 'R03HL047408', 'link': 'https://reporter.nih.gov/quickSearch/R03HL047408', 'type': 'NIH'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}}}}