Age Related Eye Disease Study 2 - Follow-on Study
Age Related Eye Disease Study 2 - Follow-on Study
批准号:
9568702
负责人:
TRACI E CLEMONS
金额:
$35.66万
依托单位:
依托单位国家:
美国
项目类别:
财政年份:
2013
资助国家:
美国
项目状态:
已结题
起止时间:
2013-09-26 至 2018-09-25
关键词:
Ancillary StudyArchivesAscorbic AcidAuthorization documentationBackBeta CaroteneBiometryCalendarCataractCataract ExtractionCertificationCessation of lifeCollaborationsCommunicationConsent FormsConsultationsContractorContractsDataData AnalysesData CollectionData SetDatabasesDevelopmentDiagnosisDiagnosticDiseaseDocumentationDoseElectronic MailEnrollmentEnsureEventEye diseasesFollow-Up StudiesFormulationHealthHealth Insurance Portability and Accountability ActIndividualInformation TechnologyInformed ConsentLife StyleLinkLuteinMalignant NeoplasmsMalignant neoplasm of lungManualsMedicalMedical RecordsMethodsModificationMonitorNutritional StudyOralOutcomePaperParticipantPathologyPerformancePhysiciansPoliciesPress ReleasesProceduresProcessProtocols documentationPublicationsRandomized Controlled Clinical TrialsRecording of previous eventsReportingResourcesRetinalRiskSafetyScheduleSecureSecurityServicesSiteSlideSourceStandardizationSurveysSystemTelephone InterviewsTestingTrainingTranslational ResearchUpdateValidationVisitVitaminsWritingZincage relatedagedbaseclinical research sitecohortdata managementelectronic dataexperiencefollow-upindexinglensmeetingsmortalityrandomized trialweb sitezeaxanthin
中文摘要
AREDS2是叶黄素/玉米黄质随机对照临床试验中时间最长、规模最大的试验之一。AREDS2队列为评估使用这些化合物的安全性和有效性数据提供了宝贵的资源。中心焦点将集中在眼(视网膜和晶状体为基础)和癌症为基础的终点。2009年,Satia等人报道了50 - 76岁的维生素与生活方式(VITAL)研究参与者长期服用叶黄素会增加患肺癌的风险。由于AREDS2是一项随机对照临床试验,对研究参与者的进一步随访将使我们能够确定大剂量口服叶黄素补充剂是否会增加肺癌的风险。有关死亡率的信息将通过电话访谈和国家死亡指数搜索收集。我们还将利用这个机会,通过电话采访询问白内障手术和黄斑变性治疗的眼科结果。死亡率与眼部疾病有关,特别是晚期黄斑变性和白内障,正如我们之前对黄斑变性和白内障的AREDS配方(维生素C、E、β -胡萝卜素和锌)的随机试验所证明的那样。
英文摘要
AREDS2 is one of the longest and perhaps the largest randomized controlled clinical trial of lutein/zeaxanthin. The AREDS2 cohort provides valuable resources with which to assess safety and efficacy data on use of these compounds. A central focus will be on ocular- (retinal- and lens-based) and cancer-based endpoints. In 2009, Satia et al. reported an increased risk of lung cancer associated with long term lutein supplement use participants of the VITamins And Lifestyle (VITAL) Study aged 50 to 76 years.a As AREDS2 is a randomized controlled clinical trial, additional follow-up of study participants would permit us to determinate whether high-dose oral lutein supplement use increases risk of lung cancer. Information regarding mortality will be collected through telephone interviews and the National Death Index search. We will also use this opportunity to ask for the ocular outcomes by asking at the telephone interview for cataract surgery and treatment for AMD. Mortality is associated with ocular disease, specifically advanced AMD and cataract, as demonstrated by our previous randomized trial of the AREDS formulation (Vitamins C, E, beta-carotene, and zinc) for AMD and cataract.
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财政年份:2014
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依托单位:
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财政年份:2012
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海外基金