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dc.contributor.authorRayman, Margaret P
dc.contributor.authorWinther, Kristian Hillert
dc.contributor.authorPastor-Barriuso, Roberto 
dc.contributor.authorCold, Frederick
dc.contributor.authorThvilum, Marianne
dc.contributor.authorStranges, Saverio
dc.contributor.authorGuallar, Eliseo 
dc.contributor.authorCold, Søren
dc.identifier.citationFree Radic Biol Med . 2018 Nov 1;127:46-54es_ES
dc.description.abstractSelenium, an essential trace element, is incorporated into selenoproteins with a wide range of health effects. Selenoproteins may reach repletion at a plasma selenium concentration of ~ 125 µg/L, at which point the concentration of selenoprotein P reaches a plateau; whether sustained concentrations higher than this are beneficial, or indeed detrimental, is unknown. In a population of relatively low selenium status, we aimed to determine the effect on mortality of long-term selenium supplementation at different dose levels. The Denmark PRECISE study was a single-centre, randomised, double-blinded, placebo-controlled, multi-arm, parallel clinical trial with four groups. Participants were 491 male and female volunteers aged 60-74 years, recruited at Odense University Hospital, Denmark. The trial was initially designed as a 6-month pilot study, but supplemental funding allowed for extension of the study and mortality assessment. Participants were randomly assigned to treatment with 100, 200, or 300 µg selenium/d as selenium-enriched-yeast or placebo-yeast for 5 years from randomization in 1998-1999 and were followed up for mortality for a further 10 years (through March 31, 2015). During 6871 person-years of follow-up, 158 deaths occurred. In an intention-to-treat analysis, the hazard ratio (95% confidence interval) for all-cause mortality comparing 300 µg selenium/d to placebo was 1.62 (0.66, 3.96) after 5 years of treatment and 1.59 (1.02, 2.46) over the entire follow-up period. The 100 and 200 µg/d doses showed non-significant decreases in mortality during the intervention period that disappeared after treatment cessation. Although we lacked power for endpoints other than all-cause mortality, the effects on cancer and cardiovascular mortality appeared similar. A 300 µg/d dose of selenium taken for 5 years in a country with moderately-low selenium status increased all-cause mortality 10 years later. While our study was not initially designed to evaluate mortality and the sample size was limited, our findings indicate that total selenium intake over 300 µg/d and high-dose selenium supplements should be avoided.es_ES
dc.description.sponsorshipThis work was supported by: the Danish Cancer Society; The Research Foundation of the County of Funen; Cypress Systems Inc.; The Danish Veterinary and Food Administration; The Council of Consultant Physicians, Odense University Hospital; The Clinical Experimental Research Foundation at Department of Oncology, Odense University Hospital; K.A Rohde's Foundation; Dagmar Marshall's Foundation. Pharma Nord ApS, Vejle, Denmark provided the selenium and placebo tablets. The funders had no role in the design or conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.es_ES
dc.relation.isversionofPublisher's versiones_ES
dc.subjectPlasma selenium concentrationes_ES
dc.subjectSelenium intakees_ES
dc.subjectSelenium dosees_ES
dc.subjectSelenium toxicityes_ES
dc.subjectCancer mortalityes_ES
dc.subjectCardiovascular mortalityes_ES
dc.subjectRandomised controlled triales_ES
dc.subjectDenmark PRECISEes_ES
dc.subject.meshMortality es_ES
dc.subject.meshAged es_ES
dc.subject.meshDenmark es_ES
dc.subject.meshDietary Supplements es_ES
dc.subject.meshDouble-Blind Method es_ES
dc.subject.meshFemale es_ES
dc.subject.meshHumans es_ES
dc.subject.meshMale es_ES
dc.subject.meshMiddle Aged es_ES
dc.subject.meshPilot Projects es_ES
dc.subject.meshSelenium es_ES
dc.subject.meshSurvival Analysis es_ES
dc.titleEffect of long-term selenium supplementation on mortality: Results from a multiple-dose, randomised controlled trial.es_ES
dc.rights.licenseAttribution-by/4.0 Internacional*
dc.identifier.journalFree radical biology & medicinees_ES
dc.repisalud.centroISCIII::Centro Nacional de Epidemologíaes_ES

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Attribution-by/4.0 Internacional
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