B Vitamin andor n-3 Fatty Acid Supplementation and Health-Related Quality of Life Ancillary Findings from the SU.FOL.OM3 Randomized Trial.docVIP

BVitaminand/orn-3FattyAcidSupplementationand Health-RelatedQualityofLife:AncillaryFindingsfrom theSU.FOL.OM3RandomizedTrial ValentinaA.Andreeva1*,ClotildeLatarche2,3,SergeHercberg1,4,SergeBrianc?on2,3,PilarGalan1, EmmanuelleKesse-Guyot1 1NutritionalEpidemiologyResearchUnit,Sorbonne-Paris-Cite′,UniversityofParisXIII,FrenchInstituteofHealthandMedicalResearch,NationalInstituteofAgronomic Research,NationalConservatoryofArtsandCrafts,Bobigny,France,2UniversityHospitalCenter,DepartmentofClinicalEpidemiologyandEvaluation,Nancy,France, 3Universite′ deLorraine,Universite′ ParisDescartes,Nancy,France,4DepartmentofPublicHealth,AvicenneHospital,Bobigny,France Abstract Background: Despite growingattention tonutritionandquality oflife in cardiovascular disease survivors,the impact of dietaryfactorsaccordingtodiseasetypeortoqualityoflifedomainispoorlyunderstood.WeinvestigatedtheeffectsofB vitamin and/or n-3 fatty acid supplementation on health-related quality of life among survivors of stroke, myocardial infarction,orunstableangina. Methods: We performed ancillary analyses of the SU.FOL.OM3 trial (2003–2009; France). In total, 2,501 men (mean age=61y) and women (mean age=63y) were randomized in a 262 factorial design to: 1) 0.56mg 5-methyl- tetrahydrofolate,3mgvitaminB6,0.02mgvitaminB12;2)600mgeicosapentaenoicanddocosahexaenoicacidsina2:1 ratio;3)Bvitaminsandn-3fattyacidscombined;or4)placebo.Health-relatedqualityoflifewasevaluatedatfollow-upwith theMedicalOutcomesStudy36-ItemShortFormHealthSurvey.Datafrom2,029individualswereusedinthisanalysis. Results:After3.160.4y,noeffectsofsupplementationwitheitherBvitaminsorn-3fattyacidsonqualityoflife(physicalor mentalhealthdomains)werefound.However,participantsreceivingBvitaminshadslightlymoreactivitylimitationsdueto emotionalproblemscomparedwiththosenotreceivingBvitamins(meandifference=3.8;95%CI:0.4,7.1).Asignificant interaction of treatment by prior disease revealed an inverse association between n-3 fatty acids and vitality among