MEASUREMENT OF OPIOIDS, DIETARY FACTORS, AND GENETICS IN THE FAZST/IDEAL STUDIES
MEASUREMENT OF OPIOIDS, DIETARY FACTORS, AND GENETICS IN THE FAZST/IDEAL STUDIES
批准号:
9791481
负责人:
MICHAEL TSAI
金额:
$181.86万
依托单位:
依托单位国家:
美国
项目类别:
财政年份:
2018
资助国家:
美国
项目状态:
已结题
起止时间:
2018-09-24 至 2020-09-23
关键词:
AcidsAddressAll-Trans-RetinolAntidepressive AgentsBiological AssayBiological MarkersBirth RateBloodCalciumClinicalCollectionContractorCotinineCouplesCreatinineDNADataDietDietary FactorsDouble-Blind MethodDrug PrescriptionsEmbryoEndocrineEndocrine systemEnrollmentFatty acid glycerol estersFemaleFertility StudyFolic AcidGeneticGenetic PolymorphismGlycosylated hemoglobin AImmunoglobulin AIntervention StudiesLengthLife StyleLive BirthMTHFR geneMeasuresMetabolic MarkerMetabolismMicronutrientsOpioidOutcomeParticipantPersonsPlacebosPregnancyPregnancy lossQuestionnairesRandomizedResearchRoleSamplingSeminal fluidSerumTestingTreatment outcomeUrineVisitVitamin DVitamin D-Binding ProteinVitaminsWhole BloodWorkZincZinc supplementationassisted reproductiondiet and exercisefolic acid metabolismfollow-upinfertility treatmentinflammatory markermalenovelprimary outcomerandomized placebo controlled trialrecruitrepositorytelomere
中文摘要
叶酸和锌补充试验(FAZST)是一项多中心、双盲、随机安慰剂对照试验,旨在评估寻求辅助生殖的男性伴侣补充叶酸和锌对试验主要结果精液质量和活产的影响。男性参与者平均随机(1:1),要么服用活性研究补充剂(5毫克叶酸和30毫克元素锌的组合),要么服用相应的安慰剂。研究干预从随机化开始持续了6个月,男性参与者在基线、2个月、4个月和6个月完成了亲自研究访问,包括血液、尿液和精液收集。女性伴侣提供基线生物标本和问卷数据,通过图表抽象跟踪临床结果。试验招募于2017年12月完成,共招募了2372对夫妇。饮食、运动和生活方式对生育的影响(IDEAL)研究对一部分女性伴侣进行了额外的详细随访。
英文摘要
The Folic Acid and Zinc Supplementation Trial (FAZST) is a multi-center, double-blind, randomized placebo-controlled trial to assess the effects of follc acid and zinc supplementation among male partners of couples seeking assisted reproduction, on the trial's primary outcomes of semen quality and live birth. Male participants were randomized equally (1:1) either to active study supplement (combined 5 mg folic acid and 30 mg elemental zinc) or to matching placebo. The study intervention continued for 6 months from randomization, and male participants completed in-person study visits, which included blood, urine, and semen collection, at baseline, 2, 4, and 6 months. Female partners provided biospecimens at baseline and questionnaire data, and clinical outcomes were followed through chart abstraction. Trial recruitment was completed in December 2017, with a total of 2372 couples enrolled. The Impact of Diet, Exercise and Lifestyle (IDEAL) Fertility Study involves additional detailed follow-up on a subset of the female partners.
A large biospecimen repository is available for analysis and offers a good platform for testing multiple hypotheses. This task order is for the analysis of stored biospecimens in the FAZST/IDEAL studies. The work of this task order to measure zinc and markers of folate metabolism, inflammatory markers, lsoprostanes, endocrine system markers, and metabolic markers will allow DIPHR to answer novel research questions in conjunction with the extensive data already collected in the FAZST/IDEAL studies
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