MEASUREMENT OF OPIOIDS, DIETARY FACTORS, AND GENETICS IN THE FAZST/IDEAL STUDIES

FAZST/IDEAL 研究中阿片类药物、饮食因素和遗传学的测量

• 批准号: 9791481
• 负责人: MICHAEL TSAI
• 金额: $ 181.86万
• 依托单位: UNIVERSITY OF MINNESOTA
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-09-24 至 2020-09-23
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9791481
• 关键词: Acids; Address; All-Trans-Retinol; Antidepressive Agents; Biological Assay; Biological Markers; Birth Rate; Blood; Calcium; Clinical; Collection; Contractor; Cotinine; Couples; Creatinine; DNA; Data; Diet; Dietary Factors; Double-Blind Method; Drug Prescriptions; Embryo; Endocrine; Endocrine system; Enrollment; Fatty acid glycerol esters; Female; Fertility Study; Folic Acid; Genetic; Genetic Polymorphism; Glycosylated hemoglobin A; Immunoglobulin A; Intervention Studies; Length; Life Style; Live Birth; MTHFR gene; Measures; Metabolic Marker; Metabolism; Micronutrients; Opioid; Outcome; Participant; Persons; Placebos; Pregnancy; Pregnancy loss; Questionnaires; Randomized; Research; Role; Sampling; Seminal fluid; Serum; Testing; Treatment outcome; Urine; Visit; Vitamin D; Vitamin D-Binding Protein; Vitamins; Whole Blood; Work; Zinc; Zinc supplementation; assisted reproduction; diet and exercise; folic acid metabolism; follow-up; infertility treatment; inflammatory marker; male; novel; primary outcome; randomized placebo controlled trial; recruit; repository; telomere

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

叶酸和锌补充剂试验 (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夫妇的男性伴侣补充叶酸和锌对精液质量和活产的主要结果的影响。男性参与者被平等地（1:1）随机分配到活性研究补充剂（5 毫克叶酸和 30 毫克元素锌）或匹配的安慰剂。研究干预从随机分组开始持续 6 个月，男性参与者在基线、第 2、4 和 6 个月完成了现场研究访问，其中包括血液、尿液和精液采集。女性伴侣提供基线生物样本和问卷数据，并通过图表抽象来跟踪临床结果。试招募于2017年12月完成，共有2372对夫妇入组。饮食、运动和生活方式的影响 (IDEAL) 生育力研究涉及对一部分女性伴侣进行额外详细的随访。 大型生物样本库可用于分析，并为测试多种假设提供良好的平台。此任务顺序用于分析 FAZST/IDEAL 研究中存储的生物样本。这项任务旨在测量锌和叶酸代谢标记物、炎症标记物、异前列腺素、内分泌系统标记物和代谢标记物，这将使 DIPHR 能够结合 FAZST/IDEAL 研究中已收集的广泛数据回答新的研究问题