Effect of Vitamin D and Omega-3 Fatty Acids on Blood Pressure and Hypertension

维生素 D 和 Omega-3 脂肪酸对血压和高血压的影响

• 批准号: 8885276
• 负责人: JOHN P FORMAN
• 金额: $ 11.34万
• 依托单位: BRIGHAM AND WOMEN'S HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-02-04 至 2016-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8885276
• 关键词: 25-hydroxyvitamin D; Address; Affect; Aldosterone; Ancillary Study; Angiotensin II; Area; Biological; Biological Markers; Blood; Blood Pressure; Blood Vessels; Blood specimen; Calcium; Cardiovascular Diseases; Cessation of life; Cholecalciferol; Chronic Disease; Clinical assessments; Cohort Studies; Consumption; Creatinine; Development; Diet; Docosahexaenoic Acids; Dose; Double-Blind Method; E-Selectin; Eicosapentaenoic Acid; Enrollment; Excretory function; Fasting; Fatty Acids; Fish Oils; Funding; Glycosylated hemoglobin A; Health; Home environment; Hour; Human; Hypertension; Hypotension; Incidence; Individual; Inflammation; Insulin; Intake; Intercellular adhesion molecule 1; Intervention; Intervention Trial; Link; Malignant Neoplasms; Marines; Measures; Mediator of activation protein; Meta-Analysis; Nutrient; Nutritional; Observational Study; Omega-3 Fatty Acids; Parents; Participant; Pathogenesis; Phase; Placebo Control; Placebos; Plasma; Potassium; Preventive; Primary Prevention; Public Health; Randomized; Recruitment Activity; Renin; Renin-Angiotensin System; Research; Risk; Role; Running; Sample Size; Services; Sodium; Supplementation; TNF gene; Testing; United States; United States National Institutes of Health; Urine; Vitamin D; Woman; aged; attenuation; base; cost effective; design; eligible participant; falls; fasting glucose; follow-up; high risk; hypertension prevention; improved; insulin sensitivity; men; metropolitan; normotensive; prevent; randomized trial; research study; urinary

DESCRIPTION (provided by applicant): The human toll of hypertension (HTN) is staggering, and effective preventive measures are needed. Experimental studies suggest that inadequate vitamin D and I-3 fatty acid (FA) levels may be involved in the pathogenesis of HTN through multiple biological mechanisms. Observational studies have shown inverse associations of plasma 25-hydroxyvitamin D (25[OH]D) levels and dietary I-3 FA intake with blood pressure (BP) and HTN. Small intervention trials of vitamin D and fish oil rich in I-3 FA suggest possible BP-lowering effects; however, larger trials using adequately high doses of vitamin D and I-3 FA for the primary prevention of HTN are lacking. The VITamin D and OmegA-3 TriaL (VITAL), an NIH-supported, large, randomized, double-blind, placebo-controlled, 2x2 factorial trial, will test 2000 IU/day of vitamin D (as vitamin D3 [cholecalciferol]) and 1 g/day of marine I-3 FA (eicosapentaenoic acid [EPA] + docosahexaenoic acid [DHA]) supplements on incident cardiovascular disease and cancer in 20,000 multiethnic men and women with 5 years of treatment and follow-up. VITAL provides an optimal cost-effective setting to examine the effects of both interventions on changes in BP and incident HTN. Further, as this project would begin in parallel with enrollment into the parent VITAL trial, pre-randomization assessments of BP and biomarkers will be possible. In this proposed ancillary study, we will recruit a representative subcohort of 1,000 VITAL participants without baseline HTN from 5 major US metropolitan areas to conduct home-based examinations at baseline and 2 years follow-up through Examination Management Services, Inc (EMSI). We will obtain 24-hour ambulatory BP (ABP), fasting bloods, 24-hour urines, and other clinical assessments in this EMSI subcohort. We will also ascertain incident HTN cases in the overall VITAL trial. We will test the following hypotheses: (1) whether vitamin D and fish oil supplementation lowers 24-hour ABP compared to placebo in the EMSI subcohort of 1,000 participants; (2) whether vitamin D and fish oil supplementation reduces the risk of incident HTN compared to placebo among all randomized VITAL participants without baseline HTN; and (3) whether vitamin D and fish oil supplementation favorably changes HTN-related biomarkers that are putative mechanistic mediators linking vitamin D and I-3 FAs with HTN compared to placebo. This proposed study will provide definitive evidence to support or refute the potential preventive roles of vitamin D and I-3 FA on BP and the development of HTN.

描述（由申请人提供）：高血压（HTN）的人数令人震惊，需要采取有效的预防措施。实验研究表明，通过多种生物学机制，HTN的发病机理可能涉及维生素D和I-3脂肪酸（FA）水平不足。观察性研究表明，血浆25-羟基维生素D（25 [OH] D）水平和饮食I-3 FA摄入与血压（BP）和HTN的逆相关。富含I-3 FA的维生素D和鱼油的小型干预试验表明可能降低BP的作用；但是，缺乏使用足够高剂量的维生素D和I-3 FA的较大试验来预防HTN。维生素D和Omega-3试验（VIT），是NIH支持的，大的，随机的，双盲的，安慰剂对照，2x2阶乘试验，将测试2000 IU/Day的维生素D3（如维生素D3 [维生素D3 [cholecalciferol]）和1 g/day i-3 g/day i-3 faiCAICAH（eEciCaheah + epenea + epenea + epenea，酸[DHA]）在20,000名具有5年治疗和随访的男性和女性中的事件心血管疾病和癌症的补充。 Vital提供了最佳的成本效益环境，以检查两种干预措施对BP和事件HTN变化的影响。此外，由于该项目将与进入父级重要试验的入学率同时开始，因此可以对BP和生物标志物进行前随机化评估。在这项拟议的辅助研究中，我们将招募来自美国5个主要大都会地区的基线HTN的1,000名重要参与者的代表性亚酒店，以在基线上进行基于家庭考试，并通过考试管理服务（EMSI）进行2年的随访。我们将在此EMSI亚群中获得24小时的卧床BP（ABP），空腹血液，24小时尿液和其他临床评估。我们还将在总体重要试验中确定HTN病例的事件。我们将检验以下假设：（1）与EMSI亚群中的1,000名参与者相比，维生素D和鱼油补充剂与安慰剂相比是否降低了24小时ABP； （2）在没有基线HTN的所有随机重要参与者中，维生素D和鱼油补充剂是否会降低HTN的发生风险HTN的风险； （3）与安慰剂相比，维生素D和鱼油补充剂是否有利地改变了与HTN相关的生物标志物，它们是推定的机械介质，将维生素D和I-3 FAS与HTN相比，与安慰剂相比。这项拟议的研究将提供明确的证据，以支持或反驳维生素D和I-3 FA在BP和HTN的发展中的潜在预防作用。