A Randomized Intake-Response Trial of Potassium Supplementation on Blood Pressure

项目摘要/摘要 高血压是心血管疾病(CVD)和全因死亡的主要可预防危险因素， 在世界范围内，这是一个巨大的社会经济负担。预防和治疗高血压， 包括第一阶段高血压，对于减轻全球心血管疾病负担至关重要。以前的随机化 对照试验表明，补钾可降低血压。然而，这些试验只比较了 单剂量补钾(多数为60 mmo1/d)与安慰剂的疗效比较 BP。补钾和血压之间缺乏摄取-反应证据，导致了 无法确定预防和治疗高血压的最佳钾摄入量水平。这个 本试验的目的是评价补钾和补钾之间的摄入量-反应关系。 成人1期高血压患者的血压。主要结果将是收缩压与基线的差值。 随机组随访期为12周。次要结果将包括舒张压；24小时和 夜间收缩压和舒张压；以及其他心血管疾病危险因素。治疗效果按年龄的一致性， 将评估性别、种族、中心性肥胖以及基线膳食钠和钾摄入量。这将是一个 随机、双盲、安慰剂对照、摄入量-反应试验，采用4臂平行设计。使用 分层的随机分组方案，符合条件的参与者将被分配给安慰剂或1/3的钾盐 补充手臂，每天补充0、30、60或90毫摩尔(0、1173、2346或3519毫克/天) 钾的口服将持续12周。研究参与者、研究人员和临床工作人员 收集研究数据将对干预任务视而不见。此试验具有90%的统计能力来检测 补钾与血压之间的摄入量-反应关系 每天1173毫克)钾在12周内使收缩压额外降低2毫米汞柱，超过 安慰剂。我们将招募208名患有1期高血压(未经治疗)的研究参与者(每组52人) 收缩压130-139和舒张压90毫米汞柱)。合资格 参与者将随机接受安慰剂治疗或3种补钾干预措施中的一种 12周。血压和其他心脏代谢危险因素将在基线、6周和12周后进行测量- 向上。治疗组的基线血压与12周收缩压的差异将按意向进行比较- 处理分析。这项研究是新颖的，因为它是第一个测试摄入反应的随机对照试验。 补钾对人体血压的影响。这项研究具有重要的临床和公共卫生意义 意义重大，因为它将确定降低血压的最佳补钾水平 患有1期高血压的成年人。这些信息可用于制定预防糖尿病的饮食指南。 以及高血压的治疗。此外，它将使研究项目负责人在以下方面获得专门知识 设计和实施随机对照试验，并帮助他过渡到研究独立性。

PROJECT SUMMARY/ABSTRACT Hypertension is the leading preventable risk factor for cardiovascular disease (CVD) and all-cause mortality, worldwide, and is a huge financial burden to society. Prevention and treatment of high blood pressure (BP), including stage 1 hypertension, is crucial for reducing the global burden of CVD. Previous randomized controlled trials have shown that potassium supplementation lowers BP. However, these trials only compared the efficacy of a single dosage of potassium supplementation (mostly 60 mmol/day) compared with placebo on BP. The lack of intake-response evidence between potassium supplementation and BP has resulted in an inability to establish the optimal level of potassium intake for hypertension prevention and treatment. The objective of this trial is to evaluate the intake-response relationship between potassium supplementation and BP in adults with stage 1 hypertension. The primary outcome will be the difference in systolic BP from baseline to 12-week follow-up among randomized groups. Secondary outcomes will include diastolic BP; 24-hour and nighttime systolic and diastolic BP; and other CVD risk factors. The consistency of treatment effects by age, sex, race, central adiposity, and baseline dietary sodium and potassium intake will be evaluated. This will be a randomized, double-blind, placebo-controlled, intake-response trial with a 4-arm, parallel design. Using a stratified, blocked randomization scheme, eligible participants will be assigned to placebo or 1 of 3 potassium supplementation arms in which 0, 30, 60, or 90 mmol/day (0, 1173, 2346, or 3519 mg/day) of additional potassium will be administered orally for 12 weeks. The study participants, investigators, and clinical staff who collect the study data will be blinded to intervention assignments. This trial has >90% statistical power to detect an intake-response relationship between potassium supplementation and BP, assuming each additional 30 mmol/day (1173 mg/day) potassium decreases systolic BP by an additional 2 mm Hg over 12 weeks, beyond placebo. We will recruit 208 study participants (n=52 in each group) with stage 1 hypertension (untreated systolic BP 130-139 and diastolic BP <90 mm Hg) from the greater New Orleans metropolitan area. Eligible participants will be randomized to treatment with placebo or 1 of 3 potassium supplementation interventions for 12 weeks. BP and other cardiometabolic risk factors will be measured at baseline, 6, and 12 weeks of follow- up. Difference in baseline to 12-week systolic BP across the treatment arms will be compared per intention-to- treat analysis. This study is novel because it is the first randomized controlled trial to test the intake-response effects of potassium supplementation on BP in humans. The study has important clinical and public health significance because it will identify the optimal level of potassium supplementation for BP lowering among adults with stage 1 hypertension. This information can be used to develop dietary guidelines for the prevention and treatment of hypertension. Additionally, it will allow the Research Project Leader to gain expertise in the design and conduct of randomized controlled trials, and aid in his transition to research independence.