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

补充钾对血压的随机摄入反应试验

• 批准号: 10504816
• 负责人: Joshua David Bundy
• 金额: $ 27.93万
• 依托单位: TULANE UNIVERSITY OF LOUISIANA
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-03-10 至 2027-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10504816
• 关键词: Address; Adherence; Adult; Age; Albumins; Area; Blinded; Blood Pressure; Cardiometabolic Disease; Cardiovascular Diseases; Catalogs; Centers of Research Excellence; Chronic Disease; Clinical; Clinical Research; Clinical Trials; Data; Diastolic blood pressure; Dietary Intervention; Dietary Potassium; Dietary Sodium; Dietary intake; Disease Outcome; Dose; Double-Blind Method; Engineering; Excretory function; Financial Hardship; Goals; Hour; Human; Hypertension; Intake; Intention; Intervention; Investigation; Knowledge; Measures; Mediating; Medicine; Napping; Obesity; Oral; Participant; Placebo Control; Placebos; Population; Potassium; Prevention; Prevention Guidelines; Prevention approach; Primary Prevention; Public Health; Race; Randomized; Randomized Controlled Trials; Recommendation; Reporting; Research; Research Personnel; Research Project Grants; Risk Factors; Risk Reduction; Safety; Scheme; Societies; Sodium; Subgroup; Supplementation; Testing; Training; Translational Research; United States National Academy of Sciences; Update; Urine; age effect; arm; base; blood pressure reduction; cardiometabolic risk; cardiovascular disorder prevention; cardiovascular disorder risk; cardiovascular effects; cardiovascular risk factor; comparative efficacy; design; dietary; dietary guidelines; dosage; eligible participant; epidemiology study; follow-up; hypertension prevention; hypertension treatment; improved; metropolitan; mortality; novel; placebo group; primary outcome; recruit; response; secondary outcome; sex; treatment arm; treatment effect; trial design; urinary

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.

项目总结/摘要 高血压是心血管疾病（CVD）和全因死亡率的主要可预防风险因素， 这是一个巨大的社会负担。预防和治疗高血压（BP）， 包括1期高血压，对于减少全球CVD负担至关重要。既往随机 对照试验表明，补充钾可以降低血压。然而，这些试验只比较了 与安慰剂相比，单剂量补钾（主要为60 mmol/天）对 BP.补充钾和血压之间缺乏摄入反应证据， 无法建立预防和治疗高血压的最佳钾摄入水平。的 本试验的目的是评价补钾与 1期高血压患者的血压。主要结果将是收缩压与基线的差异 至12周随访。次要结局将包括舒张压; 24小时和 夜间收缩压和舒张压;以及其他CVD风险因素。不同年龄治疗效果的一致性， 将评估性别、种族、中心性肥胖和基线膳食钠和钾摄入量。这将是一 随机、双盲、安慰剂对照、摄入-反应试验，采用4组平行设计。使用 分层、区组随机化方案，合格受试者将被分配至安慰剂组或3种钾中的1种 补充组中，0、30、60或90 mmol/天（0、1173、2346或3519 mg/天）的额外补充 口服钾12周。研究参与者、研究者和临床工作人员， 收集研究数据时，将对干预分配设盲。该试验具有>90%的统计功效来检测 钾补充与血压之间的摄入-反应关系，假设每增加30 mmol/天（1173 mg/天）钾在12周内使收缩压额外降低2 mmHg，超过 安慰剂我们将招募208名1期高血压（未经治疗）研究参与者（每组n=52 收缩压130-139和舒张压<90 mm Hg）。资格 受试者将随机接受安慰剂或3种补钾干预措施之一的治疗， 12周将在基线、随访6周和12周时测量血压和其他心脏代谢风险因素- 起来将按照意向性比较治疗组间基线至第12周收缩压的差异， 治疗分析这项研究是新颖的，因为它是第一个随机对照试验，以测试摄入反应 补充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。 重要性，因为它将确定钾补充剂降低血压的最佳水平， 1级高血压的成年人。这些信息可用于制定预防糖尿病的饮食指南。 和治疗高血压。此外，它将使研究项目负责人获得专业知识， 设计和进行随机对照试验，并帮助他过渡到研究独立。