Double-Blind, Randomised Placebo-Controlled Study to Determine the Effect of Beetroot Juice on Reducing Blood Pressure in Hypertensive Adults With Autosomal Dominant Polycystic Kidney Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 4
- 主要终点
- Change in Clinic Systolic and Diastolic Blood Pressure From Baseline to 4 Weeks (End of Study)
研究概览
简要总结
People with autosomal dominant polycystic kidney disease (ADPKD) develop high blood pressure and kidney disease. Previous studies have shown that a commonly occurring chemical, nitric oxide (NO), is reduced in ADPKD, and may contribute, in part, to high blood pressure in this condition. Nitrate is found in high concentrations naturally in beetroots, and increases NO. The aim of this study is to determine if beetroot juice reduces blood pressure in hypertensive people with ADPKD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Autosomal Dominant Polycystic Kidney Disease
- •Age > 18 years old
- •Estimated Glomerular Filtration Rate (eGFR) > 30 mL/min/1.73m2
- •Treatment with at least one anti-hypertensive
排除标准
- •Inability to provide Informed Consent
- •Labile, unstable, uncontrolled hypertension and/or changes in BP treatment 28 days prior to the screening visit
- •Non-compliance with study procedures and/or daily BP measurements during the screening period
- •Medical conditions or treatments that might interfere with the generation of NO metabolites or the primary endpoint (e.g. nitrate drugs; cigarette smoking; unwilling to stop using antiseptic mouthwash; severe, uncontrolled hypercholesterolemia; pregnancy or post-partum and lactating)
- •Any serious or other medical conditions that might interfere with follow-up or stability of blood pressure (e.g. current active malignancies; uncontrolled diabetes mellitus with elevated HbA1c > 10%)
- •Dislike of taste of beetroot juice
- •Allergy to beetroot
- •Enrolled in other clinical trials
结局指标
主要结局
Change in Clinic Systolic and Diastolic Blood Pressure From Baseline to 4 Weeks (End of Study)
时间窗: 4 weeks
Change in systolic and diastolic blood pressure over two time points - from readings taken at baseline (visit 1) compared with readings taken at 4 weeks (which was the end of the study; visit 3)
次要结局
- Average Change in Daily Home Systolic and Diastolic Blood Pressure Per Week, Over 4 Weeks(4 weeks)
- Urinary Albumin to Creatinine Ratio at Baseline and at 4 Weeks (End of Study)(4 weeks)
- Change in Salivary Nitric Oxide Metabolite Levels From Baseline to 4 Weeks (End of the Study)(4 weeks)
- Change in Serum Nitric Oxide Metabolite Levels From Baseline to 4 Weeks (End of the Study)(4 weeks)
- Serum Asymmetric Dimethylarginine at Baseline and at 4 Weeks (End of the Study)(4 weeks)
研究者
Gopala K. Rangan
Nephrologist
Western Sydney Local Health District