Lowering Salt Intake in Chronic Kidney Disease: A Pilot Randomized Crossover Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Primary Outcome: Change in volume status (intracellular, extracellular volume, and total body water) as measured by BIA using both whole body and segmental techniques
研究概览
简要总结
ABSTRACT
Background:
It is well recognized that excess dietary salt intake plays a major role in the development of hypertension. Chronic Kidney Disease (CKD) is associated with excess salt and water retention (excess volume) which is associated with hypertension.
Hypotheses:
Hypothesis 1:
Dietary salt restriction will improve volume status in subjects with CKD stages 3-4 as assessed by Bioelectrical Impedance Analysis (BIA).
Hypothesis 2:
Dietary salt restriction will result in improved blood pressure control in patients with CKD stages 3-4.
Hypothesis 3:
Dietary salt restriction will decrease albuminuria in patients with CKD stages 3-4.
Patients and Trial Design: This randomized crossover pilot study is designed to assess the effect of salt restriction on volume status in patients with CKD stages 3 and 4.
Subjects will be randomized to a treatment order: (1) 4 weeks of salt restriction of <85 mmol sodium per day, a 2 week washout period, and 4 weeks of usual salt diet, OR (2) 4 weeks of usual diet, 2 weeks washout, and 4 weeks of salt restriction. Patients will receive dietary counseling in person at each study visit and at weekly intervals by phone calls from study dieticians. At weeks 0, 4, 6 and 10, patients will undergo assessments for (i) physical examination with assessments for weight, blood pressure, pulse, anthropometrics and a standardized clinical assessment of volume status. (ii) volume status using bioelectrical impedance analysis (BIA) (iii) 24-hour urine testing for, albumin, creatinine and aldosterone Every 2 weeks throughout the study, a 24-hour urine sodium will be measured for compliance, and serum electrolytes will be assessed for safety.
Data Analysis: BIA measurements in the low salt group will be compared with the regular diet group using the standard linear model analysis for 2x2 crossover trials. Additionally, 24-hour ambulatory and static blood pressure and 24-hour urine aldosterone levels will be compared between the two groups.
Future Implications: A significant reduction in the degree of volume expansion (as assessed by BIA) and blood pressure as a result of a salt restricted diet would have implications for renal and cardiovascular protection and would warrant confirmation by a larger randomized trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals eligible to participate in this study must meet all of the following criteria:
- •Willing and able to provide written, signed informed consent after the nature of the study has been explained, and prior to any research-related procedures.
- •Age ≥ 18 years and ≤ 85 years.
- •Willing and able to comply with all study procedures.
- •Patients with eGFR of 20 to 60 ml/min/173m2 by the abbreviated (4-variable) MDRD equation and a relatively stable clinical course.
- •Sitting systolic blood pressure ≥ 100 mmHg prior to study entry (to exclude people at risk from hypotension from dietary salt reduction).
排除标准
- •Individuals who meet any of the following exclusion criteria will not be eligible to participate in the study:
- •Recent acute illness (≤1 month). Minor ailments such as a recovered common cold or allergic rhinitis would not be considered as exclusion criteria but would be left to the site PI's discretion.
- •Recent hospitalization (≤1 month) unless clearly for a minor elective procedure unlikely to interfere with BIA measurements. The final decision will be left to the site PI's discretion.
- •Any psychological condition (including alcoholism) that could interfere with the patient's ability to comply with the study protocol.
- •Subjects with baseline 24-hour urinary sodium excretion ≤100 mmol/day.
- •Amputation of a limb other than fingers or toes.
- •Pacemaker, defibrillator, implantable pump, artificial joint, pins, plates or other types of metal objects in the body (other than dental fillings).
- •Coronary stents or metal suture material in the heart.
- •Use of any investigational product or investigational medical device within 30 days prior to screening, or requirement for any investigational agent prior to completion of all scheduled study assessments.
- •Weight over 300 pounds (limitation for examination table).
- •Pregnancy or lactation.
- •Patients with kidney diseases known to be associated with salt wasting (see above).
- •Patients with atrial fibrillation as ambulatory blood pressure measurements may not be accurate in this setting.
- •Any condition that, in the view of the PI, places the subject at high risk of poor treatment compliance or of not completing the study.
结局指标
主要结局
Primary Outcome: Change in volume status (intracellular, extracellular volume, and total body water) as measured by BIA using both whole body and segmental techniques
时间窗: 12 Weeks
次要结局
未报告次要终点
研究者
Rajiv Saran
MD, MS, MRCP, Associate Professor
University of Michigan