Acid-Base Compensation in Chronic Kidney Disease: Measurement and Physiologic Impact
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Change in ambulatory blood pressure
研究概览
简要总结
The purpose of this study is to evaluate changes in urine net acid excretion, blood pressure and body chemistry that occur when the dietary acid load is lowered by using a drug/dietary supplement similar to baking soda. This may be important for patients with kidney disease because they may have difficulty removing all of the dietary acid load from the body in the urine. Participants with and without kidney disease will be recruited. Each participant will be fed a controlled diet for one week with sodium bicarbonate and for one week without sodium bicarbonate to evaluate these changes. The investigators will also determine if the effect of dietary acid load reduction is different in patients with kidney disease compared to those without kidney disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •estimated glomerular filtration rate ≥30 ml/min/1.73m2
- •serum bicarbonate 20-28 mEq/L
排除标准
- •diabetes mellitus
- •uncontrolled hypertension or recent (<3 weeks) titration of blood pressure medications
- •clinically significant volume overload on screening physical examination
- •selected medical conditions other than kidney disease and hypertension (active cancer, chronic liver failure, moderate to severe COPD, New York Heart Association class 2 or greater congestive heart failure, obstructive sleep apnea requiring nightly continuous positive airway pressure, solid organ transplant)
- •use of alkali supplementation
- •body mass index <18.5 or >40 kg/m2
- •ideal body weight <45.5 kg
- •anemia at screening (hematocrit <29% in participants with kidney disease or <33% in healthy participants)
- •pregnancy or breastfeeding
- •allergies, intolerance or unwillingness to consume foods or supplement provided in feeding menu
- •serum calcium less than 8.6 mg/dl on screening laboratories
研究组 & 干预措施
Controlled diet first
In this arm participants will first consume a controlled diet plus added table salt (sodium chloride) for one week. They will then consume an identical controlled diet plus sodium bicarbonate for one week. Sodium bicarbonate will be dosed as 2,600 mg divided three times daily if ideal body weight is <70 kg or 3,250 mg divided three times daily if ideal body weight is ≥70 kg. Added table salt will match the sodium content of the sodium bicarbonate dose (i.e. 31 or 39 mEq/day).
干预措施: Sodium bicarbonate (Drug)
Controlled diet first
In this arm participants will first consume a controlled diet plus added table salt (sodium chloride) for one week. They will then consume an identical controlled diet plus sodium bicarbonate for one week. Sodium bicarbonate will be dosed as 2,600 mg divided three times daily if ideal body weight is <70 kg or 3,250 mg divided three times daily if ideal body weight is ≥70 kg. Added table salt will match the sodium content of the sodium bicarbonate dose (i.e. 31 or 39 mEq/day).
干预措施: Controlled diet (Other)
Sodium bicarbonate first
In this arm participants will first consume a controlled diet plus sodium bicarbonate for one week. They will then consume an identical controlled diet plus added table salt (sodium chloride) for one week. Sodium bicarbonate will be dosed as 2,600 mg divided three times daily if ideal body weight is <70 kg or 3,250 mg divided three times daily if ideal body weight is ≥70 kg. Added table salt will match the sodium content of the sodium bicarbonate dose (i.e. 31 or 39 mEq/day).
干预措施: Sodium bicarbonate (Drug)
Sodium bicarbonate first
In this arm participants will first consume a controlled diet plus sodium bicarbonate for one week. They will then consume an identical controlled diet plus added table salt (sodium chloride) for one week. Sodium bicarbonate will be dosed as 2,600 mg divided three times daily if ideal body weight is <70 kg or 3,250 mg divided three times daily if ideal body weight is ≥70 kg. Added table salt will match the sodium content of the sodium bicarbonate dose (i.e. 31 or 39 mEq/day).
干预措施: Controlled diet (Other)
结局指标
主要结局
Change in ambulatory blood pressure
时间窗: Measured at the end of each week of intervention (i.e. one week apart)
Change in mean 24 hour systolic and diastolic blood pressure comparing the end of the controlled feeding plus sodium bicarbonate period to the end of the controlled feeding plus table salt period.
Change in urine net acid excretion
时间窗: Urine net acid excretion will be measured at three timepoints over approximately 3 weeks (i.e. 2 weeks of intervention plus one week baseline data collection/run-in)
Change in urine net acid excretion comparing the end of the controlled feeding plus sodium bicarbonate period to the end of the controlled feeding plus table salt period.
次要结局
- Change in clinic blood pressure(Clinic blood pressure will be measured at multiple timepoints over approximately 3 weeks (i.e. 2 weeks of intervention plus one week baseline data collection/run-in))
- Change in plasma nitric oxide metabolites(Measured at the end of each week of intervention (i.e. one week apart) up to 3 weeks)