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临床试验/NCT07408076
NCT07408076尚未招募1 期

Sodium Bicarbonate as an Alternative to Potassium Citrate for Kidney Stones

University of California, Los Angeles6 个研究点 分布在 3 个国家目标入组 30 人开始时间: 2026年2月1日最近更新:
干预措施

试验速览

阶段
1 期
状态
尚未招募
入组人数
30
试验地点
6
主要终点
Change in 24-Hour Urinary Citrate Excretion from 24-Hour Urine Collection

研究概览

简要总结

Kidney stones affect 1 in every 11 people in the US each year. In patients with kidney stones who are prescribed medications for stone management, only 30.2% are adherent to a medication regime and even fewer, only 13.4 % are adherent with citrate medications.

Prescription potassium citrate can be expensive for many patients, leading to non-compliance. Sodium bicarbonate is a potential medication alternative that is cheaper and can potentially alkalinize the urine and/or decrease the risk of future kidney stones. However, efficacy of alternatives to potassium potassium citrate are not well studied.

This study seeks to evaluate sodium bicarbonate and assess its ability to alkalinize urine in a cohort of patients with kidney stones and compare this to prescription potassium citrate.

详细描述

Kidney stones affect 1 in every 11 people in the United States each year. A recurrence rate of 50% at 10 years highlights the importance of metabolic management, which has shown to be effective at decreasing the recurrence of stone disease. Specialty guidelines have recommended that clinicians offer pharmacologic therapy to recurrent stone formers. However, among kidney stone patients prescribed medication for stone management, only 30.2% are adherent to a medication regimen and even fewer, only 13.4%, are adherent with citrate medications.

Prescription potassium citrate (Kcit) can be cost-prohibitive for many patients, leading to non-compliance. The combination of the effectiveness of medication with the prohibitory cost of the prescriptions has led to the exploration of treatment alternatives which promise to alkalinize the urine and/or decrease the risk of future kidney stones, including sodium bicarbonate. However, the efficacy of these alternatives in comparison to Kcit are not well studied and often include other alkali equivalents.

A short-term study with limited sample size suggests sodium bicarbonate to be a viable alternative to Kcit. Our goal is to evaluate sodium bicarbonate and assess its ability to alkalinize urine in a cohort of stone-forming patients and compare this to prescription Kcit.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult >18 years of age
  • History of nephrolithiasis
  • One 24h urine collections within one year of enrollment with hypocitraturia.
  • Patients currently utilizing or considering use of Kcit for stone prevention

排除标准

  • Individuals with known metabolic disorders
  • Individuals with other known causes of nephrolithiasis
  • Anyone who, in the opinion of the PI, is unfit or unsuitable to participate in the study

研究组 & 干预措施

Sodium Bicarbonate -> Potassium Citrate

Experimental

Receives 1 week of sodium bicarbonate, then 1 week of potassium citrate after washout.

干预措施: Potassium Citrate (Drug)

Sodium Bicarbonate -> Potassium Citrate

Experimental

Receives 1 week of sodium bicarbonate, then 1 week of potassium citrate after washout.

干预措施: Sodium Bicarbonate (Drug)

Potassium Citrate -> Sodium Bicarbonate

Experimental

1 week of potassium citrate first, then sodium bicarbonate after a washout.

干预措施: Potassium Citrate (Drug)

Potassium Citrate -> Sodium Bicarbonate

Experimental

1 week of potassium citrate first, then sodium bicarbonate after a washout.

干预措施: Sodium Bicarbonate (Drug)

结局指标

主要结局

Change in 24-Hour Urinary Citrate Excretion from 24-Hour Urine Collection

时间窗: 14 days

Change in 24-hour urinary citrate excretion measured from 24-hour urine collections obtained at baseline and after intervention. To determine if sodium bicarbonate is not significantly worse than potassium citrate by more than a clinically acceptable margin of -10 Unit: mg/day

次要结局

  • Change in Urine pH Measured from 24-Hour Urine Collection(14 days)
  • Change in 24 hour Urinary Ammonia Excretion from 24 Hour Urine Collection(14 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kymora Scotland, MD, PhD

MD, PhD

University of California, Los Angeles

研究点 (6)

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