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临床试验/NCT05389995
NCT05389995进行中(未招募)不适用

Assessing the Effects of a Commercial Lemonade Beverage and Potassium Citrate on Urinary Stone Risk Factors

Northwestern University1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2022年8月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
10
试验地点
1
主要终点
urine citrate levels

研究概览

简要总结

To define the effect of crystal light, potassium citrate, or both on urinary stone risk factors in patients with a history of stone and hypocitraturia/low pH

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 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Men and women between age 18-80 years
  • Willing to follow experimental protocol
  • Willing to complete 24-hour urine collections (three total)
  • Willing to sign the informed consent form
  • Completed Litholink Collection with blood work with results
  • a. hypocitraturia OR aciduria i. Hypocitraturics must meet definition of < 450 mg/day for men < 550 mg/day for women.
  • b. Low urine pH must be less than 5.6 c. potassium, BUN, creatinine, eGFR and hemoglobin A1c within normal limits

排除标准

  • Patients with severe hypocitraturia < 200 mg/day (men or women)
  • Patients with hyperkalemia, uncontrolled diabetes, chronic kidney disease, adrenal insufficiency, delayed gastric emptying (or drug induced delayed gastric emptying), peptic ulcer disease, or active UTI
  • Patients with distal renal tubular acidosis or medication induced RTA (e.g. carbonic anhydrase inhibitor, topiramate)
  • Members of vulnerable patient populations
  • Allergies to ingredients in crystal light
  • Patients lacking decisional capacity

研究组 & 干预措施

Potassium citrate

Active Comparator

干预措施: Potassium citrate (Drug)

Crystal light

Active Comparator

干预措施: Crystal light (Drug)

Crystal light + potassium citrate

Active Comparator

干预措施: Potassium citrate + crystal light (Drug)

结局指标

主要结局

urine citrate levels

时间窗: Day 7 of week 5

24 hour urine collection

次要结局

未报告次要终点

研究者

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

Amy Krambeck

Director of the Endourology/Stone Division

Northwestern University

研究点 (1)

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