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
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
- 否
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
Amy Krambeck
Director of the Endourology/Stone Division
Northwestern University
研究点 (1)
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