Pharmacological Therapy for Calcium Phosphate Urolithiasis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 2
- 主要终点
- Urinary Calcium Phosphate Saturation
研究概览
简要总结
The investigators will examine in two studies whether citric acid or potassium citrate can reduce calcium phosphate saturation in urine of Calcium Phosphate stone formers.
详细描述
We will examine in two short-term placebo-controlled cross-over metabolic studies whether citric acid or potassium citrate can reduce calcium phosphate saturation in urine of CaP stone formers.
The first study will be conducted in hypocitraturic CaP stone formers without hypercalciuria, and will compare the effects of potassium citrate, citric acid and placebo.
The second study will be conducted in hypercalciuric CaP stone formers on a thiazide diuretic who require potassium supplementation, and will compare the effects of potassium chloride alone, potassium chloride + citric acid, and potassium citrate alone. Physicochemical assays will be applied in addition to computer-based stone risk prediction programs to assess risk of stone recurrence.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hypocitraturic CaP stone formers
- •urine citrate <320mg/d
- •elevated pH as 24-hr urine pH above 6.40
- •>21 years
- •Hypercalciuric CaP stone formers
- •24hr urine calcium >250mg/d in women and >300mg/d in men prior to indapamide use
- •high pH as >6.40 in the absence of urinary tract infection
- •>21 years
排除标准
- 未提供
结局指标
主要结局
Urinary Calcium Phosphate Saturation
时间窗: 2 weeks
This variable represents a ratio of the calcium phosphate saturation in a given urine sample to the calcium phosphate saturation at the point of precipitation and hence this measure has no units.
次要结局
未报告次要终点
研究者
Naim Maalouf
Associate Professor of Medicine
University of Texas Southwestern Medical Center