Calcium Nephrolithiasis: Clinical Characteristics and Nutritional Determinants
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 210
- 试验地点
- 1
- 主要终点
- Normalization of urinary calcium levels
研究概览
简要总结
Randomized clinical trial comparing water therapy plus low-salt diet to water therapy alone in patients affected by idiopathic calcium nephrolithiasis.
Treatment duration: three months Primary end-point: correction of hypercalciuria Main inclusion criteria: calcium stone formers with idiopathic hypercalciuria, with at least one stone expelled and analyzed by infrared spectrophotometry; presence of hypercalciuria (>300 mg/day in males and >200 mg/day in females); 18-65 years.
Main exclusion criteria: primary hyperparathyroidism, primary hyperoxaluria, enteric hyperoxaluria, bowel resection, inflammatory bowel disease, renal tubular acidosis, sarcoidosis, sponge kidney, hyperthyroidism, use of hypercalciuric drugs such as Vitamin D, acetazolamide, anti-epileptic drugs
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Main inclusion criteria:
- •idiopathic calcium stone formers, with at least one stone expelled and analyzed by infrared spectrophotometry; presence of hypercalciuria (>300 mg/day in males and 20 mg/day in females);
- •18-65 years.
排除标准
- •primary hyperparathyroidism,
- •primary hyperoxaluria,
- •enteric hyperoxaluria,
- •bowel resection,
- •inflammatory bowel disease,
- •renal tubular acidosis,
- •sarcoidosis, sponge kidney,
- •hyperthyroidism,
- •use of hypercalciuric drugs such as Vitamin D,
- •acetazolamide,
- •anti-epileptic drugs
研究组 & 干预措施
water therapy alone
干预措施: Water therapy alone (Behavioral)
Low salt diet plus water therapy
干预措施: Low salt diet (Behavioral)
结局指标
主要结局
Normalization of urinary calcium levels
次要结局
- Change in urinary stone risk factors (e.g. urinary calcium, oxalate and sodium excretion); blood pressure reduction