Night-time Use of Thiazide Diuretics for Improved Reduction in Stone Risk in Stone Formers With Elevated Urine Calcium
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Change in excretion and supersaturation of urine calcium oxalate / phosphate
研究概览
简要总结
Thiazide diuretics will be more effective in lowering urine calcium excretion if taken at night as compared to the daytime. It will therefore be more effective in reducing kidney stone recurrence in nephrolithiasis patients with elevated urine calcium who are known to have increased risk of kidney stones at night time.
详细描述
The study will be divided into three phases for every single patient, investigators will study 15-20 stone formers who have previously documented elevated urine calcium excretion, with a plan to measure their urine chemistries at baseline (if they currently use thiazide diuretics, they will come off of their respective thiazide for a 7-day washout period). Investigators will ask them to collect urine samples in two 12-hour intervals: on awakening, the 1st sample starts to before supper; 2nd sample begins after dinner and extends overnight with fasting after dinner, These measurements will be used as controls. Then patients will be started back on diuretics (25mg of chlorthalidone for the primary study; pending the results this may be repeated with 25mg of hydrochlorothiazide as a second substudy) which they will take in the daytime; after a 6-day acclimation period, two 12-hour urine samples will be collected as in the washout period. For the third study period, the patients will then begin taking the thiazide after dinner. After a 6-day acclimation period, the third set of urine collections will be done.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 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
- •Patients with recurrent calcium kidney stones (at least 2 episodes) and either a higher urine calcium excretion (urine Ca >200 mg/d or > 4 mg/kg body weight) or,
- •In patients who currently take a thiazide diuretic, a history of elevated urine calcium prior to medication use;
- •Also capable of signing consent and doing 24-hour urine collections repeatedly.
排除标准
- •Patients with primary hyperparathyroidism, renal tubular acidosis, chronic kidney disease (serum creatinine > 1.5 mg/dl), inflammatory bowel disease, gout,
- •Patients taking thiazides with a history of hypertension,
- •Patients with baseline systolic blood pressure less than 110mmHg
研究组 & 干预措施
thiazide
Stone formers History of calcium containing kidney stones, hypercalciuria on previous urine tests, no kidney disease, not pregnant/lactating
干预措施: chlorthalidone (Drug)
thiazide
Stone formers History of calcium containing kidney stones, hypercalciuria on previous urine tests, no kidney disease, not pregnant/lactating
干预措施: Hydrochlorothiazide (Drug)
结局指标
主要结局
Change in excretion and supersaturation of urine calcium oxalate / phosphate
时间窗: 1 week
次要结局
未报告次要终点
研究者
David S. Goldfarb, M.D.
PI
VA New York Harbor Healthcare System