The Effect of Vitamin D Repletion on Urinary Calcium Excretion in Kidney Stone Formers With Vitamin D Deficiency and High Urinary Calcium
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 20
- 主要终点
- Changes in urinary calcium excretion measured by timed urine collection
研究概览
简要总结
Examine the effect of nutritional vitamin D repletion on urinary calcium excretion and kidney stone burden in calcium kidney stone formers
详细描述
The investigators plan to conduct a clinic-based interventional study of 50 patients followed at Miriam Hospital Kidney Stone Clinic with history of nephrolithiasis, urinary calcium excretion between 150 and 400 mg/day, and 25-vitamin D deficiency/insufficiency (defined as serum level ≤ 30ng/ml). The intervention is oral ergocalciferol 50,000 IU per week for 12 weeks (repletion course). After that, the same repletion course will be repeated if serum 25-vitamin D remains ≤ 30ng/ml or drops to ≤ 30ng/ml anytime during the study. Otherwise, a maintenance dose of cholecalciferol 1,000 IU daily or ergocalciferol 50,000 IU monthly will be prescribed for the rest of the study. Each participant will serve as his own control. The outcome is the change in urinary calcium excretion and stone burden assessed by renal ultrasound. The planned study duration is 12 months. The investigators will have greater than 95% power to detect a 10% increase in 24-hour urinary calcium.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •History of nephrolithiasis
- •25(OH)D deficiency (defined as serum level ≤ 30ng/ml) within 3 months of enrollment
- •24-hour urinary calcium excretion > 150 mg/day and < 400 mg/day (measured less than 2 months prior to study enrollment)
排除标准
- •Known uric acid, cystine, or struvite stone disease
- •Hypercalcemia (serum calcium >10.4 mg/dl within the past 12 months)
- •Gross hematuria within the past 6 months
- •Acute stone event within the past 1 month
- •Recent stone intervention within the past 1 month
- •Suspected or known secondary causes of hypercalciuria such as primary hyperparathyroidism, sarcoidosis, hyperthyroidism, or malignancy (except non-melanoma skin cancer)
- •Addition or dose change of medicines potentially affecting urinary calcium since enrollment 24-hour urine collection (including diuretics, magnesium supplements, potassium supplements, potassium citrate, and vitamin D supplementation)
- •Pregnancy
研究组 & 干预措施
Intervention
Nutritional vitamin D repletion and maintenance
干预措施: Nutritional vitamin D repletion and maintenance (Dietary Supplement)
结局指标
主要结局
Changes in urinary calcium excretion measured by timed urine collection
时间窗: Baseline and 12 months
Examine changes in urine calcium excretion at the end of the 12month study. Urinary calcium excretion are measured by 24-hour urine collections for calcium (mg per day), and the differences are the changes of 24-hour urine calcium (mg per day) between those measured at month 12 and at the enrollment
次要结局
- Changes in kidney stone burden measured by ultrasound(Baseline and 12 months)
研究者
Jie Tang
Associate Professor
Brown University