Phase III Study of 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
- 2 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Urinary calcium level after treatment with ergocalciferol will be compared with the pre-treatment level. The primary outcome is the change in urinary calcium excretion.
研究概览
简要总结
The investigators hypothesize that a 3 month course of vitamin D supplementation to treat 25(OH)D deficiency in stone formers with high levels of 24-hour urinary calcium will not increase urinary calcium excretion by greater than 10%.
详细描述
We plan to conduct a clinic-based interventional study of 30 patients followed at Brigham and Women's Hospital with history of nephrolithiasis, urinary calcium excretion between 200 and 400 mg/day, and 25-vitamin D deficiency (defined as serum level ≤ 25ng/ml). The intervention is oral ergocalciferol 50,000 IU per week for 8 weeks [1], and each participant will serve as his own control. The outcome is the change in urinary calcium excretion. The planned study duration is 3 months. We 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 ≤ 25ng/ml) within 3 months of enrollment
- •24-hour urinary calcium excretion > 199 mg/day and < 400 mg/day (measured less than 6 months prior to study enrollment)
排除标准
- •Non-Caucasian
- •Women of child-bearing age (age < 50)
- •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 2 months
- •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)
研究组 & 干预措施
ergocalciferol
After signing informed consent, all participants who meet the study criteria will receive ergocalciferol 50,000 IU weekly for 8 weeks. After completing the ergocalciferol course, participants will take a maintenance dose of cholecalciferol 1,000 IU daily.
干预措施: vitamin D (ergocalciferol) (Drug)
结局指标
主要结局
Urinary calcium level after treatment with ergocalciferol will be compared with the pre-treatment level. The primary outcome is the change in urinary calcium excretion.
时间窗: 1-2 years
次要结局
未报告次要终点
研究者
Jie Tang, MD,M.Sc
Jie Tang, M.D., M.Sc.
Brigham and Women's Hospital