Oral Calcium Supplementation, a Strategy to Reduce Kidney Stones in Crohn's Patients Living With a Small Bowel Resection
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Molar ratio of urinary calcium:oxalate in relation to the supersaturation product of calcium oxalate
研究概览
简要总结
Hospitalization for kidney stones in the Inflammatory Bowel Disease (IBD) population is common, particularly among Crohn's patients who had a small bowel resection. This patient population experiences a lifetime occurrence of kidney stone formation as high as 25% accompanied with a high rate of recurrence (the typical rate of stone formation is ~10% in the non IBD population). Giving oral calcium is used to bind oxalate in the intestine in an attempt to reduce the amount of oxalate that is absorbed into the body and to reduce urinary oxalate levels. However, there are no defined guidelines for the optimum dosing of calcium. This study's primary objective is to scientifically define an appropriate range of calcium supplementation that reduce the level of oxalate found in the urine of patients living with inflammatory bowel disease.
详细描述
The primary objective of this study is to establish optimal oral calcium supplementation in Crohn's patients who have had an ileal bowel resection. This population is at high risk for calcium oxalate kidney stones, a direct consequence of extensive gut malabsorption and enteric hyperoxaluria. The benefit of providing oral calcium in this patient population (as a means to reduce intestinal oxalate absorption) is known, however, there are no appropriate targets for calcium dosing, which is presently performed empirically or not at all. Our goal is to establish simple, safe and practical guidelines for calcium supplementation.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •a pathologically confirmed diagnosis of Crohn's disease
- •prior ileal resection with an intact colon (surgery>6 months preceding involvement in study)
- •hyperoxaluria (defined as> 48 mg (>0.5 mmol) per 24 hour urine samples.
- •Patients will not be excluded if they are known kidney stone formers.
排除标准
- •current pregnancy
- •patient's without baseline hyperoxaluria (defined as >48 mg or 0.5mmol per 24 hour urine samples)
- •patients in renal failure assessed by a GFR < 60
- •inability to provide informed consent
- •active cancer
- •hyperparathyroidism
- •hyperphosphatemia
- •<19 years of age
研究组 & 干预措施
Dietary supplement
Calcium Carbonate
干预措施: Calcium Carbonate (Dietary Supplement)
结局指标
主要结局
Molar ratio of urinary calcium:oxalate in relation to the supersaturation product of calcium oxalate
时间窗: 7 days
Molar ratio of urinary calcium:oxalate in relation to the supersaturation product of calcium oxalate will be calculated from the 24-hour urine test. The patient will take dietary calcium for 7 days and then we will evaluate their urine chemistry. Additionally, 24-hour urine collections are considered the standard for urinalysis in comparison to spot urine chemistry. The initial data, prior to calcium supplementation, will serve as the control, providing the patient's baseline risk for kidney stone formation.
次要结局
- Optimal level of Ca supplementation for prevention of stones in Crohn's patients(7 days)
研究者
Ben Chew, MD
Associate Professor
University of British Columbia