Investigations Into the Genotype and Phenotype of Unclassified Hyperoxaluria: Enteric Oxalate Absorption Study
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 114
- 试验地点
- 1
- 主要终点
- Urine oxalate measured following absorption of oral oxalate dose
研究概览
简要总结
The purpose of this study is to learn more about a condition called 'unclassified hyperoxaluria'. People with this condition have large amounts of oxalate in their urine, which can cause kidney stones and kidney failure. We do not know what causes the high level of oxalate in the urine. In this study, we will evaluate absorption of a test dose of oxalate taken orally by measuring the amount of the test dose that is eliminated in the urine. We will compare the results of affected patients to healthy volunteers.
详细描述
Participants' oxalate intake and output will be monitored and assessed over a 24 hour period. Participants will ingest a prescribed oxalate dose and urine oxalate will be monitored for the 24 hour study period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 4 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age equal to or greater than 4 years (patient must be able to void on request).
- •Have good health.
排除标准
- •Any prior history of renal disease, or hypertension
- •ALL subjects (controls and affected patients) will be asked to discontinue any diuretics, calcium supplements, H2 blockers, proton pump inhibitors or gastrointestinal motility agents for approximately one week prior to initiation of the study.
- •Subjects with GFR < 50 cc/min will be excluded.
研究组 & 干预措施
C-13 labeled oxalate
Hyperoxaluric patients
干预措施: C-13 labeled oxalate (Drug)
结局指标
主要结局
Urine oxalate measured following absorption of oral oxalate dose
时间窗: 2 years
Subjects with hyperoxaluria will be given an oral test dose of oxalate, with measurement of urine oxalate excretion over the next 24 hours.
次要结局
未报告次要终点