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临床试验 NCT06989320 针对肾结石，肾结石，泌尿系结石，草酸钙尿石症，肾结石，草酸钙肾结石，草酸盐尿石症，健康，健康志愿者目前招募中。请查看临床试验雷达卡片视图和 AI 发现工具了解所有详情，或在此提出任何问题。 | ||
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阿拉巴马大学伯明翰分校Endogenous Oxalate Synthesis in Idiopathic Calcium Oxalate Kidney Stone Disease 80 饮食
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临床试验NCT06989320是一项针对肾结石，肾结石，泌尿系结石，草酸钙尿石症，肾结石，草酸钙肾结石，草酸盐尿石症，健康，健康志愿者的干预性研究试验，目前试验状态为招募中。试验始于2025年5月27日，计划招募80名患者。该研究由阿拉巴马大学伯明翰分校主导，预计于2031年12月31日完成。试验数据来源于ClinicalTrials.gov，最后更新时间为2025年5月31日。
简要概括
The goal of this clinical trial study is to test if patients with idiopathic calcium oxalate kidney stones have an increased production of oxalate by the body, which would lead to increased urinary excretion of oxalate.
The study will recruit adult patients with a history of calcium oxalate kidney stones and healthy volunteers without kidney stones.
Participants will
ingest fixed diets containing low amounts of ox...
显示更多详细描述
In this study the investigators propose to measure the production of oxalate by the body (endogenous oxalate synthesis), after equilibration on a low oxalate diet (<60 mg oxalate/day, 600-800 mg calcium/day) and estimate the importance of vitamin C and glycolate metabolism to oxalate production in both Calcium Oxalate Kidney Stone patients and matched controls by oral dosings of those two substances.
Phase 1. Scree...
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Endogenous Oxalate Synthesis in Idiopathic Calcium Oxalate Kidney Stone Formers
疾病
肾结石肾结石泌尿系结石草酸钙尿石症肾结石草酸钙肾结石草酸盐尿石症健康健康志愿者其他研究标识符
- IRB300014279-OSS
- R01DK137784 (美国 NIH 拨款/合同)
NCT编号
实际开始日期
2025-05-27
最近更新发布
2025-05-31
预计完成日期
2031-12-31
计划入组人数
80
研究类型
干预性研究
试验分期 (阶段)
不适用
试验状态
招募中
关键词
oxalate synthesis
主要目的
基础研究
分配方式
非随机
干预模型
平行
盲法
无（开放性试验）
试验组/干预措施
| 参与者组/试验组 | 干预措施/治疗方法 |
|---|---|
实验性Idiopathic Calcium Oxalate Kidney Stone Patients Low oxalate fixed diets. oral glycolate and ascorbic acid administration | Low-oxalate diet and glycolate dosing Low-oxalate diet 4 days of fixed eucaloric diet with low oxalate (\<60 mg/day), normal calcium content (600-1000 mg/day) Oral glycolate dosing Oral 13C-glycolate dosing (0.5 mg/kg) Oral 13C- ascorbic acid dosing Oral 13C- ascorbic acid dosing (0.75 mg/kg) |
阳性对照Healthy non-kidney stone forming individuals Low oxalate fixed diets. oral glycolate and ascorbic acid administration | Low-oxalate diet and glycolate dosing Low-oxalate diet 4 days of fixed eucaloric diet with low oxalate (\<60 mg/day), normal calcium content (600-1000 mg/day) Oral glycolate dosing Oral 13C-glycolate dosing (0.5 mg/kg) Oral 13C- ascorbic acid dosing Oral 13C- ascorbic acid dosing (0.75 mg/kg) |
主要终点
次要终点
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Estimated endogenous oxalate synthesis (oxalate mg/day) | Basal rate of endogenous oxalate synthesis estimated by repeat fasted hourly urine collections (mg/day) | 1 day |
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
24-hour urinary oxalate excretion on low oxalate diet | mean 24-hour urinary oxalate excretion on the low oxalate diet (mg/day) | 2 days |
contribution of ascorbic acid breakdown to urinary oxalate excretion | contribution of ascorbic acid breakdown to oxalate synthesis (%) | 2 days |
参与助手
资格标准
适龄参与研究
成人, 老年人
最低年龄要求
18 Years
适龄性别
全部
接受健康志愿者
是
- age 18-80 yrs
- Body Mass Index > 18.5 kg/m2
- Normal fasting serum electrolytes on comprehensive metabolic profile
- Willing to ingest fixed diets
- Willing to stop supplements (vitamins including vitamin C, calcium (citrate or carbonate) and other minerals, herbal supplements, nutritional aids, probiotics) for 2 weeks before start and during study.
- For stone formers: first time or recurrent Calcium Oxalate stone former. Composition of most recent stone ≥ 50% calcium oxalate if available, uric acid component <20%
- Chronic Kidney Disease stage 4-5
- Primary hyperoxaluria, Enteric (secondary) hyperoxaluria
- Liver, bowel, endocrine or renal diseases (other than idiopathic Calcium Oxalate kidney stones) or any other condition that may influence the absorption, transport or urinary excretion of ions, which will compromise the interpretation of results, including: Cystic fibrosis, Celiac disease, Cystinuria, Uric acid stone former, Nephrotic syndrome, Sarcoidosis, Renal tubular acidosis, Primary hyperparathyroidism, Neurogenic bladder, Urinary diversion, Chronic diarrhea, Bariatric surgery, Inflammatory bowel disease
- Pregnancy or breast-feeding
- Incompatible dietary requirements with the study, food allergies or intolerance to any of the foods in study menus
- Active malignancy or treatment for malignancy within 12 months prior to screening
- Utilization of immunosuppressive medication
- Uncontrolled hypertension or diabetes
- Diabetes type 1
阿拉巴马大学伯明翰分校478 个活跃的临床试验可供探索- 德克萨斯大学西南医学中心284 个活跃的临床试验可供探索
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
研究责任方
Sonia Fargue, 主要研究者, Associate professor, University of Alabama at Birmingham
研究中心联系人
联系人: Sonia Fargue, PhD, 205-975-6932, [email protected]
2 位于 1 个国家/地区的研究中心
Alabama
United States, Alabama University of Alabama at Birmingham, Birmingham, Alabama, 35294, United States
Sonia Fargue, PhD, 联系人, 205-975-6932, [email protected]
Research Coordinator, 联系人, 205-934-5712, [email protected]
Sonia Fargue, PhD, 主要研究者
招募中
Texas
University of Texas South Western Medical Center, Dallas, Texas, 75390, United States
Naim Maalouf, MD, 联系人, [email protected]
Research Coordinator, 联系人, [email protected]
Naim Maalouf, MD, 主要研究者
尚未招募