Mature Vinegar Prophylaxis Against Recurrent Calcium Oxalate Nephrolithiasis - a Prospective Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Recurrence rate of renal stone
研究概览
简要总结
Kidney stones are one of the most common disorders of the urinary tract and cause a great deal of morbidity and economic loss. Because of the high recurrence rate, researchers are interested in finding medicinal therapies to prevent kidney stone recurrence. Vinegar is consumed worldwide as a food condiment and preservative. The mature vinegar, also called black vinegar, is an inky-black vinegar aged for a malty, woody, and smoky flavor. It is popular in the north of China as a dipping sauce, particularly for dumplings.
Some studies promote vinegar for its medicinal properties, as a tonic which may lower blood pressure and cholesterol level. Our national epidemiological data in China showed that consumed more mature vinegar was associated with decreased risk of kidney stones formations. Furthermore, our previous in vivo study found that mature vinegar could inhibit renal calcium oxalate crystals formation in rat model. These findings inspire us to clarify the nephrolithiasis prevention effect of mature vinegar in a clinical trial. In this study, investigators would like to examine the efficacy of mature vinegar prophylaxis for preventing recurrent calcium oxalate nephrolithiasis.
详细描述
Background: Kidney stones are one of the most common disorders of the urinary tract and cause a great deal of morbidity and economic loss. Because of the high recurrence rate, researchers are interested in finding medicinal therapies to prevent kidney stone recurrence. Vinegar is consumed worldwide as a food condiment and preservative. The mature vinegar, also called black vinegar, is an inky-black vinegar aged for a malty, woody, and smoky flavor. It is popular in the north of China as a dipping sauce, particularly for dumplings.
Some studies promote vinegar for its medicinal properties, as a tonic which may lower blood pressure and cholesterol level. Our national epidemiological data in China showed that consumed more mature vinegar was associated with decreased risk of kidney stones formations. Furthermore, our previous in vivo study found that mature vinegar could inhibit renal calcium oxalate crystals formation in rat model (unpublished). These findings inspire us to clarify the nephrolithiasis prevention effect of mature vinegar in a clinical trial. In this study, investigators would like to examine the efficacy of mature vinegar prophylaxis for preventing recurrent calcium oxalate nephrolithiasis.
Methods: A prospective randomized, controlled, single-center clinical trial will be performed at the First Affiliated Hospital of Guangzhou Medical University from March 2017 to March 2022.
Intervention: 80 subjects are randomly assigned in a 1:1 ratio to receive mature vinegar or placebo. The sequence of randomization is computer generated and are performed by the hospital's pharmacy service, whoever administer 5 ml mature vinegar (Brand: Ninghuafu) three times a day and placebo as liquid of the same type in identical bottles. The subjects, the attending urologist, and the investigators are not aware of study arm assignments until the final assessment of outcome.
From the beginning of invention, participants will be scheduled to receive a brief (< 10 min) individual telephone contact once per month and weekly text messages. The telephone contacts are conducted by intervention staff and followed a standard script. Text message are provided once per week and are used to remind participants in invention group of drinking mature vinegar.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and female > 18 years;
- •History of recurrent nephrolithiasis, with one or more calcium oxalate or mixed (calcium oxalate and phosphate, calcium oxalate and uric acid) stone formation over the last 5 years; the stone had been removed completely confirmed by CT scan;
- •No current treatment for the prevention of recurrent stones except for the advice to increase water intake;
- •Residence in the area of Guangzhou, China;
- •Written informed consent
排除标准
- •Obstructive uropathy, chronic urosepsis, renal failure (serum creatinine > 177 umol/L), renal tubular acidosis, primary hyperparathyroidism, primary hyperoxaluria, bowel resection, inflammatory bowel disease, pure uric acid and cystine stones, medullary sponge kidney;
- •Active peptic ulcer disease, gastric esophagus reflux; Past history of peptic ulcer disease;
- •Participants who had a known the vinegar effect for stone formation;
- •Concomitant clinical conditions that might affect completion of the study or jeopardize data interpretation.
研究组 & 干预措施
Control group
Administer 5 ml placebo (purified water) three times a day.
干预措施: placebo (water) (Dietary Supplement)
Intervention group
Administer 5 ml mature vinegar (Brand: Ninghuafu) three times a day.
干预措施: mature vinegar (Dietary Supplement)
结局指标
主要结局
Recurrence rate of renal stone
时间窗: 3 years
The first recurrence of a symptomatic renal stone or the presence of asymptomatic renal stone or the presence of a radiographically identified stone.
次要结局
- serum calcium(3 years)
- serum uric acid(3 years)
- serum creatinine(3 years)
- 24-h urine compositions(3 years)
研究者
Guohua Zeng
Vice President
The First Affiliated Hospital of Guangzhou Medical University