Mature Vinegar Prophylaxis Against Recurrent Calcium Oxalate Nephrolithiasis
China80 participantsStarted 2017-03-22
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
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Inclusion criteria
. 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;
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1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
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5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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Questions for the trial coordinator
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1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
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6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Recurrence rate of renal stone
Timeframe: 3 years
Trial details
NCT IDNCT03092908
SponsorThe First Affiliated Hospital of Guangzhou Medical University