Clinical Trial: Mature Vinegar Prophylaxis Against Recurrent Calcium Oxalate Nephrolithiasis

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Mature Vinegar Prophylaxis Against Recurrent Calcium Oxalate Nephrolithiasis - a Prospective Randomized Controlled Trial

Brief 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.


Detailed Summary:

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previous in vivo study found that mature vinegar could inhibit renal calcium oxalate crystals formation in rat model (unpublished).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, double-blind, 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 urol
Sponsor: The First Affiliated Hospital of Guangzhou Medical University

Current Primary Outcome: Recurrence rate of renal stone [ Time Frame: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 24-h urine compositions [ Time Frame: 3 years ]
    Change in 24-h urine compositions (calcium excretion, oxalate excretion, etc.)
  • serum calcium [ Time Frame: 3 years ]
    Change in serum calcium
  • serum creatinine [ Time Frame: 3 years ]
    Change in serum creatinine
  • serum uric acid [ Time Frame: 3 years ]
    Change in serum uric acid


Original Secondary Outcome: Same as current

Information By: The First Affiliated Hospital of Guangzhou Medical University

Dates:
Date Received: March 22, 2017
Date Started: March 22, 2017
Date Completion: December 31, 2022
Last Updated: March 31, 2017
Last Verified: March 2017