NCT03092908

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 22, 2017

Completed
Same day until next milestone

Study Start

First participant enrolled

March 22, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 28, 2017

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

July 3, 2018

Status Verified

June 1, 2018

Enrollment Period

4.8 years

First QC Date

March 22, 2017

Last Update Submit

June 29, 2018

Conditions

Nephrolithiasis

Keywords

calcium oxalatenephrolithiasisMature vinegarprophylaxis

Outcome Measures

Primary Outcomes (1)

  • Recurrence rate of renal stone

    The first recurrence of a symptomatic renal stone or the presence of asymptomatic renal stone or the presence of a radiographically identified stone.

    3 years

Secondary Outcomes (4)

  • 24-h urine compositions

    3 years

  • serum calcium

    3 years

  • serum creatinine

    3 years

  • serum uric acid

    3 years

Study Arms (2)

Control group

PLACEBO COMPARATOR

Administer 5 ml placebo (purified water) three times a day.

Dietary Supplement: placebo (water)

Intervention group

EXPERIMENTAL

Administer 5 ml mature vinegar (Brand: Ninghuafu) three times a day.

Dietary Supplement: mature vinegar

Interventions

mature vinegarDIETARY_SUPPLEMENT

Administer 5 ml mature vinegar (Brand: Ninghuafu) three times a day.

Intervention group
placebo (water)DIETARY_SUPPLEMENT

Administer 5 ml placebo (water) three times a day.

Control group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510120, China

RECRUITING

MeSH Terms

Conditions

Nephrolithiasis

Interventions

Water

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrolithiasisMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

HydroxidesAlkaliesInorganic ChemicalsAnionsIonsElectrolytesOxidesOxygen Compounds

Central Study Contacts

Guohua Zeng, Ph.D. ＆ M.D.

CONTACT

+8613802916676gzgyzgh@vip.sina.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Vice President

Study Record Dates

First Submitted

March 22, 2017

First Posted

March 28, 2017

Study Start

March 22, 2017

Primary Completion

December 31, 2021

Study Completion

December 31, 2022

Last Updated

July 3, 2018

Record last verified: 2018-06

Locations

CN(1)