Apple Cider Vinegar for the Prevention of Urinary Lithiasis (APUL)

Kidney Stones, Urolithiasis, Hypocitraturia Clinical Trial

— APUL  

Official title:

Apple Cider Vinegar for the Prevention of Urinary Lithiasis (APUL)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04073719
• Other study ID #: NMCSD.2019.0026
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2019
• Est. completion date: May 31, 2022

Study information

• Verified date: August 2019
• Source: United States Naval Medical Center, San Diego
• Contact: Christine M Herfroth, MD
• Phone: 6195327227
• Email: christine.m.herforth.mil[@]mail.mil
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to assess whether certain beverages can increase urinary citrate levels in healthy individuals with no history of kidney disease.

Description:

Higher urinary citrate levels have been shown to decrease one's risk of developing kidney stones. The study will compare apple cider vinegar, coconut water, diet citric soda and lemonade and determine which is superior at raising citrate levels. Research participants will consume two of the four drinks, each for 7 day periods, according to a prescribed regimen. Throughout the course of the study, participants will periodically provide blood draws for metabolic panels, as well as 24-hour urine samples to measure citrate levels. There will be 12 study arms, accounting for the permutations of two drinks for each patients out of four possibilities. 3 participants per arm is the goal, for a total of 36, but the recruitment aim is 50 participants, to account for dropout and noncompliance.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: May 31, 2022
• Est. primary completion date: May 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Male and female volunteers 18-65 years old

Exclusion Criteria:

• History of peptic ulcer disease or gastroparesis

• Pregnant females

• History of chronic kidney disease

• History of urolithiasis

• Currently taking medications that interfere with urinary electrolyte excretion (thiazide and loop diuretics)javascript:document.

• History of Diabetes

Related Conditions & MeSH terms

• Kidney Calculi
• Kidney Stones, Urolithiasis, Hypocitraturia
• Lithiasis
• Nephrolithiasis
• Urolithiasis

Intervention

Dietary Supplement:
• Apple Cider Vinegar
Will drinking apple cider vinegar increase urinary citrate levels to a greater degree than other beverages and which beverages produce the most significant effects compared against one another.
• Other Beverage
To what degree do other high citrate beverages impact urinary citrate output.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
United States Naval Medical Center, San Diego

References & Publications (42)

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* Note: There are 42 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Apple Cider Vinegar Urinary Citrate Increase	Determine the change in urinary citrate levels due to the addition of apple cider vinegar to the diet	1 week
Secondary	Apple Cider Vinegar and urinary pH	Determine the effect of apple cider vinegar on urinary pH	1 week
Secondary	Apple Cider Vinegar Against Other Beverages	Compare the effect of apple cider vinegar on urinary citrate with that of known citrate-rich beverages (lemonade, citrus based soda, coconut water)	4 weeks
Secondary	Palatability Evaluation	Compare the palatability of apple cider vinegar and other known citrate-rich beverages (lemonade, citrus based soda, coconut water). Patients will keep daily log whwere they can free write any side effects (from palatability perspective and otherwise). At the end of the study a 2 question survery (Likert scale format) will be filled in which participants will answer the liklihood of their willingness to consume the beverage daily for the prevention of kidney stones.	4 weeks