Kidney Stones, Urolithiasis, HypocitraturiaAPULNCT04073719
Apple Cider Vinegar for the Prevention of Urinary Lithiasis (APUL)
A study testing Apple Cider Vinegar and Other Beverage in people with Kidney Stones, Urolithiasis, Hypocitraturia, run by United States Naval Medical Center, San Diego.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Kidney Stones, Urolithiasis, Hypocitraturia
- What is being tested?
- Apple Cider Vinegar and Other Beverage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2019to 31 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male and female volunteers 18-65 years old
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the detailed 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.
- Being tested
- Apple Cider Vinegar, Other Beverage
- Keywords
- Kidney Stones, Urolithiasis, Hypocitraturia, Apple Cider Vinegar
- Medical subject headings
- Kidney Calculi, Urolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Apple Cider VinegarDietary supplement
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 BeverageDietary supplement
To what degree do other high citrate beverages impact urinary citrate output.
| Study group | Role | What they receive |
|---|---|---|
| Apple Cider Vinegar + Coconut Water | Experimental | Patients will drink apple cider vinegar for 7 days. After a washout period of 2 weeks, patients will then drink coconut water for 7 days. Receives: Dietary Supplement: Apple Cider Vinegar |
| Apple Cider Vinegar + Citric Soda | Experimental | Patients will drink apple cider vinegar for 7 days. After a washout period of 2 weeks, patients will then drink citric soda for 7 days. Receives: Dietary Supplement: Apple Cider Vinegar |
| Apple Cider Vinegar + Lemonade | Experimental | Patients will drink apple cider vinegar for 7 days. After a washout period of 2 weeks, patients will then drink lemonade for 7 days. Receives: Dietary Supplement: Apple Cider Vinegar |
| Coconut Water + Apple Cider Vinegar | Experimental | Patients will drink coconut water for 7 days. After a washout period of 2 weeks, patients will then drink apple cider vinegar for 7 days. Receives: Dietary Supplement: Apple Cider Vinegar |
| Coconut Water + Citric Soda | Experimental | Patients will drink coconut water for 7 days. After a washout period of 2 weeks, patients will then drink citric soda for 7 days. Receives: Dietary Supplement: Other Beverage |
| Coconut Water + Lemonade | Experimental | Patients will drink coconut water for 7 days. After a washout period of 2 weeks, patients will then drink lemonade for 7 days. Receives: Dietary Supplement: Other Beverage |
| Citric Soda + Apple Cider Vinegar | Experimental | Patients will drink citric soda for 7 days. After a washout period of 2 weeks, patients will then drink apple cider vinegar for 7 days. Receives: Dietary Supplement: Apple Cider Vinegar; Dietary Supplement: Other Beverage |
| Citric Soda + Coconut Water | Experimental | Patients will drink citric soda for 7 days. After a washout period of 2 weeks, patients will then drink coconut water for 7 days. Receives: Dietary Supplement: Other Beverage |
| Citric Soda + Lemonade | Experimental | Patients will drink citric soda for 7 days. After a washout period of 2 weeks, patients will then drink lemonade for 7 days. Receives: Dietary Supplement: Other Beverage |
| Lemonade + Apple Cider Vinegar | Experimental | Patients will drink lemonade for 7 days. After a washout period of 2 weeks, patients will then drink apple cider vinegar for 7 days. Receives: Dietary Supplement: Apple Cider Vinegar |
| Lemonade + Coconut Water | Experimental | Patients will drink lemonade for 7 days. After a washout period of 2 weeks, patients will then drink coconut water for 7 days. Receives: Dietary Supplement: Other Beverage |
| Lemonade + Citric Soda | Experimental | Patients will drink lemonade for 7 days. After a washout period of 2 weeks, patients will then drink citric soda for 7 days. Receives: Dietary Supplement: Other Beverage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Apple Cider Vinegar Urinary Citrate Increase
Determine the change in urinary citrate levels due to the addition of apple cider vinegar to the diet
Measured: 1 week
Secondary outcomes (3)
Apple Cider Vinegar and urinary pH
Determine the effect of apple cider vinegar on urinary pH
Measured: 1 week
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)
Measured: 4 weeks
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.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2019
- Study start1 Sep 2019 (estimated)
- Primary completion31 May 2021 (estimated)
- Study completion31 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (43)Papers the sponsor has linked to this study.
- Other trials for Kidney Stones, Urolithiasis, HypocitraturiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Prospective randomized sample of 36 patients, in a nested cross over design.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- United States Naval Medical Center, San Diego
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Christine Herforth, United States Naval Medical Center, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04073719
- Sponsor's protocol ID
- NMCSD.2019.0026
- Acronym
- APUL
- Status last verified
- Aug 2019
- First submitted
- 28 Aug 2019
- Last updated
- 30 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Scales CD Jr, Smith AC, Hanley JM, Saigal CS; Urologic Diseases in America Project. Prevalence of kidney stones in the United States. Eur Urol. 2012 Jul;62(1):160-5. doi: 10.1016/j.eururo.2012.03.052. Epub 2012 Mar 31.
PubMed 22498635Pearle MS, Calhoun EA, Curhan GC; Urologic Diseases of America Project. Urologic diseases in America project: urolithiasis. J Urol. 2005 Mar;173(3):848-57. doi: 10.1097/01.ju.0000152082.14384.d7.
PubMed 15711292Johnson CM, Wilson DM, O'Fallon WM, Malek RS, Kurland LT. Renal stone epidemiology: a 25-year study in Rochester, Minnesota. Kidney Int. 1979 Nov;16(5):624-31. doi: 10.1038/ki.1979.173.
PubMed 548606Bansal AD, Hui J, Goldfarb DS. Asymptomatic nephrolithiasis detected by ultrasound. Clin J Am Soc Nephrol. 2009 Mar;4(3):680-4. doi: 10.2215/CJN.05181008. Epub 2009 Mar 4.
PubMed 19261817Bhatti UH, Duffy AJ, Roberts KE, Shariff AH. Nephrolithiasis after bariatric surgery: A review of pathophysiologic mechanisms and procedural risk. Int J Surg. 2016 Dec;36(Pt D):618-623. doi: 10.1016/j.ijsu.2016.11.025. Epub 2016 Nov 12.
PubMed 27847289Maalouf NM, Tondapu P, Guth ES, Livingston EH, Sakhaee K. Hypocitraturia and hyperoxaluria after Roux-en-Y gastric bypass surgery. J Urol. 2010 Mar;183(3):1026-30. doi: 10.1016/j.juro.2009.11.022. Epub 2010 Jan 21.
PubMed 20096421Sakhaee K. Nephrolithiasis as a systemic disorder. Curr Opin Nephrol Hypertens. 2008 May;17(3):304-9. doi: 10.1097/MNH.0b013e3282f8b34d.
PubMed 18408483Sakhaee K, Maalouf NM, Kumar R, Pasch A, Moe OW. Nephrolithiasis-associated bone disease: pathogenesis and treatment options. Kidney Int. 2011 Feb;79(4):393-403. doi: 10.1038/ki.2010.473. Epub 2010 Dec 1.
PubMed 21124301Sakhaee K. Recent advances in the pathophysiology of nephrolithiasis. Kidney Int. 2009 Mar;75(6):585-95. doi: 10.1038/ki.2008.626. Epub 2008 Dec 10.
PubMed 19078968Worcester EM, Coe FL. Clinical practice. Calcium kidney stones. N Engl J Med. 2010 Sep 2;363(10):954-63. doi: 10.1056/NEJMcp1001011. No abstract available.
PubMed 20818905Curhan GC, Taylor EN. 24-h uric acid excretion and the risk of kidney stones. Kidney Int. 2008 Feb;73(4):489-96. doi: 10.1038/sj.ki.5002708. Epub 2007 Dec 5.
PubMed 18059457Nicar MJ, Skurla C, Sakhaee K, Pak CY. Low urinary citrate excretion in nephrolithiasis. Urology. 1983 Jan;21(1):8-14. doi: 10.1016/0090-4295(83)90113-9.
PubMed 6823713Rudman D, Kutner MH, Redd SC 2nd, Waters WC 4th, Gerron GG, Bleier J. Hypocitraturia in calcium nephrolithiasis. J Clin Endocrinol Metab. 1982 Dec;55(6):1052-7. doi: 10.1210/jcem-55-6-1052.
PubMed 7130336Pak CY, Poindexter JR, Adams-Huet B, Pearle MS. Predictive value of kidney stone composition in the detection of metabolic abnormalities. Am J Med. 2003 Jul;115(1):26-32. doi: 10.1016/s0002-9343(03)00201-8.
PubMed 12867231Pak CY; New Collective Author. Citrate and renal calculi: an update. Miner Electrolyte Metab. 1994;20(6):371-7.
PubMed 7783699
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Apple Cider Vinegar for the Prevention of Urinary Lithiasis (APUL)
- ClinicalTrials.gov ID
- NCT04073719
- Acronym / sponsor ID
- APUL / NMCSD.2019.0026
- Keywords
- Kidney Stones, Urolithiasis, Hypocitraturia, Apple Cider Vinegar
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- United States Naval Medical Center, San DiegoUS federal agency
- Study start
- 1 Sep 2019 (estimated)
- Primary completion
- 31 May 2021 (estimated)
- Study completion
- 31 May 2022 (estimated)
- First posted
- 29 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 12
- Model description
- Prospective randomized sample of 36 patients, in a nested cross over design.
| Arm | Type | Receives |
|---|---|---|
| Apple Cider Vinegar + Coconut Water | Experimental | Dietary Supplement: Apple Cider VinegarPatients will drink apple cider vinegar for 7 days. After a washout period of 2 weeks, patients will then drink coconut water for 7 days. |
| Apple Cider Vinegar + Citric Soda | Experimental | Dietary Supplement: Apple Cider VinegarPatients will drink apple cider vinegar for 7 days. After a washout period of 2 weeks, patients will then drink citric soda for 7 days. |
| Apple Cider Vinegar + Lemonade | Experimental | Dietary Supplement: Apple Cider VinegarPatients will drink apple cider vinegar for 7 days. After a washout period of 2 weeks, patients will then drink lemonade for 7 days. |
| Coconut Water + Apple Cider Vinegar | Experimental | Dietary Supplement: Apple Cider VinegarPatients will drink coconut water for 7 days. After a washout period of 2 weeks, patients will then drink apple cider vinegar for 7 days. |
| Coconut Water + Citric Soda | Experimental | Dietary Supplement: Other BeveragePatients will drink coconut water for 7 days. After a washout period of 2 weeks, patients will then drink citric soda for 7 days. |
| Coconut Water + Lemonade | Experimental | Dietary Supplement: Other BeveragePatients will drink coconut water for 7 days. After a washout period of 2 weeks, patients will then drink lemonade for 7 days. |
| Citric Soda + Apple Cider Vinegar | Experimental | Dietary Supplement: Apple Cider Vinegar, Dietary Supplement: Other BeveragePatients will drink citric soda for 7 days. After a washout period of 2 weeks, patients will then drink apple cider vinegar for 7 days. |
| Citric Soda + Coconut Water | Experimental | Dietary Supplement: Other BeveragePatients will drink citric soda for 7 days. After a washout period of 2 weeks, patients will then drink coconut water for 7 days. |
| Citric Soda + Lemonade | Experimental | Dietary Supplement: Other BeveragePatients will drink citric soda for 7 days. After a washout period of 2 weeks, patients will then drink lemonade for 7 days. |
| Lemonade + Apple Cider Vinegar | Experimental | Dietary Supplement: Apple Cider VinegarPatients will drink lemonade for 7 days. After a washout period of 2 weeks, patients will then drink apple cider vinegar for 7 days. |
| Lemonade + Coconut Water | Experimental | Dietary Supplement: Other BeveragePatients will drink lemonade for 7 days. After a washout period of 2 weeks, patients will then drink coconut water for 7 days. |
| Lemonade + Citric Soda | Experimental | Dietary Supplement: Other BeveragePatients will drink lemonade for 7 days. After a washout period of 2 weeks, patients will then drink citric soda for 7 days. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Male and female volunteers 18-65 years old
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Apple Cider VinegarWill 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. | Dietary supplement | Apple Cider Vinegar + Citric Soda, Apple Cider Vinegar + Coconut Water, Apple Cider Vinegar + Lemonade, Citric Soda + Apple Cider Vinegar, Coconut Water + Apple Cider Vinegar, Lemonade + Apple Cider Vinegar |
| Other BeverageTo what degree do other high citrate beverages impact urinary citrate output. | Dietary supplement | Citric Soda + Apple Cider Vinegar, Citric Soda + Coconut Water, Citric Soda + Lemonade, Coconut Water + Citric Soda, Coconut Water + Lemonade, Lemonade + Citric Soda, Lemonade + Coconut Water |
Primary outcome
Apple Cider Vinegar Urinary Citrate Increase
Time frame: 1 week
Determine the change in urinary citrate levels due to the addition of apple cider vinegar to the diet
3 secondary outcomes
Apple Cider Vinegar and urinary pH
Time frame: 1 week
Apple Cider Vinegar Against Other Beverages
Time frame: 4 weeks
Palatability Evaluation
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2019.
- Background: PubMed 22498635Scales CD Jr, Smith AC, Hanley JM, Saigal CS; Urologic Diseases in America Project. Prevalence of kidney stones in the United States. Eur Urol. 2012 Jul;62(1):160-5. doi: 10.1016/j.eururo.2012.03.052. Epub 2012 Mar 31.
- Background: PubMed 15711292Pearle MS, Calhoun EA, Curhan GC; Urologic Diseases of America Project. Urologic diseases in America project: urolithiasis. J Urol. 2005 Mar;173(3):848-57. doi: 10.1097/01.ju.0000152082.14384.d7.
- Background: PubMed 548606Johnson CM, Wilson DM, O'Fallon WM, Malek RS, Kurland LT. Renal stone epidemiology: a 25-year study in Rochester, Minnesota. Kidney Int. 1979 Nov;16(5):624-31. doi: 10.1038/ki.1979.173.
- Background: PubMed 19261817Bansal AD, Hui J, Goldfarb DS. Asymptomatic nephrolithiasis detected by ultrasound. Clin J Am Soc Nephrol. 2009 Mar;4(3):680-4. doi: 10.2215/CJN.05181008. Epub 2009 Mar 4.
- Background: PubMed 27847289Bhatti UH, Duffy AJ, Roberts KE, Shariff AH. Nephrolithiasis after bariatric surgery: A review of pathophysiologic mechanisms and procedural risk. Int J Surg. 2016 Dec;36(Pt D):618-623. doi: 10.1016/j.ijsu.2016.11.025. Epub 2016 Nov 12.
- Background: PubMed 20096421Maalouf NM, Tondapu P, Guth ES, Livingston EH, Sakhaee K. Hypocitraturia and hyperoxaluria after Roux-en-Y gastric bypass surgery. J Urol. 2010 Mar;183(3):1026-30. doi: 10.1016/j.juro.2009.11.022. Epub 2010 Jan 21.
- Background: PubMed 18408483Sakhaee K. Nephrolithiasis as a systemic disorder. Curr Opin Nephrol Hypertens. 2008 May;17(3):304-9. doi: 10.1097/MNH.0b013e3282f8b34d.
- Background: PubMed 21124301Sakhaee K, Maalouf NM, Kumar R, Pasch A, Moe OW. Nephrolithiasis-associated bone disease: pathogenesis and treatment options. Kidney Int. 2011 Feb;79(4):393-403. doi: 10.1038/ki.2010.473. Epub 2010 Dec 1.
- Background: PubMed 19078968Sakhaee K. Recent advances in the pathophysiology of nephrolithiasis. Kidney Int. 2009 Mar;75(6):585-95. doi: 10.1038/ki.2008.626. Epub 2008 Dec 10.
- Background: PubMed 20818905Worcester EM, Coe FL. Clinical practice. Calcium kidney stones. N Engl J Med. 2010 Sep 2;363(10):954-63. doi: 10.1056/NEJMcp1001011. No abstract available.
- Background: PubMed 18059457Curhan GC, Taylor EN. 24-h uric acid excretion and the risk of kidney stones. Kidney Int. 2008 Feb;73(4):489-96. doi: 10.1038/sj.ki.5002708. Epub 2007 Dec 5.
- Background: PubMed 6823713Nicar MJ, Skurla C, Sakhaee K, Pak CY. Low urinary citrate excretion in nephrolithiasis. Urology. 1983 Jan;21(1):8-14. doi: 10.1016/0090-4295(83)90113-9.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Apple Cider Vinegar and Other Beverage in people with Kidney Stones, Urolithiasis, Hypocitraturia, run by United States Naval Medical Center, San Diego.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christine M Herfroth, MD (6195327227, christine.m.herforth.mil@mail.mil), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Apple Cider Vinegar Urinary Citrate Increase (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04073719, which also lists 43 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2019.