Citrate for Kidney Stones

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Chicago

Must not be taking: Diuretics, Alkali supplements

Disqualifiers: Uric acid stones, Chronic kidney disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 1 day

24 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

If you are taking diuretic medication or alkali supplements, you will need to stop them for the duration of the study.

What data supports the effectiveness of the drug potassium citrate for kidney stones?

Research shows that potassium citrate is effective in reducing the formation of kidney stones. In one study, patients taking potassium citrate had a 96% reduction in new stone formation compared to those on conservative treatments. Additionally, potassium citrate increases urinary citrate and pH, which helps prevent stone formation. ^{1 2 3 4 5}

Is potassium citrate safe for humans?

Potassium citrate is generally considered safe when used at therapeutic doses, with good tolerance reported in patients. Some mild changes in blood chemistry may occur, but no significant adverse effects have been noted in the studies. ^{1 5 6 7 8}

How does the drug potassium citrate differ from other treatments for kidney stones?

Potassium citrate is unique because it helps prevent kidney stones by increasing citrate levels in the urine, which inhibits the formation of calcium stones. Unlike some other treatments, it can be taken with meals without losing effectiveness and may also have additional benefits like supporting bone health and reducing stone fragments after certain procedures. ^{1 8 9 10 11}

What is the purpose of this trial?

This is a single-center study that aims to learn more about how two compounds found in food, oxalate and citrate, interact in the body and may influence a person's chances of forming kidney stones. The study will examine changes in urinary oxalate and citrate levels after participants consume potassium citrate.

Eligibility Criteria

This trial is for individuals who have had kidney stones or are healthy without any history of kidney issues. Participants will be studied to understand how their bodies handle certain compounds related to kidney stone formation.

Inclusion Criteria

I am between 18-70 years old and have had at least one calcium kidney stone.

Exclusion Criteria

I have had kidney stones made of uric acid, cysteine, or struvite.

History of severe acid-base abnormality, very low (<100mg/day) or very high (>1500mg/day) urine citrate

NSF and SF with extreme levels of urine citrate will be excluded from this small initial study to reduce heterogeneity and remove focus from the extremes of citrate levels.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive a potassium citrate load and undergo urine and serum measurements over six hours

1 day

1 visit (in-person)

Follow-up

Participants are monitored for changes in urine oxalate and citrate levels after treatment

1-2 weeks

Treatment Details

Interventions

• Potassium Citrate

Trial Overview The study focuses on the response of urinary oxalate and citrate levels after consuming potassium citrate. It aims to determine if this can influence the likelihood of developing kidney stones.

Participant Groups

Group I: Kidney stone formers Experimental Treatment 1 Intervention

12 stone-forming subjects will be enrolled in this arm.

Group II: Control cohort Experimental Treatment 1 Intervention

12 non-stone-forming subjects will be enrolled in this arm.

Who Is Running the Clinical Trial?

University of Chicago

Lead Sponsor

Trials

1,086

Recruited

844,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Findings from Research

Potassium citrate is an effective treatment for managing various types of kidney stones, including calcium stones associated with renal tubular acidosis and hypocitraturic calcium oxalate nephrolithiasis.

It also helps in treating uric acid stones, demonstrating its broad utility in stone disease management, particularly for patients with specific underlying conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Citrate and renal calculi. Pak, CY.[2013]

Potassium citrate therapy significantly reduced new stone formation in patients with mild to moderately severe stone disease, achieving a remission rate of 96% (from 0.52 to 0.02 stones per patient per year, p < 0.001).

In contrast, conservative measures or placebo trials only decreased new stone formation by 54% (from 0.54 to 0.25 stones per patient per year), indicating that potassium citrate provides a more effective treatment beyond standard conservative approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative efficacy of "specific" potassium citrate therapy versus conservative management in nephrolithiasis of mild to moderate severity. Preminger, GM., Harvey, JA., Pak, CY.[2019]

In a study involving five calcium oxalate stone formers, the ingestion of minimum doses of potassium citrate significantly increased citraturia and crystallization inhibitory capacity in urine samples.

The most effective timing for taking potassium citrate was after dinner, suggesting that this method could help reduce the risk of kidney stone formation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chronopharmacological studies on potassium citrate treatment of oxalocalcic urolithiasis. Grases, F., Conte, A., March, JG., et al.[2019]

In a study of 9 patients with incomplete distal renal tubular acidosis, oral potassium citrate therapy significantly increased urinary pH and citrate levels while decreasing urinary calcium, which helps prevent kidney stone formation.

Over a mean treatment period of 34 months, none of the patients developed new kidney stones, demonstrating the long-term efficacy of potassium citrate in managing calcium nephrolithiasis associated with this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevention of recurrent calcium stone formation with potassium citrate therapy in patients with distal renal tubular acidosis. Preminger, GM., Sakhaee, K., Skurla, C., et al.[2022]

In a study of 15 patients treated with granulated potassium citrate for one month, significant biochemical changes were observed, including improvements in serum potassium, creatinine, and urinary pH, citrate, and potassium levels.

The treatment was well tolerated, confirming that potassium citrate is an effective and user-friendly option for preventing oxalocalcium kidney stones.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Granulated potassium citrate in the prevention of calcium oxalate lithiasis]. Campoy Martínez, P., Arrabal Martín, M., Quintero Rodríguez, R., et al.[2013]

In a study of 313 children on the ketogenic diet for epilepsy, those who received potassium citrate (Polycitra K) had a significantly lower incidence of kidney stones (2.0%) compared to those who did not receive the supplement (10.5%).

Starting potassium citrate supplementation at the onset of the ketogenic diet resulted in an even lower kidney stone incidence of 0.9%, demonstrating its effectiveness in preventing kidney stones by alkalinizing urine without reported adverse effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Empiric use of potassium citrate reduces kidney-stone incidence with the ketogenic diet. McNally, MA., Pyzik, PL., Rubenstein, JE., et al.[2021]

Potassium citrate is effective in preventing the formation and relapse of certain types of kidney stones, with a one-year remission rate of 70-75% in patients treated for stone disease.

It is generally safe when used at therapeutic doses, causing only mild transient metabolic alkalosis and no significant changes in blood biochemical parameters, while effectively reducing urine calcium and increasing oxalate calcium phosphate excretion.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Therapeutic use of potassium citrate]. Zmonarski, SC., Klinger, M., Puziewicz-Zmonarska, A., et al.[2022]

Many over-the-counter supplements contain more citrate than advertised, with Moonstone® powder showing the highest citrate content per serving (63.9 mEq), which could help prevent kidney stone recurrence.

While Moonstone offers the most citrate, it is more expensive compared to other products like NOW® potassium citrate, which is the least costly option ($0.04/10 mEq alkali citrate), highlighting the need to consider both efficacy and cost when choosing a citrate supplement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Alkali Citrate Content of Common Over-the-Counter and Medical Food Supplements. Dai, JC., Maalouf, NM., Hill, K., et al.[2023]

In a study of 8 pediatric patients with distal renal tubular acidosis (RTA), potassium citrate at a dosage of 4 mEq/kg/d effectively corrected most urinary abnormalities associated with nephrolithiasis, particularly reducing elevated urinary saturation for calcium oxalate.

The study found that while potassium citrate normalized several urinary ratios, the elevated urinary saturation for calcium phosphate could not be corrected, indicating that while potassium citrate is beneficial, it may not address all urinary issues in distal RTA.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dosage of potassium citrate in the correction of urinary abnormalities in pediatric distal renal tubular acidosis patients. Domrongkitchaiporn, S., Khositseth, S., Stitchantrakul, W., et al.[2013]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Citrate and renal calculi. [2013]

2. United States pubmed.ncbi.nlm.nih.gov

Comparative efficacy of "specific" potassium citrate therapy versus conservative management in nephrolithiasis of mild to moderate severity. [2019]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Chronopharmacological studies on potassium citrate treatment of oxalocalcic urolithiasis. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Prevention of recurrent calcium stone formation with potassium citrate therapy in patients with distal renal tubular acidosis. [2022]

5. Spain pubmed.ncbi.nlm.nih.gov

[Granulated potassium citrate in the prevention of calcium oxalate lithiasis]. [2013]

6. United States pubmed.ncbi.nlm.nih.gov

Empiric use of potassium citrate reduces kidney-stone incidence with the ketogenic diet. [2021]

7. Australia pubmed.ncbi.nlm.nih.gov

Potassium-sodium citrate prevents the development of renal microcalculi into symptomatic stones in calcium stone-forming patients. [2019]

8. Poland pubmed.ncbi.nlm.nih.gov

[Therapeutic use of potassium citrate]. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Alkali Citrate Content of Common Over-the-Counter and Medical Food Supplements. [2023]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Citrate and renal calculi: an update. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Dosage of potassium citrate in the correction of urinary abnormalities in pediatric distal renal tubular acidosis patients. [2013]