Oxalate and Citrate Drink 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, Severe acid-base abnormality, others

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

Compensation: Varies

Number of Visits: 2

50 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 treatment for kidney stones?

Research shows that potassium-magnesium citrate can help prevent the recurrence of calcium oxalate kidney stones by increasing urinary citrate and magnesium, which are known to inhibit stone formation. Additionally, potassium citrate has been effective in managing various types of kidney stones, including those associated with renal tubular acidosis and uric acid. ^{1 2 3 4 5}

Is the Oxalate and Citrate Drink safe for humans?

Potassium citrate, a component of the drink, is generally considered safe when used at therapeutic doses, although it may cause mild, temporary changes in body chemistry. It is usually not recommended for people with certain conditions like urinary tract infections or advanced kidney failure. ^{1 2 6 7 8}

How does the oxalate and citrate drink treatment for kidney stones differ from other treatments?

The oxalate and citrate drink is unique because it combines citrate, which helps prevent stone formation, with oxalate, potentially offering a novel approach to managing kidney stones compared to standard potassium citrate therapy. This drink may provide a more accessible and possibly cost-effective alternative to traditional medications. ^{1 2 5 7 9}

What is the purpose of this trial?

This is a single-center study that aims to earn more about how two different compounds found in food, oxalate and citrate, may affect a person's chances of forming kidney stones.

Eligibility Criteria

This trial is for adults aged 18-70 who either have a history of calcium-based kidney stones or no history at all (controls). Participants should have normal urine oxalate levels. Those with a history of non-calcium stones, severe acid-base issues, or extreme urine citrate levels cannot join.

Exclusion Criteria

You have a history of very high or very low levels of citrate in your urine or severe acid-base imbalance.

I cannot stop taking my diuretic medication or alkali supplements for the study.

You have a history of certain types of kidney stones.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Pre-study Preparation

Participants discontinue certain supplements and medications, complete a 24-hour urine collection and food frequency questionnaire at home

1 week

Study Day

Participants consume a 360mg oral sodium oxalate load and undergo urine and blood sampling over 6 hours

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Citrate
• Oxalate

Trial Overview The study investigates the effects of two dietary compounds, oxalate and citrate, on the likelihood of developing kidney stones. Participants will consume a special drink containing sodium oxalate during an all-day visit to the research clinic.

Participant Groups

Group I: Non-kidney stone formers Experimental Treatment 1 Intervention

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

Group II: Kidney stone formers Experimental Treatment 1 Intervention

25 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+

Findings from Research

The combination of potassium-sodium citrate (KNa-Cit) and magnesium oxide (MgO) significantly increases urinary excretion of citrate, magnesium, and potassium in both healthy individuals and patients with calcium oxalate stones, suggesting enhanced inhibition of stone formation.

In patients with recurrent calcium oxalate stones, this combination not only increased beneficial urinary parameters but also reduced oxalate levels by 66.5%, indicating a potential for improved management of stone recurrence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Changes in urinary parameters after oral administration of potassium-sodium citrate and magnesium oxide to prevent urolithiasis. Kato, Y., Yamaguchi, S., Yachiku, S., et al.[2019]

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]

In a study of 64 patients over 3 years, potassium-magnesium citrate significantly reduced the recurrence of calcium oxalate kidney stones, with only 12.9% of patients forming new stones compared to 63.6% in the placebo group.

The treatment lowered the risk of stone recurrence by 85%, demonstrating its efficacy in preventing kidney stones even after accounting for various confounding factors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Potassium-magnesium citrate is an effective prophylaxis against recurrent calcium oxalate nephrolithiasis. Ettinger, B., Pak, CY., Citron, JT., et al.[2019]

Potassium-magnesium citrate significantly increased urinary pH and citrate levels compared to potassium citrate, suggesting it may be more effective in preventing kidney stones by reducing the saturation of calcium oxalate.

In a study involving five normal subjects and five patients with calcium nephrolithiasis, potassium-magnesium citrate therapy led to a greater reduction in undissociated uric acid and a significant increase in urinary magnesium, indicating enhanced urinary biochemistry for stone prevention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physicochemical action of potassium-magnesium citrate in nephrolithiasis. Pak, CY., Koenig, K., Khan, R., et al.[2013]

In a study involving 22 patients with calcium oxalate stones, the addition of lemon-tomato juice to their diet significantly reduced urine optical density, indicating a lower risk of stone formation compared to consuming milk alone.

The urine calcium-creatinine ratio was also lower after consuming lemon-tomato juice, suggesting that this dietary intervention may effectively decrease key risk factors for calcium oxalate stone recurrence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of lemon-tomato juice consumption on crystal formation in the urine of patients with calcium oxalate stones: A randomized crossover clinical trial. Gopala, SK., Joe, J., Chandran, J.[2023]

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]

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]

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]

In a study of 80 patients with calcium oxalate stones and hypercalciuria, potassium citrate (K-CIT) was found to significantly increase urinary citrate levels and effectively reduce calcium excretion, similar to hydrochlorothiazide (HCT).

Both K-CIT and HCT treatments led to significant reductions in 24-hour urine calcium levels, but K-CIT showed a greater increase in citrate excretion, suggesting it may be a beneficial option for preventing stone recurrence in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Potassium citrate vs. hydrochlorothiazide to reduce urinary calcium excretion in calcium oxalate stone patients with hypercalciuria: a prospective randomized study. Solak, V., Gökce, Mİ., Yaman, Ö.[2022]

References

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

Changes in urinary parameters after oral administration of potassium-sodium citrate and magnesium oxide to prevent urolithiasis. [2019]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Citrate and renal calculi. [2013]

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

Potassium-magnesium citrate is an effective prophylaxis against recurrent calcium oxalate nephrolithiasis. [2019]

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

Physicochemical action of potassium-magnesium citrate in nephrolithiasis. [2013]

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

Effects of lemon-tomato juice consumption on crystal formation in the urine of patients with calcium oxalate stones: A randomized crossover clinical trial. [2023]

6. Netherlands pubmed.ncbi.nlm.nih.gov

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

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

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

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

[Therapeutic use of potassium citrate]. [2022]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Potassium citrate vs. hydrochlorothiazide to reduce urinary calcium excretion in calcium oxalate stone patients with hypercalciuria: a prospective randomized study. [2022]