50 Participants Needed

Oxalate and Citrate Drink for Kidney Stones

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

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.12345

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.12678

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.12579

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.
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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
2Treatment groups
Experimental Treatment
Group I: Non-kidney stone formersExperimental Treatment1 Intervention
25 non-stone-forming subjects will be enrolled in this arm.
Group II: Kidney stone formersExperimental Treatment1 Intervention
25 stone-forming subjects will be enrolled in this arm.

Find a Clinic Near You

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

References

Changes in urinary parameters after oral administration of potassium-sodium citrate and magnesium oxide to prevent urolithiasis. [2019]
Citrate and renal calculi. [2013]
Potassium-magnesium citrate is an effective prophylaxis against recurrent calcium oxalate nephrolithiasis. [2019]
Physicochemical action of potassium-magnesium citrate in nephrolithiasis. [2013]
Effects of lemon-tomato juice consumption on crystal formation in the urine of patients with calcium oxalate stones: A randomized crossover clinical trial. [2023]
Chronopharmacological studies on potassium citrate treatment of oxalocalcic urolithiasis. [2019]
Alkali Citrate Content of Common Over-the-Counter and Medical Food Supplements. [2023]
[Therapeutic use of potassium citrate]. [2022]
Potassium citrate vs. hydrochlorothiazide to reduce urinary calcium excretion in calcium oxalate stone patients with hypercalciuria: a prospective randomized study. [2022]
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