Oxalate and Citrate Drink for Kidney Stones
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Chicago
Must not be taking: Diuretics, Alkali supplements
Disqualifiers: Uric acid stones, Severe acid-base abnormality, others
No Placebo Group
Trial Summary
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.
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?
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
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.Inclusion Criteria
I am between 18-70 years old, have never had a kidney stone, and my urine oxalate is normal.
I am between 18 and 70 years old and have had at least one calcium-based kidney stone.
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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Trial 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 (Other)
- Oxalate (Other)
Trial OverviewThe 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
Research Locations NearbySelect from list below to view details:
University of Chicago Medical CenterChicago, IL
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Who Is Running the Clinical Trial?
University of ChicagoLead Sponsor
References
Changes in urinary parameters after oral administration of potassium-sodium citrate and magnesium oxide to prevent urolithiasis. [2019]To examine urinary parameters among normal individuals and patients with calcium oxalate (CaOx) stones after oral administration of potassium-sodium citrate (KNa-Cit) and magnesium oxide (MgO). Urinary citrate and magnesium have been known as the inhibitors of CaOx stone formation. Supplementation with potassium-magnesium citrate prevents the recurrence of CaOx stones.
Citrate and renal calculi. [2013]Potassium citrate is a new and exciting therapeutic approach which has considerably broadened our capability for the medical control of stone disease. The discussion summarizes the data supporting utility of potassium citrate in the management of renal tubular acidosis with calcium stones, hypocitraturic calcium oxalate nephrolithiasis ('idiopathic', or secondary to chronic diarrheal syndrome or thiazide therapy) and uric acid lithiasis with or without calcium stones.
Potassium-magnesium citrate is an effective prophylaxis against recurrent calcium oxalate nephrolithiasis. [2019]We examined the efficacy of potassium-magnesium citrate in preventing recurrent calcium oxalate kidney calculi.
Physicochemical action of potassium-magnesium citrate in nephrolithiasis. [2013]Effect of potassium-magnesium citrate on urinary biochemistry and crystallization of stone-forming salts was compared with that of potassium citrate at same dose of potassium in five normal subjects and five patients with calcium nephrolithiasis. Compared to the placebo phase, urinary pH rose significantly from 6.06 +/- 0.27 to 6.48 +/- 0.36 (mean +/- SD, p less than 0.0167) during treatment with potassium citrate (50 mEq/day for 7 days) and to 6.68 +/- 0.31 during therapy with potassium-magnesium citrate (containing 49 mEq K, 24.5 mEq Mg, and 73.5 mEq citrate per day). Urinary pH was significantly higher during potassium-magnesium citrate than during potassium citrate therapy. Thus, the amount of undissociated uric acid declined from 118 +/- 61 mg/day during the placebo phase to 68 +/- 54 mg/day during potassium citrate treatment and, more prominently, to 41 +/- 46 mg/day during potassium-magnesium citrate therapy. Urinary magnesium rose significantly from 102 +/- 25 to 146 +/- 37 mg/day during potassium-magnesium citrate therapy but not during potassium citrate therapy. Urinary citrate rose more prominently during potassium-magnesium citrate therapy (to 1027 +/- 478 mg/day from 638 +/- 252 mg/day) than during potassium citrate treatment (to 932 +/- 297 mg/day). Consequently, urinary saturation (activity product) of calcium oxalate declined significantly (from 1.49 x 10(-8) to 1.03 x 10(-8) M2) during potassium-magnesium citrate therapy and marginally (to 1.14 x 10(-8) M2) during potassium citrate therapy.(ABSTRACT TRUNCATED AT 250 WORDS)
Effects of lemon-tomato juice consumption on crystal formation in the urine of patients with calcium oxalate stones: A randomized crossover clinical trial. [2023]Dietary supplementation with citrate-containing juices may serve as an effective alternative to potassium citrate therapy for preventing calcium oxalate stone recurrence. This study was performed to evaluate whether consumption of lemon-tomato juice can decrease the tendency for stone formation in the urine of calcium oxalate stone formers.
Chronopharmacological studies on potassium citrate treatment of oxalocalcic urolithiasis. [2019]The effect of minimum doses of extradietary potassium citrate ingestion on urolithogenic parameters has been studied. Separate urine fractions were collected in 24-hour periods. Five calcium oxalate stone formers have participated in the study. pH, calcium, citric acid, and the crystallization inhibitory capacity levels in fractional urine samples were determined before and during treatment. The most beneficial effect (increase in citraturia and crystallization inhibitory capacity) was produced by potassium citrate tablets ingested after dinner.
Alkali Citrate Content of Common Over-the-Counter and Medical Food Supplements. [2023]Objective: Potassium citrate effectively decreases kidney stone recurrence, but it is costly and associated with side effects. While several over-the-counter supplements and medical foods purport to provide sufficient citrate to prevent recurrent stones, corroborating data on their actual citrate content is limited. Materials and Methods: Nine common nonprescription products were purchased online. Reported citrate content was obtained from packaging, promotional materials, or ingredient labels. Using a single serving of each product, actual citrate, sodium, potassium, calcium, magnesium, and oxalate content was measured using spectrophotometry and chromatography. Total alkali citrate, cost, and amounts of each component per 10 mEq of alkali citrate were also calculated. Results: Nearly all products contained more citrate than advertised, except for Litholyte® powder, Litholyte® Coffee, and Horbäach® potassium citrate. Per serving, Moonstone® powder, LithoBalance™, and KSP tabs™ contained the most citrate (means of 63.9, 33.5, and 26.9 mEq, respectively). Moonstone and LithoBalance had the greatest discrepancy between total citrate and alkali citrate (15.7 and 11.8 mEq per serving, respectively). NOW® potassium citrate was least expensive ($0.04/10 mEq alkali citrate). KSP tabs delivered the most daily sodium (mean 158 mg/10 mEq alkali citrate, Litholyte Coffee provided the most potassium (mean of 13 mEq/10 mEq alkali citrate), and Kidney COP® provided the most calcium (mean 147 mg/10 mEq alkali citrate). Conclusion: Some common over-the-counter products contain sufficient alkali to potentially promote a citraturic response; Moonstone provides the most alkali citrate, but at a higher cost than other products. Sodium, potassium, and calcium from these products must also be considered in daily consumption.
[Therapeutic use of potassium citrate]. [2022]Therapeutic indications of potassium citrate include: 1. Oxaluric renal stone disease and some cases of uric acid stone disease. Prevention of stone formation in patients with renal polycystic disease. Prevention of stone relapse after ESWL or lithotomy; 2. Distal renal tubular acidosis complicated by hypercalciuria, mainly in children. 3. Renal hypercalciuria and hyperoxaluria. 4. Prevention of renal complications at the time of glaucoma treatment with acetazolamide. 5. Potassium supplementation during treatment of hypertension. Potassium citrate is usually contraindicated in the case of: 1. Urinary tract infection. 2. Struvite renal stone disease. 3. Hyperpotassemia and advanced chronic renal failure. 4. Peptic ulcer or gastritis. 5. Gastrointestinal bleeding. 6. Disorders of coagulation, crural varices. 7. Metabolic alkalosis. Potassium citrate, when used at therapeutic doses, is to be considered as quite safe. The average daily dose even if admitted as a single dose day engages 60-75% of free renal capacity for potassium excretion. Physiologic and therapeutic citrate concentration in urine exceeds much those available for other inhibitors. The therapeutic dose does not induce any significant changes in any biochemical or endocrine parameter of blood except mild transient metabolic alkalosis. The decrease of urine calcium and increase in oxalate calcium phosphate excretion is observed. In hypo-cytriaturic patients the response to therapeutic dose of citrate is smaller. One-year remission of stone disease is observed in 70-75% cases.
Potassium citrate vs. hydrochlorothiazide to reduce urinary calcium excretion in calcium oxalate stone patients with hypercalciuria: a prospective randomized study. [2022]Calcium oxalate (Ca-Ox) is the most common stone composition and one of the most common 24-h urine anomalies is hypercalciuria. The purpose of this study was to evaluate the efficacy of potassium citrate (K-CIT) for prevention of hypercalciuria in comparison with hydrochlorothiazide (HCT) in patients with calcium oxalate stones and hypercalciuria.