Potassium Citrate + Crystal Light 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: Northwestern University
Must not be taking: Carbonic anhydrase inhibitors
Disqualifiers: Severe hypocitraturia, Hyperkalemia, Uncontrolled diabetes, others
No Placebo Group
Trial Summary
What is the purpose of this trial?To define the effect of crystal light, potassium citrate, or both on urinary stone risk factors in patients with a history of stone and hypocitraturia/low pH
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, if you are taking medications that cause delayed gastric emptying or renal tubular acidosis, you may not be eligible to participate.
What data supports the effectiveness of the treatment Potassium Citrate + Crystal Light for kidney stones?
Research shows that potassium citrate can effectively prevent kidney stones by increasing urine pH and reducing sodium concentration, which helps dissolve certain types of stones. Additionally, lemonade therapy, which is similar to Crystal Light, can increase urinary citrate and urine volume, both of which are beneficial in preventing stone formation.
12345Is Potassium Citrate with Crystal Light safe for humans?
Potassium citrate is generally considered safe for humans and is used to prevent kidney stones by increasing urine pH and citrate levels. Studies have shown it to be effective with acceptable side effects, and it is often combined with drinks like Crystal Light to improve taste.
12346How does the treatment of Potassium Citrate + Crystal Light for kidney stones differ from other treatments?
The combination of Potassium Citrate and Crystal Light is unique because it not only increases urinary citrate levels, which helps prevent kidney stone formation, but also enhances urine volume, potentially offering a more comprehensive approach to managing kidney stones compared to using Potassium Citrate alone.
12678Eligibility Criteria
This trial is for men and women aged 18-80 with a history of kidney stones and low urine citrate or pH levels. Participants must be able to follow the study plan, collect their urine for testing, sign consent forms, have normal blood work results, and not have severe hypocitraturia or other specific health issues.Inclusion Criteria
I am between 18 and 80 years old.
I have completed a Litholink test with blood work results available.
Your urine pH level is less than 5.6.
+5 more
Exclusion Criteria
I have conditions like high potassium, uncontrolled diabetes, kidney disease, adrenal problems, slow stomach emptying, stomach ulcers, or a UTI.
I am part of a vulnerable patient group.
I am unable to make my own medical decisions.
+3 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive either crystal light, potassium citrate, or both to assess their effects on urinary stone risk factors
5 weeks
1 visit (in-person) at the end of week 5 for urine collection
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Participant Groups
The study aims to understand how potassium citrate alone, Crystal Light lemonade alone, or both combined affect factors in the urine that contribute to kidney stone formation in people who've had stones before and have low urinary citrate/pH.
3Treatment groups
Active Control
Group I: Potassium citrateActive Control1 Intervention
Group II: Crystal lightActive Control1 Intervention
Group III: Crystal light + potassium citrateActive Control1 Intervention
Crystal Light is already approved in United States, Canada for the following indications:
🇺🇸 Approved in United States as Crystal Light for:
- General hydration
- Flavor enhancement for water
🇨🇦 Approved in Canada as Crystal Light for:
- General hydration
- Flavor enhancement for water
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Northwestern UniversityChicago, IL
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Who Is Running the Clinical Trial?
Northwestern UniversityLead Sponsor
References
Lemonade therapy increases urinary citrate and urine volumes in patients with recurrent calcium oxalate stone formation. [2013]Potassium citrate is prescribed to patients with calcium oxalate (CaOx) stone formation to increase urinary citrate and pH, thus reducing CaOx crystal formation. Lemonade therapy (LT) might also increase urinary citrate and the total urine volume. We compared the effects of LT alone (group 1, n = 63) and potassium citrate plus LT (group 2, n = 37) in patients with CaOx stone formation on the urinary citrate and total urine volume to determine the efficacy of LT.
Effect of Polycitra-K and Bicitra in the Treatment of Pediatric Nephrolithiasis: A Double-Blind Randomized Trial. [2022]Background: Urolithiasis is a common, sever, painful, and costly disease with a high probability of relapse. This study was performed to compare the effect of Polycitra-K containing potassium citrate and Bicitra containing sodium citrate in the treatment of kidney stones in children who referred to Hazrat Masoumeh hospital in Qom. Methods: This double-blind randomized clinical trial study was carried out on 176 patients aged between 5 and 18 years old with kidney stones, hypocitraturia, and negative urine who referred to Hazrat Masoumeh hospital in Qom (Iran). Patients were divided into 2 groups of treatment (a dose of 1 mL/kg or 1-1.5 mg/ kg Polycitra-K) and control (Bicitra in the same dose). The results of kidney ureter bladder X ray (KUB ) was followed and the 2 groups were compared. The chi-square test or the Fisher exact test was used to analyze qualitative values in the treated groups. Results: Regarding bladder stones, there was a significant difference between the 2 treatment groups (p = 0.025), in which16 patients (18.2%) in the Polycitrat-K group and 29 patients (33%) in the Bicitra group had bladder stones. With respect to stone passage, 58 patients (65.9%) in the Polycitra-K group and 36 patients (40.9%) in the Bicitra group were recorded. Conclusion: Oral Polycitrat-K is an effective preferential supplement against kidney stones in children due to urine alkalization, but the results of our study showed that both Polycitrat-K and Bicitra drugs have similar effects as therapeutic agents. Registration code in the Iranian Registry of Clinical Trials: IRCT20190619043945N1.
Potassium Citrate is Better in Reducing Salt and Increasing Urine pH than Oral Intake of Lemonade: A Cross-Over Study. [2019]BACKGROUND Urine solute supersaturation leads to the formation of urinary tract caliceal stones. Many parameters can be involved in the supersaturation of solutes in urine, such as pH. Uric acid has pKa ≤5.5, and it is solubilized at pH ≥5.5. The objective of the study was to evaluate the effects of potassium citrate and lemonade supplementation in pediatric patients with urolithiasis. MATERIAL AND METHODS A total of 126 children who had lower ureteral stones calculi and fragments with severe colic pain participated in this cross-over study. Children drank lemonade (2 mEq/kg/day citrate) in 3 divided doses for 5 days. After a 15-day washout period, children drank 2 mEq/kg/day of potassium citrate in 3 divided doses for 5 days. On the sixth of the day of individual intervention, a 24-h urine sample was collected and evaluated for pH, urine volume, citrate level, uric acid level, magnesium, phosphorus, potassium, and sodium. Urinary parameters for 1-day urine collection measurements after each supplementation were compared with baseline using the Mann-Whitney test following Tukey post hoc test at 95% confidence level. RESULTS Potassium citrate supplementation resulted in reduction of sodium concentration (p=0.0337; q=3.76) and increased pH of urine (p=0.0118; q=4.389). However, urine volume, citrate level, and uric acid level, as well as elemental magnesium, phosphorus, and potassium, remained unchanged after 5 days of supplementation with potassium citrate or lemonade. CONCLUSIONS Potassium citrate supplementation is an effective therapy for preventing pediatric urolithiasis, with acceptable adverse effects.
Splenda® improves tolerance of oral potassium citrate supplementation for prevention of stone formation: results of a randomized double-blind trial. [2016]Oral citrate supplements have been shown to decrease kidney stone recurrence rates in both laboratory and clinical studies. The taste of the citrate supplements, however, is poor, and long-term compliance is low. Our objective was to determine if Splenda(®) added to potassium citrate (KCit) improves palatability without changing 24-hour urine parameters.
Evaluating the effectiveness of adding magnesium chloride to conventional protocol of citrate alkali therapy on kidney stone size. [2020]Label="BACKGROUND" NlmCategory="BACKGROUND">Potassium citrate (K-Cit) is one of the therapeutic solutions broadly used in patients with urolithiasis. However, recent studies have shown that it is not so effective. Therefore, the goal of our study was to evaluate the effect of a combination of K-Cit - MgCl2 oral supplements, on urinary stone size.
Pharmaceutical versus Over-the-Counter Potassium Citrate: A Benchtop Comparison. [2023]Potassium citrate has been shown to significantly reduce kidney stone recurrence by alkalinizing urine and increasing citrate excretion. However, the cost of potassium citrate can be prohibitive. Thus, over-the-counter use of potassium citrate supplements has gained interest from patients and providers due to reported decreased cost. Prior studies show that fluids such as orange juice, Crystal Light and certain sodas are reasonable sources of alkali citrate; however, the true alkali citrate content among leading over-the-counter supplements is unknown. We investigate popular supplements and compare them to pharmaceutical potassium citrate.
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.
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.