Potassium Citrate + Crystal Light for Kidney Stones

Overseen By Alyssa McDonald

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Northwestern University

Must not be taking: Carbonic anhydrase inhibitors

Disqualifiers: Severe hypocitraturia, Hyperkalemia, Uncontrolled diabetes, others

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

Compensation: Varies

Number of Visits: 1

Duration: 5 weeks

10 Participants Needed

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. ^{1 2 3 4 5}

Is 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. ^{1 2 3 4 6}

How 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. ^{1 2 6 7 8}

Eligibility 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 have completed a Litholink test with blood work results available.

Your urine pH level is less than 5.6.

Willing to follow experimental protocol

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.

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

Treatment Details

Interventions

• Crystal Light
• Potassium Citrate

Trial Overview 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.

Participant Groups

Group I: Potassium citrate Active Control 1 Intervention

Group II: Crystal light Active Control 1 Intervention

Group III: Crystal light + potassium citrate Active Control 1 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

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials

1,674

Recruited

989,000+

Findings from Research

Lemonade therapy (LT) alone significantly increased urinary citrate and total urine volume in patients with calcium oxalate stone formation, with a maximum increase of 203 mg/day in urinary citrate and 763 mL/day in urine volume.

When combined with potassium citrate, LT was even more effective, resulting in a greater increase in urinary citrate (346 mg/day) and total urine volume (860 mL/day), highlighting the potential for enhanced treatment strategies for preventing stone formation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lemonade therapy increases urinary citrate and urine volumes in patients with recurrent calcium oxalate stone formation. Penniston, KL., Steele, TH., Nakada, SY.[2013]

In a study of 176 children aged 5 to 18 with kidney stones, Polycitra-K was found to significantly reduce the occurrence of bladder stones compared to Bicitra, with 18.2% of Polycitra-K patients developing bladder stones versus 33% in the Bicitra group (p = 0.025).

Polycitra-K also led to a higher rate of stone passage, with 65.9% of patients in the Polycitra-K group successfully passing their stones compared to 40.9% in the Bicitra group, indicating its effectiveness in treating kidney stones through urine alkalization.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Polycitra-K and Bicitra in the Treatment of Pediatric Nephrolithiasis: A Double-Blind Randomized Trial. Razavi, MR., Vahedian, M., Motharinejad, F., et al.[2022]

In a study involving 126 children with lower ureteral stones, potassium citrate supplementation effectively increased urine pH and reduced sodium concentration, which are beneficial for preventing stone formation.

Both potassium citrate and lemonade supplementation did not significantly change urine volume, citrate levels, or uric acid levels, indicating that potassium citrate is a safe and effective option for managing pediatric urolithiasis without major side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Potassium Citrate is Better in Reducing Salt and Increasing Urine pH than Oral Intake of Lemonade: A Cross-Over Study. Shen, J., Zhang, X.[2019]

Adding Splenda to potassium citrate (KCit) significantly improved the taste of the supplement, making it more palatable for patients, with a taste score increase of 2.5 points (P=0.02).

The addition of Splenda did not change the beneficial effects of KCit on 24-hour urine parameters related to kidney stone risk, ensuring that the treatment remains effective while enhancing compliance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Splenda® improves tolerance of oral potassium citrate supplementation for prevention of stone formation: results of a randomized double-blind trial. Mechlin, C., Kalorin, C., Asplin, J., et al.[2016]

In a study of 70 asymptomatic urolithiasis patients, a combination of potassium citrate (K-Cit) and magnesium chloride (MgCl2) significantly reduced urinary stone size compared to K-Cit alone after 4 weeks of treatment.

The mean urinary stone size decreased from 5.1 ± 0.8 mm to 2.5 ± 1.2 mm in the group receiving the combination therapy, indicating that this combination may be a more effective treatment option for managing urinary stones.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating the effectiveness of adding magnesium chloride to conventional protocol of citrate alkali therapy on kidney stone size. Niroomand, H., Ziaee, A., Ziaee, K., et al.[2020]

Potassium citrate supplements can effectively reduce kidney stone recurrence by alkalinizing urine, but their citrate content and cost vary significantly, with Urocit-K and Thorne® showing the highest citrate levels per gram.

Among the supplements studied, NOW® and Nutricost® provided the most cost-effective options for alkali citrate, costing less than 1 cent per mEq, making them potentially more accessible alternatives for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmaceutical versus Over-the-Counter Potassium Citrate: A Benchtop Comparison. Wong, DG., Elson, L., Nottingham, CU., et al.[2023]

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]

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]

References

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

Lemonade therapy increases urinary citrate and urine volumes in patients with recurrent calcium oxalate stone formation. [2013]

2. Iran pubmed.ncbi.nlm.nih.gov

Effect of Polycitra-K and Bicitra in the Treatment of Pediatric Nephrolithiasis: A Double-Blind Randomized Trial. [2022]

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

Potassium Citrate is Better in Reducing Salt and Increasing Urine pH than Oral Intake of Lemonade: A Cross-Over Study. [2019]

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

Splenda® improves tolerance of oral potassium citrate supplementation for prevention of stone formation: results of a randomized double-blind trial. [2016]

5. India pubmed.ncbi.nlm.nih.gov

Evaluating the effectiveness of adding magnesium chloride to conventional protocol of citrate alkali therapy on kidney stone size. [2020]

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

Pharmaceutical versus Over-the-Counter Potassium Citrate: A Benchtop Comparison. [2023]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Citrate and renal calculi. [2013]

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

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