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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assess how Crystal Light (a powdered drink mix), potassium citrate (a medication used to prevent kidney stones), or a combination of both affects risk factors for kidney stones in individuals with a history of kidney stones and specific urine conditions, such as low citrate levels or low pH (acidic urine). The study will test each treatment separately and in combination to determine their effectiveness in preventing stones. It seeks participants who have experienced kidney stones and have been diagnosed with low citrate levels or acidic urine. Participants must be willing to follow the study's guidelines and collect their urine for testing. As an unphased trial, this study offers a unique opportunity to contribute to research that could lead to new prevention methods for kidney stones.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that potassium citrate is safe for most people and is often used to treat and prevent kidney stones. While some individuals might experience mild nausea, serious side effects are rare. Potassium citrate lowers acid levels in urine, making stone formation more difficult.

Crystal Light is generally safe for occasional consumption. It increases urine output, reducing the chance of kidney stones. However, excessive intake of its sweeteners might cause stomach issues.

Combining potassium citrate with Crystal Light is believed to effectively prevent kidney stones. Studies have used this combination to assist those with stone problems. Together, they enhance protective effects without adding significant risks. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about using Potassium Citrate and Crystal Light for kidney stones because these treatments offer a potentially less invasive and more accessible approach than traditional options like surgery or prescription medications. Potassium Citrate works by altering the chemical composition of urine to reduce stone formation, while Crystal Light provides a simple, tasty way to increase fluid intake, which is crucial for preventing stones. By combining these two, there might be a synergistic effect, making it easier for patients to manage their condition at home without heavy reliance on more aggressive treatments.

What evidence suggests that this trial's treatments could be effective for kidney stones?

Research has shown that potassium citrate, a treatment in this trial, can prevent kidney stones by raising citrate levels in urine, which stops stones from forming. It is effective for various types of stones, including calcium oxalate, uric acid, and cystine stones. Crystal Light lemonade, another treatment option in this trial, can also help by increasing urine and citrate levels, reducing the risk of kidney stones. The citric acid in lemonade prevents calcium oxalate crystals from forming. This trial will also examine the combination of potassium citrate and Crystal Light, which may enhance effectiveness by boosting urine citrate and reducing calcium levels, further lowering the chance of stones. ^{2 6 7 8 9}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4525130/

Nutritional Management of Kidney Stones (Nephrolithiasis) This review article provides information about epidemiology, mechanism, diagnosis, and pathophysiology of kidney stone formation, and methods for the ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/30585747/

The Effect of Lemonade and Diet Lemonade Upon Urinary ... Results: Urine volume was significantly higher with both regular and diet lemonade consumption compared with baseline values. Urinary citrate significantly ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05389995?cond=Crystal%20structure&aggFilters=status:not%20rec%20ava&viewType=Table&rank=4

Potassium Citrate and Crystal Light Lemonade An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during a clinical study or within a certain amount of ...

4. researchgate.net researchgate.net/publication/5924775_Lemonade_Therapy_Increases_Urinary_Citrate_and_Urine_Volumes_in_Patients_with_Recurrent_Calcium_Oxalate_Stone_Formation

Lemonade Therapy Increases Urinary Citrate and Urine ... Citric acid can also increase urine output and reduce calcium oxalate crystal formation to decrease kidney stones [63] .

5. journals.sagepub.com journals.sagepub.com/doi/10.1177/23247096221114518

A Rocky Discontinuation of Diet Mountain Dew It found an increase in urinary citrate by 60 mg/day; however, this was not statistically significant (P = 0.34). Powdered mix drinks may ...

6. thekidneydietitian.org thekidneydietitian.org/best-drinks-for-kidney-stones/comment-page-1/

Top 6 Best Drinks For Kidney Stones No reason why any flavor of Crystal Light should be avoided for stones! ... Crystal Light Drink Mix, Lemonade, Lemonade – EWG's Food Scores

7. healthline.com healthline.com/nutrition/is-crystal-light-bad-for-you

Is Crystal Light Bad for You? For the average person, drinking it occasionally is unlikely to cause health problems. Crystal Light is a powder meant to be mixed into water to ...

8. urologyslo.com urologyslo.com/services/kidney-stones-prevention/

Kidney Stones Prevention The most important dietary factor to prevent kidney stones is hydration. People with kidney stones should drink 3-4 liters of water daily.

9. reddit.com reddit.com/r/HealthyFood/comments/xn4y04/any_negatives_about_drink_mixes_like_crystal_light/

Any negatives about drink mixes like Crystal light? Maltodextrin (one of the sweeteners) can cause GI issues at high levels. Ace k (another sweetener) may result in sugar cravings.