Alkalinizing Agents for Kidney Stones

Overseen By Ashley Gonzalez, MD

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: University of Texas Southwestern Medical Center

Disqualifiers: Pregnancy, Nursing, Metabolic diet, others

Compensation: Varies

Number of Visits: Unknown

Duration: 8 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests different treatments to determine their effectiveness in altering urine chemistry to prevent kidney stones. It compares over-the-counter and prescription options, such as Crystal Lite, Litholyte, and potassium or sodium bicarbonate, against slow-release potassium citrate, an alkalinizing agent. Individuals who have or haven't had kidney stones but can adhere to a special diet might be suitable candidates. The goal is to identify the most effective method for reducing the risk of kidney stone formation. As an Early Phase 1 trial, this research aims to understand how these treatments work in people, offering participants a chance to contribute to innovative kidney stone prevention strategies.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

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

Research shows that the treatments under study have been used before, and most have a good safety record. Potassium citrate is often given to prevent kidney stones and is usually well-tolerated, though some people might experience nausea. Sodium bicarbonate, also known as baking soda, is used to make urine less acidic and is considered safe and affordable. However, monitoring intake is important because high levels can affect kidney function.

Potassium bicarbonate, like potassium citrate, helps manage urine acidity and has been used widely without major safety issues. Crystal Lite, a lemon-flavored drink, may help lower the risk of kidney stones because it contains citrate, but monitoring potassium levels is important, especially for those with kidney disease.

Litholyte, an over-the-counter supplement, is similar to potassium citrate and generally shares its safety profile. It balances minerals in the kidneys and usually has minimal side effects. Overall, these treatments have been used safely in various situations, but individual reactions can vary, so healthcare provider monitoring is important. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the treatments being studied for kidney stones because they offer different approaches to alkalinizing urine, which can prevent stone formation. Unlike standard treatments like thiazide diuretics and allopurinol, which focus on reducing calcium or uric acid in the urine, these treatments use alkalinizing agents such as potassium bicarbonate, potassium citrate, and sodium bicarbonate to increase urine pH, making it less likely for stones to form. Additionally, some treatments like Crystal Lite and Litholyte offer more user-friendly options, potentially improving adherence due to their palatability and ease of use. With these unique features, these treatments may provide more effective and patient-friendly alternatives for managing kidney stones.

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

This trial will compare several alkalinizing agents for kidney stones. Research has shown that potassium citrate, one of the treatments in this trial, effectively treats kidney stones by increasing citrate levels in urine and reducing stone formation by up to 96%. Potassium bicarbonate, another treatment option, shows promise, with some patients experiencing a 99.2% reduction in stone formation. Sodium bicarbonate, also tested in this trial, helps by reducing calcium oxalate crystals, a common type of kidney stone. Litholyte, another treatment arm, may increase urine pH and citrate levels, but results have not yet reached statistical significance. Crystal Lite, also part of this trial, contains some citrate but has only shown minor, non-significant changes in urine. These treatments work by making the urine less acidic, which can help prevent stones. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adults aged 18 or older, with or without a history of kidney stones. It's not suitable for those who can't take the medications due to health reasons, pregnant or nursing individuals, anyone unable to follow a strict metabolic diet, or if they've had bad reactions to these meds before.

Inclusion Criteria

I may or may not have had kidney stones before.

Exclusion Criteria

Participants who are pregnant or nursing

I cannot take certain medications due to health reasons.

You cannot follow the special diet required for the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive various alkalinizing agents to compare their effects on urinary stone risk parameters

8 days

Daily monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

10 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Crystal Lite
• Litholyte
• Potassium Bicarbonate
• Potassium citrate
• Sodium bicarbonate

Trial Overview

The study compares different urinary alkalinizing agents like Potassium Bicarbonate, Litholyte, Crystal Lite, Sodium bicarbonate and prescription Potassium citrate. Their effectiveness in changing urine properties to reduce kidney stone risk while on a controlled diet is being tested.

How Is the Trial Designed?

Group I: Crystal Lite Active Control 5 Interventions

Group II: Potassium Bicarbonate Active Control 5 Interventions

Group III: Potassium citrate Active Control 5 Interventions

Group IV: Sodium Bicarbonate Active Control 5 Interventions

Group V: Litholyte arm Active Control 5 Interventions

Group VI: Metabolic diet Placebo Group 5 Interventions

Controlled metabolic diet arm.

Who Is Running the Clinical Trial?

University of Texas Southwestern Medical Center

Lead Sponsor

Trials

1,102

Recruited

1,077,000+

Published Research Related to This Trial

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]

In a study involving five calcium oxalate stone formers, the ingestion of minimum doses of potassium citrate significantly increased citraturia and crystallization inhibitory capacity in urine samples.

The most effective timing for taking potassium citrate was after dinner, suggesting that this method could help reduce the risk of kidney stone formation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chronopharmacological studies on potassium citrate treatment of oxalocalcic urolithiasis. Grases, F., Conte, A., March, JG., 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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Citrate and renal calculi. Pak, CY.[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]

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.

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 ...

LT resulted in favorable changes in urinary citrate and total urine volume in our series. Potassium citrate with LT was more effective than LT ...

3.

sciencedirect.com

sciencedirect.com/science/article/pii/S1607551X13000247

Effects of commercial citrate-containing juices on ...

Our results showed that apple, cranberry, orange, and pomegranate juices failed to reduce calcium oxalate (CaOx) crystal formation.

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9410446/

Diet and Stone Disease in 2022 - PMC - PubMed Central

Non-significant increase in urinary pH (by 0.25, p > 0.05), citrate (by 155 mg/day, p ≥ 0.05), and volume (by 200 cc/day, p > 0.05) in Crystal Lite® group.

5.

liebertpub.com

liebertpub.com/doi/10.1089/end.2018.0623

The Effect of Lemonade and Diet Lemonade Upon Urinary ...

Lemon-flavored Crystal Light® is another low-calorie beverage that may lower the risk of kidney stone formation as its citrate concentration appears to be ...

6.

journals.sagepub.com

journals.sagepub.com/doi/10.1177/23247096221114518

A Rocky Discontinuation of Diet Mountain Dew

It was theorized that the high citrate in Diet Mountain Dew was protective against his newly recurrent nephrolithiasis. For lifestyle preference ...

7.

connect.mayoclinic.org

connect.mayoclinic.org/discussion/kidney-stones-and-drinking-80-to-100-ounces-daily/

Kidney stones and drinking 80 to 100 ounces daily.

If you have kidney disease, be sure to look at the label of the Crystal light. You want to be sure you are not getting too much potassium, ...

8.

sciencedirect.com

sciencedirect.com/science/article/pii/S0085253815504924

Crystal-associated nephropathy in patients with brushite ...

We believe crystallization obstructs and destroys terminal collecting duct segments thereby damaging nephrons, perhaps via intranephronal obstruction.