Alkalinizing Agents for Kidney Stones

Overseen By Jessica Dai

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

15 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

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

What data supports the effectiveness of the treatment Crystal Lite, Litholyte, Potassium Bicarbonate, Potassium citrate, K-citrate, Sodium bicarbonate, Baking soda, Sodium hydrogen carbonate for kidney stones?

Research shows that potassium citrate is effective in managing kidney stones by increasing urine citrate levels, which helps prevent stone formation. Alternative alkalinizing agents like potassium bicarbonate and sodium bicarbonate may also be useful, though more studies are needed to confirm their effectiveness. ^{1 2 3 4 5}

Are alkalinizing agents like potassium citrate and sodium bicarbonate safe for humans?

Potassium citrate is generally safe and can help reduce kidney stone formation, but it may cause side effects for some people. Sodium bicarbonate is used as an alternative, but it may not be as effective in reducing certain types of kidney stones. ^{1 4 6 7 8}

How does the treatment for kidney stones using alkalinizing agents differ from other treatments?

This treatment is unique because it uses over-the-counter alkalinizing agents like potassium bicarbonate and sodium bicarbonate, which are more affordable and accessible compared to prescription potassium citrate. These agents help prevent kidney stones by making the urine less acidic, which is crucial for dissolving certain types of stones. ^{1 2 3 9 10}

What is the purpose of this trial?

The purpose of this study is to compare over the counter and alternative prescription urinary alkalinizing agents to slow release potassium citrate in their ability to modify urinary parameters associated with stone formation.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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 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]

References

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

The Impact of Alternative Alkalinizing Agents on 24-Hour Urine Parameters. [2022]

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

Alkalinizing Agents: A Review of Prescription, Over-the-Counter, and Medical Food Supplements. [2021]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Citrate and renal calculi. [2013]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Chronopharmacological studies on potassium citrate treatment of oxalocalcic urolithiasis. [2019]

5. Australia pubmed.ncbi.nlm.nih.gov

Potassium-sodium citrate prevents the development of renal microcalculi into symptomatic stones in calcium stone-forming patients. [2019]

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

Alkali action on the urinary crystallization of calcium salts: contrasting responses to sodium citrate and potassium citrate. [2019]

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

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

8. Iran pubmed.ncbi.nlm.nih.gov

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

9. India pubmed.ncbi.nlm.nih.gov

Oral dissolution therapy for renal radiolucent stones, outcome, and factors affecting response: A prospective study. [2022]

10. Italy pubmed.ncbi.nlm.nih.gov

Dissolution of radiolucent renal stones by oral alkalinization with potassium citrate/potassium bicarbonate. [2016]