Sodium Bicarbonate for Kidney Stones

Not yet recruiting at 5 trial locations
JB
Overseen ByJanelly B Jimenez
Age: 18+
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: University of California, Los Angeles
Must be taking: Potassium citrate
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether sodium bicarbonate, a more affordable alternative to potassium citrate, can prevent kidney stones by reducing urine acidity. The study compares the effects of sodium bicarbonate with potassium citrate to evaluate their effectiveness. Individuals who have had kidney stones and are using or considering potassium citrate might be suitable candidates. Participants will try both treatments briefly to determine which is more effective. As a Phase 1, Phase 2 trial, this research aims to understand how the treatment works in people and measure its effectiveness in an initial, smaller group.

Do I need to stop my current medications to join the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

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

Research has shown that sodium bicarbonate is generally safe for people with kidney stones. It reduces urine acidity, helping to prevent stone formation. Some studies suggest it can also increase citrate levels in urine, which is beneficial since low citrate can lead to more stones. Although detailed information on side effects is limited, sodium bicarbonate is usually safe for short-term use.

Potassium citrate, however, is a more established treatment for kidney stones. It can reduce the recurrence of stones by 75% in people with calcium-based stones. Most people tolerate potassium citrate well, though some may experience stomach upset.

Both treatments are under study to assess their effectiveness for people with kidney stones. For those considering joining a trial, it's important to know that sodium bicarbonate is being explored as a more affordable alternative to potassium citrate, which is already approved for use.12345

Why are researchers excited about this trial's treatments?

Most treatments for kidney stones, like potassium citrate, work by altering urine pH to prevent stone formation. But sodium bicarbonate, the study drug, offers a fresh approach by potentially being more effective at quickly neutralizing urine acidity. Researchers are excited because sodium bicarbonate could act faster, offering relief in days instead of weeks. Additionally, this treatment might be easier to tolerate for some patients, providing a more comfortable experience compared to standard options.

What evidence suggests that sodium bicarbonate might be an effective treatment for kidney stones?

Research suggests that baking soda (sodium bicarbonate) might help prevent kidney stones by reducing urine acidity, which can lower the risk of stone formation. Some studies have shown that it can also improve kidney function in individuals with long-term kidney issues. However, more research is needed to fully understand its effect on kidney stones. In this trial, participants will receive either sodium bicarbonate followed by potassium citrate or vice versa, with a washout period in between. Potassium citrate has proven effective, reducing the chance of new stones forming by up to 96%. In summary, while potassium citrate is known to work well, baking soda shows promise as a more affordable option.56789

Who Is on the Research Team?

KB

Kymora B Scotland, MD, PhD

Principal Investigator

University of California, Los Angeles

Are You a Good Fit for This Trial?

This trial is for adults over 18 with a history of kidney stones, specifically those who have low citrate levels in their urine and are currently using or considering potassium citrate for stone prevention.

Inclusion Criteria

I am over 18 years old.
I have had kidney stones in the past.
My urine test shows low citrate levels.
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 1 week of sodium bicarbonate followed by 1 week of potassium citrate after a washout period, or vice versa.

2 weeks
2 visits (in-person)

Follow-up

Participants are monitored for changes in urine pH, urinary ammonia excretion, and urinary citrate excretion.

2 weeks
1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Sodium Bicarbonate

Trial Overview

The study compares the effectiveness of sodium bicarbonate to prescription potassium citrate in alkalinizing urine among patients with kidney stones. It aims to determine if sodium bicarbonate can be a cheaper alternative.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Sodium Bicarbonate -> Potassium CitrateExperimental Treatment2 Interventions
Group II: Potassium Citrate -> Sodium BicarbonateExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of California, Los Angeles

Lead Sponsor

Trials
1,594
Recruited
10,430,000+

University of California, Davis

Collaborator

Trials
958
Recruited
4,816,000+

Brigham and Women's Hospital

Collaborator

Trials
1,694
Recruited
14,790,000+

Landspitali University Hospital

Collaborator

Trials
46
Recruited
467,000+

University of California, San Diego

Collaborator

Trials
1,215
Recruited
1,593,000+

Centre hospitalier de l'Université de Montréal (CHUM)

Collaborator

Trials
389
Recruited
143,000+

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/3897582/

Comparative efficacy of "specific" potassium citrate therapy ...

New stone formation was virtually eliminated by potassium citrate therapy (a decrease from 0.52 to 0.02 stones per patient per year, a remission rate of 96 per ...

Long-Term Treatment with Potassium Citrate and Renal ...

Results: Parallel to a significant rise in urinary citrate and decreased urinary calcium (all P < 0.001), KC led to a dramatic reduction in the stone event rate ...

Is potassium citrate effective for preventing kidney stone...

Potassium citrate and other potassium-containing citrate salts reduce kidney stone recurrence by 75% in patients with calcium-containing stones.

Successful management of uric acid nephrolithiasis with ...

Remission was experienced in 94.4% of patients, and the group stone formation rate declined by 99.2%. Detailed case reports were obtained in five patients ...

Real-World Effectiveness of Preventive Pharmacological ...

Data supporting the efficacy of preventive pharmacological therapy (PPT) to reduce urolithiasis recurrence are based on clinical trials.

Efficacy of potassium polycitrate on renal stone and ... - PMC

The use of potassium citrate in all children less than 2 years with renal stone or microlithiasis especially those with metabolic disorders, are recommended.

Potassium citrate (oral route) - Side effects & dosage

Potassium citrate is used to treat a kidney stone condition called renal tubular acidosis. It is also used to prevent kidney stones that may occur with gout.

Impact of potassium citrate on urinary risk profile, glucose and ...

Treatment with potassium citrate was associated with a significantly higher mean change in urinary citrate (P = 0.010) and urinary magnesium (P = 0.020)

Effect of Potassium Citrate on Calcium Phosphate Stones in a ...

Potassium citrate induces complex changes in urine chemistries and resultant supersaturation, which may not be beneficial in preventing calcium phosphate stone ...