Chlorthalidone + Low Oxalate Diet for Kidney Stones
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores new methods to prevent kidney stones, specifically calcium oxalate stones, by testing a combination of chlorthalidone (a type of diuretic) and a low oxalate diet. Researchers aim to determine if a simpler approach, without detailed urine analysis, can be as effective as a more customized treatment plan. It is ideal for individuals diagnosed with calcium oxalate kidney stones who are scheduled for a procedure called percutaneous nephrolithotomy (PCNL). As a Phase 4 trial, this study involves an FDA-approved treatment and seeks to understand how it benefits a broader range of patients.
Do I need to stop my current medications for the trial?
Yes, if you are currently on thiazides, loop diuretics, or certain other medications like glucocorticoids or potassium supplements, you will need to stop them to participate in the trial.
What is the safety track record for these treatments?
Research has shown that chlorthalidone is a well-tolerated option for preventing kidney stones. Studies indicate it can lower the chance of recurrence and effectively prevent stones. Some studies specifically mention that taking chlorthalidone at doses of 25 or 50 mg daily can successfully reduce the recurrence of kidney stones.
Patients might experience side effects like dizziness or changes in electrolyte levels, but these are usually manageable. Importantly, chlorthalidone is already approved for treating other conditions, like high blood pressure, which adds reassurance about its safety.
Regarding the low oxalate diet, research suggests it can help reduce the formation of kidney stones. This diet involves eating fewer foods high in oxalates, compounds that can lead to stones. It has been effective in reducing stone recurrence for many patients without causing significant side effects.
Overall, both treatments have shown safety with minimal side effects for most patients.12345Why are researchers enthusiastic about this study treatment?
Most treatments for kidney stones involve pain management and waiting for stones to pass naturally, or in some cases, surgical removal. However, researchers are excited about the combination of chlorthalidone and a low oxalate diet because it offers a proactive approach. Chlorthalidone is a diuretic that reduces calcium levels in urine, potentially decreasing stone formation, while the low oxalate diet targets one of the primary components of these stones. This dual approach not only targets the cause but may also prevent the recurrence of stones, offering a preventative strategy that current treatments do not typically address.
What evidence suggests that this trial's treatments could be effective for kidney stones?
Studies have shown that chlorthalidone, a long-lasting water pill, effectively prevents calcium kidney stones. It helps the kidneys eliminate more salt and water, reducing the likelihood of stone formation. Research also indicates that a low-oxalate diet, which decreases oxalate in the urine, can lower the risk of kidney stones. Patients on this diet have experienced fewer recurrences of kidney stones. In this trial, participants in the empiric therapy arm may receive chlorthalidone, a low-oxalate diet, or both, depending on their stone composition. The selective therapy arm will tailor treatment based on specific urine analysis results, offering a comprehensive approach to prevention.13567
Who Is on the Research Team?
Mantu Gupta, MD
Principal Investigator
Mount Sinai West
Are You a Good Fit for This Trial?
This trial is for patients with calcium oxalate kidney stones who are undergoing a specific surgical procedure called percutaneous nephrolithotomy. It's not clear what the exclusion criteria are, but typically participants would need to meet certain health standards and be able to follow the study protocol.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either empiric therapy or selective therapy based on 24-hour urine evaluation
Follow-up
Participants are monitored for changes in calcium oxalate supersaturation and other urinary markers
What Are the Treatments Tested in This Trial?
Interventions
- Chlorthalidone
- Low oxalate diet
Trial Overview
The study at Mount Sinai West is testing two approaches to prevent kidney stones from coming back: one group will get a water pill called Chlorthalidone and follow a low oxalate diet without further tests, while another group's treatment will be based on their urine test results.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Patients randomized to the empiric group will receive treatment based on the pH on urinalysis and stone composition. Patients with greater than 50% calcium oxalate monohydrate (COM) stone composition will be counseled on a low oxalate diet by a medical provider. Patients with greater than 50% calcium oxalate dihydrate (COD) stone composition will be prescribed 25 mg of chlorthalidone once a day. In the rare event the stone composition is 50% COM and 50% COD, then those patients will receive both low oxalate diet counseling and a prescription for chlorthalidone.
Patients randomized to the selective group will undergo medical therapy based on the American Urological Association (AUA) guidelines from the 24-hour urine collection results. Patients with idiopathic hyperoxaluria (\> 40mg/day) will receive a low oxalate diet and receive the same dietary counseling, handout, and questionnaire as the empiric group. Patients with idiopathic hypercalciuria (\> 250mg in men, \>200mg in women) will be prescribed 25mg of chlorthalidone once a day.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Icahn School of Medicine at Mount Sinai
Lead Sponsor
Citations
Indapamide or chlorthalidone to reduce urine supersaturation ...
The purpose of this study is to assess if indapamide or chlorthalidone is a promising candidate compound for reducing the risk of kidney stone ...
2.
healio.com
healio.com/news/nephrology/20250411/longacting-diuretic-chlorthalidone-may-increase-kidney-stone-riskLong-acting diuretic chlorthalidone may increase kidney ...
The main outcome was the occurrence of kidney stones, tracked over a mean 4.2 years. Researchers found no substantial differences in new kidney ...
Effect of Chlorthalidone and Hydrochlorothiazide on 12- ...
We conclude that CTD is a longer acting and more effective agent for prevention of calcium kidney stones, although varying dose timing for a ...
4.
medscape.com
medscape.com/viewarticle/chlorthalidone-increases-kidney-stone-recurrence-2025a10008qnChlorthalidone Increases Kidney Stone Recurrence
With an average follow-up of 4.2 years, no significant differences were observed between the two groups in the development of new kidney stone ...
Indapamide or chlorthalidone to reduce urine ...
The study targets enrolment of 99 participants to achieve 80% power for detecting a 20% reduction in the relative supersaturation ratios of ...
Chlorthalidone with potassium citrate decreases calcium ...
Chlorthalidone with potassium citrate decreases calcium oxalate stones and increases bone quality in genetic hypercalciuric stone-forming rats - PMC.
7.
journals.lww.com
journals.lww.com/co-nephrolhypertens/fulltext/2024/07000/thiazides_for_kidney_stone_recurrence_prevention.11.aspxThiazides for kidney stone recurrence prevention
Both indapamide (at a dose of 2.5 mg daily) and chlorthalidone (at doses of 25 or 50 mg daily) reduced kidney stone recurrence in one past RCT each [14,15]. ...
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