Sodium Bicarbonate for Kidney Stones

Overseen By Sohrab N Ali, M.D

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: University of California, Irvine

Must be taking: Urocit-K

Must not be taking: Thiazides, ACE inhibitors

Disqualifiers: Pregnancy, Diabetes, Renal dysfunction, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether baking soda (sodium bicarbonate) can prevent kidney stones by reducing urine acidity and increasing citrate, a key substance that prevents stone formation. Researchers aim to determine if this affordable option is as effective as the commonly used medication, Urocit-K, but with fewer side effects and lower cost. Participants will alternate between taking Urocit-K and baking soda to compare the effects. Individuals dealing with calcium oxalate or uric acid kidney stones and currently using Urocit-K might be suitable for this trial. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants a chance to contribute to groundbreaking research.

Will I have to stop taking my current medications?

The trial requires participants to be currently on Urocit-K therapy, so you will not need to stop this medication. However, if you are taking thiazides or ACE inhibitors, you cannot participate in the trial.

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

Research shows that sodium bicarbonate, or baking soda, often makes urine less acidic and helps slow kidney disease, including conditions like kidney stones. Studies have found that it can increase urinary citrate levels, potentially preventing kidney stones from forming.

Sodium bicarbonate is generally well-tolerated, especially in common doses, and many people already consume it in small amounts. No major side effects have been reported for this purpose. However, consulting a doctor before starting any new treatment is always important.

In this trial, researchers compare sodium bicarbonate to another treatment called Urocit-K. Both aim to prevent kidney stones. Sodium bicarbonate is a more affordable option, which could be appealing. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for kidney stones?

Researchers are excited about using sodium bicarbonate for kidney stones because it offers a potentially simple and cost-effective alternative to current treatments like potassium citrate (Urocit-K). Sodium bicarbonate, commonly known as baking soda, might help prevent kidney stones by altering urine pH and reducing stone-forming compounds. Unlike other treatments that might require prescriptions, baking soda is widely available and easy to use, which could make it accessible for more people. This approach could provide an effective way to manage kidney stones with fewer side effects and lower costs.

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

This trial will compare the effectiveness of sodium bicarbonate (baking soda) with Urocit-K in preventing kidney stones. Studies have shown that sodium bicarbonate can prevent kidney stones by increasing citrate levels in the urine, which helps stop the formation of calcium oxalate crystals, a common type of kidney stone. Research also indicates that baking soda can reduce urine acidity, crucial for preventing uric acid stones. Some studies have found sodium bicarbonate to be as effective as treatments like potassium citrate, but at a lower cost. Additionally, previous patients demonstrated improved kidney function when using sodium bicarbonate. Overall, these findings suggest that sodium bicarbonate could be a promising and affordable option for preventing kidney stones. ^{1 2 4 6 7}

Who Is on the Research Team?

Ralph V Clayman, MD

Principal Investigator

University of California, Irvine

Sohrab N Ali, M.D

Principal Investigator

University of California, Irvine

Are You a Good Fit for This Trial?

This trial is for individuals with kidney stones, specifically those who form stones due to low citrate levels or acidic urine. It's not specified who can't join the trial, but typically participants would need to be in stable health and not have conditions that could interfere with the study.

Inclusion Criteria

I have low urine citrate levels and take Urocit-K for my kidney stones.

Exclusion Criteria

Women who are breastfeeding or plan to breastfeed during study period

I am currently on thiazides or ACE inhibitors.

I have kidney problems, UTI, diabetes, or other listed conditions.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

Treatment - Urocit-K

Participants take Urocit-K 30 mEq AM and 30 mEq PM for four weeks, with urine collections and blood tests

4 weeks

2 visits (in-person) for urine collection and blood tests

Washout

Participants undergo a washout period after Urocit-K treatment

2 weeks

Treatment - Baking Soda

Participants take Baking Soda dissolved in water, ½ teaspoon AM and PM for four weeks, with urine collections and blood tests

4 weeks

2 visits (in-person) for urine collection and blood tests

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Sodium Bicarbonate

Trial Overview The study tests if baking soda (sodium bicarbonate) taken twice a day is as effective as potassium citrate at increasing urinary citrate levels and making urine less acidic, which may prevent kidney stone formation.

How Is the Trial Designed?

Group I: Urocit-K, then Baking Soda Experimental Treatment 2 Interventions

After being off Urocit-K for two weeks, participants will collect two 24-hour urine tests to document hypocitraturia or low urine pH for calcium oxalate or uric acid stone formers, respectively. Participants will take Urocit-K 30 mEq AM and 30 mEq PM for four-weeks. During the last two days of the four-week drug period, two 24-hour urine collections will be obtained, and the participants will enter another washout period of two weeks before switching over to Baking Soda dissolved in up to 250 mL of water ½ teaspoon (29.5 mEq) in AM and ½ Teaspoon (29.5 mEq) in PM for four weeks. During the last two days of this study arm, two 24-hour urine collections will be obtained. A basic metabolic panel blood test will be obtained at the end of the study arm.

Group II: Baking Soda, then Urocit-K Experimental Treatment 2 Interventions

After being off Urocit-K for two weeks, participants will collect two 24-hour urine tests to document hypocitraturia or low urine pH for calcium oxalate or uric acid stone formers, respectively. Participants will take Baking Soda dissolved in up to 250 mL of water ½ teaspoon (29.5 mEq) in AM and ½ Teaspoon (29.5 mEq) in PM for four weeks. During the last two days of the four-week drug period, two 24-hour urine collections will be obtained, and the participants will enter another washout period of two weeks before switching over to Urocit-K 30 mEq AM and 30 mEq PM for four weeks. During the last two days of this study arm, two 24-hour urine collections will be obtained. A basic metabolic panel blood test will be obtained at the end of the study arm.

Sodium Bicarbonate is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Sodium Bicarbonate for:

• Metabolic acidosis
• Heartburn
• Acid indigestion
• Upset stomach
• Severe renal disease
• Circulatory insufficiency due to shock

Approved in European Union as Sodium Bicarbonate for:

• Metabolic acidosis
• Heartburn
• Acid indigestion
• Upset stomach
• Severe renal disease
• Circulatory insufficiency due to shock

Approved in Canada as Sodium Bicarbonate for:

• Metabolic acidosis
• Heartburn
• Acid indigestion
• Upset stomach
• Severe renal disease
• Circulatory insufficiency due to shock

Who Is Running the Clinical Trial?

University of California, Irvine

Lead Sponsor

Trials

580

Recruited

4,943,000+

Published Research Related to This Trial

In a study of 16 well-nourished patients on maintenance hemodialysis, sevelamer hydrochloride was found to significantly lower serum bicarbonate levels compared to calcium carbonate, indicating a potential worsening of metabolic acidosis during sevelamer treatment.

While both sevelamer and calcium carbonate effectively controlled serum phosphate levels, calcium carbonate maintained serum bicarbonate concentrations within target levels, highlighting its advantage in managing metabolic acidosis in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sevelamer worsens metabolic acidosis in hemodialysis patients. De Santo, NG., Frangiosa, A., Anastasio, P., et al.[2015]

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]

A proposed study will involve 600 patients with chronic kidney disease (CKD) stages 3b and 4 to assess whether sodium bicarbonate can effectively reduce renal death and cardiovascular mortality by correcting metabolic acidosis.

The study aims to compare outcomes between a bicarbonate treatment group and a usual-treatment group, providing crucial data on the potential benefits and risks of alkalinizing agents in pre-end-stage renal disease patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A prospective, multicenter, randomized, controlled study: the correction of metabolic acidosis with use of bicarbonate in Chronic Renal Insufficiency (UBI) Study. Di Iorio, B., Aucella, F., Conte, G., et al.[2013]

In a study involving 34 healthy volunteers, potassium sodium hydrogen citrate (PSHC) was found to significantly increase urine pH levels compared to sodium bicarbonate (NaHCO3), indicating that PSHC is more effective for urinary alkalization.

The study also revealed a natural circadian rhythm in urine pH, with both PSHC and NaHCO3 elevating urine pH levels without disrupting this rhythm, suggesting that PSHC can be used effectively without adverse effects on the body's natural processes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison potassium sodium hydrogen citrate with sodium bicarbonate in urine alkalization: a prospective crossover-controlled trial. Xue, W., Cheng, J., Zhao, J., et al.[2023]

In a study of 114 patients with chronic kidney disease (CKD) or end-stage renal disease (ESRD), a single 30g dose of sodium polystyrene sulfonate (SPS) significantly reduced serum potassium levels by a median of 0.8 mEq/L within 24 hours, indicating its efficacy in treating hyperkalemia.

While SPS was effective in lowering potassium, gastrointestinal side effects were reported in 5% of patients, raising concerns about potential risks associated with its use in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Single-dose sodium polystyrene sulfonate for hyperkalemia in chronic kidney disease or end-stage renal disease. Hunt, TV., DeMott, JM., Ackerbauer, KA., et al.[2023]

Sodium bicarbonate products, including bicaNorm and Nephrotrans, are of sufficient pharmaceutical quality, but they release the drug differently at various pH levels, which can lead to potential dose dumping and adverse effects due to carbon dioxide production.

The soft capsule formulation (Nephrotrans) demonstrated the least sodium bicarbonate release at low pH, suggesting it may be a safer and more effective option compared to enteric-coated tablets and pellet formulations, aligning with reports of adverse effects in patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enteric-coated solid dosage forms containing sodium bicarbonate as a drug substance: an exception from the rule? Breitkreutz, J., Gan, TG., Schneider, B., et al.[2014]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12210412/

Dietary baking soda (NaHCO3) therapy recovered ... The results demonstrated that NaHCO3 effectively reduced the deposition of CaOx crystal, as well as restored kidney function in urolithiasis- ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10310507/

Association of serum bicarbonate with the development ... Epidemiological studies demonstrate an association between kidney stones and risk of chronic kidney disease (CKD) and CKD progression.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06335537

Impact of Sodium Bicarbonate on 24-hour Urine ... Consuming baking soda (sodium bicarbonate) may prove to be an inexpensive ($0.34/month) equally effective alternative with respect to increasing urinary ...

4. ucihealth.org ucihealth.org/clinical-trials/ccr-24-77

Impact of Sodium Bicarbonate on 24-hour Urine... The use of baking soda in stone formers with calcium oxalate associated hypocitraturia or with uric acid stones will increase urinary citrate and increase ...

5. renalandurologynews.com renalandurologynews.com/news/sodium-bicarbonate-effects-on-calcium-phosphate-citrate-nephrolithiasis/

Sodium Bicarbonate May Mitigate Calcium Phosphate ... Compared with placebo, the higher-dose and lower-dose sodium bicarbonate groups experienced a significant mean 0.97 and 0.77 increase in urinary ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06335537

Impact of Sodium Bicarbonate on 24-hour Urine ... Low levels of citrate and acidic urine are risk factors for the formation of kidney stones such as calcium oxalate and uric acid, respectively. Calcium oxalate ...

7. kidney.org kidney.org/kidney-failure-risk-factor-serum-bicarbonate

Kidney Failure Risk Factor: Serum Bicarbonate The normal level of serum bicarbonate is 22-29 mEq/L. Kidney experts recommend that patients not have their serum bicarbonate levels fall below 22 mEq/L.