Impact of Sodium Bicarbonate on 24-hour Urine Parameters in Hypocitriuric and Uric Acid Stone Formers

NCT06335537 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: 2405
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The incidence of kidney stone disease continues to rise globally. Although the treatment of kidney stone disease has dramatically improved in recent years, surgical management remains invasive and expensive. Patients who develop kidney stones are at high risk of recurrence during their lifetime; therefore, prevention of stones should be a primary focus. 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 stones are the predominant stone composition in the United States, accounting for over 2/3rds of stones. Citrate is a key inhibitor of calcium oxalate crystal formation and thus increasing it in the urine of a calcium oxalate stone former is quite beneficial. Uric acid stones account for approximately 10 percent of all stone types. These stones form primarily due to an acidic urinary environment which is a prerequisite for crystal formation. Common medications for stone formers include potassium citrate which help to make the urine more alkaline. Although effective, these medications have side effects and may prove to be too expensive (upwards of $450/month). Consuming baking soda (sodium bicarbonate) may prove to be an inexpensive ($0.34/month) equally effective alternative with respect to increasing urinary citrate levels and alkalinizing the urine. Investigators hypothesize that twice a day oral baking soda in a liquid medium (e.g., water, orange juice, soda, etc.) can be an effective, and inexpensive alternative to urocit K with regard to alkalinizing the urine and raising urinary citrate levels.

Conditions

Uric Acid Stones

Keywords

uric acid; hypocitraturia

Outcome Measures

Primary Outcomes (2)

• Change in 24-hour Urinary pH

  The first primary outcome will be the change in urinary pH determined from the 24-hour urine analysis test conducted by Litholink®. Outcome variable: 24-hour urine pH greater than 6 (reference range from 5.8 to 6.2 pH).

  12 weeks

• Change in 24-hour Urinary Citrate

  The second primary outcome will be the change in urinary citrate determined from the 24-hour urine analysis test conducted by Litholink®. Outcome variable: 24-hour urine citrate greater than 450 milligrams per 24-hour (320 to 1,240 milligrams per 24-hour).

  12 weeks

Secondary Outcomes (2)

• Change in Supersaturation of Calcium Oxalate

  12 weeks

• Change in Supersaturation of Uric acid

  12 weeks

Study Arms (2)

Urocit-K, then Baking Soda

EXPERIMENTAL

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.

Drug: Potassium citrate; Drug: Sodium bicarbonate

Baking Soda, then Urocit-K

EXPERIMENTAL

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.

Drug: Potassium citrate; Drug: Sodium bicarbonate

Interventions

Potassium citrate DRUG

Urocit-K 30 mEQ orally taken in the morning and evening.

Also known as: Urocit-K

Baking Soda, then Urocit-K; Urocit-K, then Baking Soda

Sodium bicarbonate DRUG

Baking Soda dissolved in up to 250 mL of water ½ teaspoon (29.5 mEq) in the morning and ½ Teaspoon (29.5 mEq) in the evening.

Also known as: Baking Soda

Baking Soda, then Urocit-K; Urocit-K, then Baking Soda

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \> 18 years of age and \< 80 years of age,
• Hypocitriuric (\<320 mg/24 hours), Calcium Oxalate Stone or Uric Acid stone formers, currently on Urocit-K therapy as the standard of care.

You may not qualify if:

• Male or female \<18 years old or \> 80 years old.
• Currently taking thiazides or ACE inhibitor medications
• Pregnant women.
• Women who are breastfeeding or plan to breastfeed during study period
• History of abnormal renal function (defined as eGFR \<60 mL/min/1.73 m2), active urinary tract infection, diabetes, cystinuria, renal tubular acidosis, inflammatory bowel disease, chronic diarrhea, primary hyperparathyroidism, peptic ulcer disease.

Sponsors & Collaborators

• University of California, Irvine: lead

Study Sites (1)

University of California, Irvine Medical Center

Orange, California, 92868, United States

RECRUITING

Related Publications (7)

• Romero V, Akpinar H, Assimos DG. Kidney stones: a global picture of prevalence, incidence, and associated risk factors. Rev Urol. 2010 Spring;12(2-3):e86-96.

  PMID: 20811557 BACKGROUND

• Chen Z, Prosperi M, Bird VY. Prevalence of kidney stones in the USA: The National Health and Nutrition Evaluation Survey. Journal of Clinical Urology. 2019;12(4):296-302. doi:10.1177/2051415818813820

  BACKGROUND

• Rule AD, Lieske JC, Li X, Melton LJ 3rd, Krambeck AE, Bergstralh EJ. The ROKS nomogram for predicting a second symptomatic stone episode. J Am Soc Nephrol. 2014 Dec;25(12):2878-86. doi: 10.1681/ASN.2013091011. Epub 2014 Aug 7.

  PMID: 25104803 BACKGROUND

• Wiederkehr MR, Moe OW. Uric Acid Nephrolithiasis: A Systemic Metabolic Disorder. Clin Rev Bone Miner Metab. 2011 Dec;9(3-4):207-217. doi: 10.1007/s12018-011-9106-6.

  PMID: 25045326 BACKGROUND

• "Potassium Citrate Prices, Coupons & Savings Tips." GoodRx, www.goodrx.com/potassium-citrate.

  BACKGROUND

• Pinheiro VB, Baxmann AC, Tiselius HG, Heilberg IP. The effect of sodium bicarbonate upon urinary citrate excretion in calcium stone formers. Urology. 2013 Jul;82(1):33-7. doi: 10.1016/j.urology.2013.03.002. Epub 2013 Apr 18.

  PMID: 23602798 BACKGROUND

• ARM & HAMMER® Baking soda package. http://www.armandhammer.com/solutions/solution-53/Antacid.aspx.

  BACKGROUND

MeSH Terms

Interventions

Potassium Citrate; Sodium Bicarbonate

Intervention Hierarchy (Ancestors)

Citric Acid; Citrates; Tricarboxylic Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Bicarbonates; Carbonates; Carbonic Acid; Carbon Compounds, Inorganic; Inorganic Chemicals; Sodium Compounds

Study Officials

• Ralph V Clayman, MD

  University of California, Irvine

  STUDY DIRECTOR

• Sohrab N Ali, M.D

  University of California, Irvine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sohrab N Ali, M.D

CONTACT

7145062352; sohrabna@hs.uci.edu

Renai Yoon, B.S.

CONTACT

7144568176; yoonrh@hs.uci.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This is an unblinded study.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: The following study will be a randomized cross-over trial evaluating the effects of baking soda and Urocit-K on 24-hour urinary parameters in hypocitrituric calcium oxalate and uric acid stone formers. All participants that consent to participate in the study will undergo the same tests. Participants will begin a 2-week washout period of Urocit-K as their standard of care. After completion of the washout period subjects will be randomized to take either Urocit-K or Baking Soda for 4 weeks. After participants undergo a secondary 2-week washout period, then they are assigned to medication not taken in the first study period for 4 weeks.

Study Record Dates

• First Submitted: March 7, 2024
• First Posted: March 28, 2024
• Study Start: May 1, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: June 24, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)