Ignite Creation Date:
2024-05-06 @ 8:19 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06335537
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-24
First Post:
2024-03-07
Brief Title:
Impact of Sodium Bicarbonate on 24-hour Urine Parameters in Hypocitriuric and Uric Acid Stone Formers
Sponsor:
University of California Irvine
Organization:
University of California Irvine
Study Overview
Official Title:
Impact of Sodium Bicarbonate on 24-hour Urine Parameters in Hypocitriuric and Uric Acid Stone Formers
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 23rds 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 450month Consuming baking soda sodium bicarbonate may prove to be an inexpensive 034month 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 eg 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
Detailed Description:
The incidence and prevalence of kidney stone disease has continually increased in both developed and underdeveloped countries With the surge in cases the cost of treatment has also increased substantially In 2014 it has been reported that treatment of kidney stones cost a total of 281 billion USD and this is projected to increase by 124 billion USD per year Although there has been great technological advancement in surgical treatment of kidney stones such as minimally invasive surgery the rate of recurrence is unfortunately high among stone formers upwards of 50 percent at 5-10 years Recurring stone disease results in more frequent surgical interventions and further expense Thus there is an increasing need for primary stone prevention
Kidney stones have varying compositions with the most common being calcium oxalate Uric acid stones are the third most common type of stone and account for 10 percent of all stone formers One of the common abnormalities for patients with calcium oxalate stones is low citrate levels in the urine Citrate is the primary inhibitor of calcium oxalate crystal formation growth and aggregation As such regimens to increase urinary citrate have been undertaken The most common drug used in this regard is potassium citrate ie Urocit K While effective the drug remains costly with prescription costs ranging as high as 450month With regard to uric acid stone formation a prerequisite is an acidic urine given that the pKa for uric acid is a pH of 55 once the pH is above 60 uric acid stones do not form Indeed the uric acid stone is the only one that can be dissolved if one is able to raise the pH to 65 -70
Current medical therapy for hypocitraturia in patients with calcium oxalate stones is the use of a slow-release tablet of potassium citrate eg UrocitK Current medical therapy for uric acid stone formers is likewise potassium citrate as it will raise the urine pH A prescription of potassium citrate with the typical dosage of 30 meq twice a day can cost the patient upwards of 450month Additionally potassium citrate tablets are associated with adverse effects such as nausea and diarrhea with additional concerns with respect to the potassium load among patients with poor renal function Furthermore the wax matrix tablets are large in size and difficult to swallow
Pinheiro et al in a prior study demonstrated that sodium bicarbonate in tablet form at a dose of 60 milliequivalent mEq per day was comparable to Urocit-K in increasing urinary pH and urinary citrate levels in calcium stone forming hypocitriuric patients The study was limited by a small sample size n16 and short duration of therapy 3 days Despite these favorable results over the ensuing decade there has been minimal interest in the use of sodium bicarbonate as a preventative treatment in stone formers who are hypocitriuric or uric acid stone formers
Baking soda is a common household item and is openly available throughout the world in most grocery stores The main component of baking soda is sodium bicarbonate Various studies have shown that a teaspoon of baking soda 48g has an equivalent of 59 mEq of sodium bicarbonate A pound of baking soda or 96 teaspoons costs 1 which reduces the cost of a daily dosage of 60 mEq to less than a penny The cost of 60 mEq seven 650 mg Pills of Sodium Bicarbonate in pill form is 15 cents
Investigators hypothesize that the use of baking soda in stone formers with calcium oxalate associated hypocitraturia or with uric acid stones will increase urinary citrate and increase urine pH to the benefit of both patient groups If proven effective this approach could markedly lower the risk of stone formation in calcium oxalate and uric acid stone formers while providing an inexpensive solution on a global level to an otherwise very expensive and debilitating ailment
Kidney stones have varying compositions with the most common being calcium oxalate Uric acid stones are the third most common type of stone and account for 10 percent of all stone formers One of the common abnormalities for patients with calcium oxalate stones is low citrate levels in the urine Citrate is the primary inhibitor of calcium oxalate crystal formation growth and aggregation As such regimens to increase urinary citrate have been undertaken The most common drug used in this regard is potassium citrate ie Urocit K While effective the drug remains costly with prescription costs ranging as high as 450month With regard to uric acid stone formation a prerequisite is an acidic urine given that the pKa for uric acid is a pH of 55 once the pH is above 60 uric acid stones do not form Indeed the uric acid stone is the only one that can be dissolved if one is able to raise the pH to 65 -70
Current medical therapy for hypocitraturia in patients with calcium oxalate stones is the use of a slow-release tablet of potassium citrate eg UrocitK Current medical therapy for uric acid stone formers is likewise potassium citrate as it will raise the urine pH A prescription of potassium citrate with the typical dosage of 30 meq twice a day can cost the patient upwards of 450month Additionally potassium citrate tablets are associated with adverse effects such as nausea and diarrhea with additional concerns with respect to the potassium load among patients with poor renal function Furthermore the wax matrix tablets are large in size and difficult to swallow
Pinheiro et al in a prior study demonstrated that sodium bicarbonate in tablet form at a dose of 60 milliequivalent mEq per day was comparable to Urocit-K in increasing urinary pH and urinary citrate levels in calcium stone forming hypocitriuric patients The study was limited by a small sample size n16 and short duration of therapy 3 days Despite these favorable results over the ensuing decade there has been minimal interest in the use of sodium bicarbonate as a preventative treatment in stone formers who are hypocitriuric or uric acid stone formers
Baking soda is a common household item and is openly available throughout the world in most grocery stores The main component of baking soda is sodium bicarbonate Various studies have shown that a teaspoon of baking soda 48g has an equivalent of 59 mEq of sodium bicarbonate A pound of baking soda or 96 teaspoons costs 1 which reduces the cost of a daily dosage of 60 mEq to less than a penny The cost of 60 mEq seven 650 mg Pills of Sodium Bicarbonate in pill form is 15 cents
Investigators hypothesize that the use of baking soda in stone formers with calcium oxalate associated hypocitraturia or with uric acid stones will increase urinary citrate and increase urine pH to the benefit of both patient groups If proven effective this approach could markedly lower the risk of stone formation in calcium oxalate and uric acid stone formers while providing an inexpensive solution on a global level to an otherwise very expensive and debilitating ailment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None