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The purpose of this study is to compare over the counter and alternative prescription urinary alkalinizing agents to slow release potassium citrate in their ability to modify urinary parameters associated with stone formation.
Kidney stones are a common medical problem, occurring in almost 10% of people in the United States1. Furthermore, 50% of patients will recur within 10 years2. Metabolic testing is advised in recurrent stone formers, as well as those considered high risk, to assess for a specific abnormality which may prompt intervention to prevent future stone formation. Non-surgical interventions include both dietary counselling, as well as pharmacotherapy.
One of the most commonly prescribed class of pharmacotherapies is alkali therapy which can be used to both increase the urinary pH and raise the urine citrate levels. This is particularly useful as correction of very acidic urinary pH (<5.5) can counteract uric acid crystallization thereby preventing or even dissolving uric acid stones3. Further, citrate has been shown to be a potent inhibitor of calcium stones by binding to the calcium directly4 and inhibiting crystal nucleation, thereby reducing calcium stone formation5,6.
The most commonly utilized preparation of alkali therapy is potassium citrate which has been shown to prevent stone formation better than sodium citrate7. Unfortunately, some forms of potassium citrate (crystal packets) have become unavailable, and the slow release form of potassium citrate (UroCit-K) now exceeds $15/day in cost8. There have been multiple alternative alkali therapies that have been used in place of potassium citrate, including both medical foods and prescription medications, but with little evidence to support their use. A pilot study in order to quantify the metabolic effects of these agents and compare them to potassium citrate will be performed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Metabolic diet | Placebo Comparator | Controlled metabolic diet arm. |
|
| Potassium citrate | Active Comparator |
| |
| Sodium Bicarbonate | Active Comparator |
| |
| Litholyte arm | Active Comparator |
| |
| Crystal Lite | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Potassium citrate | Drug | Slow release potassium citrate UroCit-K. Participants will take 20mEq twice daily. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 24 hour urine volume | Total urine volume | Change from baseline (Day 4) to initial start on treatment (Day 5) |
| 24 hour urine volume | Total urine volume | Change from baseline (Day 4) to end of study (day 12) |
| 24 hour urine creatinine | Urine creatinine | Change from baseline (Day 4) to initial start on treatment (Day 5) |
| 24 hour urine creatinine | Urine creatinine | Change from baseline (Day 4) to end of study (day 12) |
| 24 hour urine calcium | urine calcium | Change from baseline (Day 4) to initial start on treatment (Day 5) |
| 24 hour urine calcium | urine calcium | Change from baseline (Day 4) to end of study (day 12) |
| 24 hour urine potassium | Urine potassium | Change from baseline (Day 4) to initial start on treatment (Day 5) |
| 24 hour urine potassium | Urine potassium | Change from baseline (Day 4) to end of study (day 12) |
| Measure | Description | Time Frame |
|---|---|---|
| # of patient who adherence to 100% Medication | Patient's adherence to medication for duration of study. | At the end of study approximately 10 weeks after start of study. |
| Total out of pocket cost |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Brett A Johnson, MD | Contact | 214-648-6853 | brett.johnson@utsouthwestern.edu | |
| Ashley Gonzalez, MD | Contact | ashley.gonzalez2@utsouthwestern.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22498635 | Background | Scales CD Jr, Smith AC, Hanley JM, Saigal CS; Urologic Diseases in America Project. Prevalence of kidney stones in the United States. Eur Urol. 2012 Jul;62(1):160-5. doi: 10.1016/j.eururo.2012.03.052. Epub 2012 Mar 31. | |
| 2688503 | Background | Uribarri J, Oh MS, Carroll HJ. The first kidney stone. Ann Intern Med. 1989 Dec 15;111(12):1006-9. doi: 10.7326/0003-4819-111-12-1006. |
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| Potassium Bicarbonate | Active Comparator |
|
| Sodium bicarbonate | Drug | 650mg tabs. Take 3 tabs twice daily. |
|
| Litholyte | Dietary Supplement | One packet is taken with 170ml of water. Two packets daily. |
|
| Crystal Lite | Dietary Supplement | The classic lemonade contains 21.7mEq/liter of alkali Therefore, patients will take 2 litres daily to have the 40mEq of alkali daily needed. |
|
| Potassium Bicarbonate | Drug | 20 mEq tablets, one tablet twice daily |
|
| 24 hour urine sodium | Urine sodium | Change from baseline (Day 4) to initial start on treatment (Day 5) |
| 24 hours urine sodium | Urine sodium | Change from baseline (Day 4) to end of study (day 12) |
| 24 hours urine citrate | Urine citrate | Change from baseline (Day 4) to initial start on treatment (Day 5) |
| 24 hours urine citrate | Urine citrate | Change from baseline (Day 4) to end of study (day 12) |
| 24 hours urine uric acid | Urine uric acid | Change from baseline (Day 4) to initial start on treatment (Day 5) |
| 24 hours urine uric acid | Urine Uric Acid | Change from baseline (Day 4) to end of study (day 12) |
| 24 hours urine oxalate | Urine oxalate | Change from baseline (Day 4) to initial start on treatment (Day 5) |
| 24 hours urine oxalate | Urine oxalate | Change from baseline (Day 4) to end of study (day 12) |
| 24 hours urine magnesium | Urine magnesium | Change from baseline (Day 4) to initial start on treatment (Day 5) |
| 24 hours urine magnesium | Urine magnesium | Change from baseline (Day 4) to end of study (day 12) |
| 24 hours urine ammonia | Urine ammonia | Change from baseline (Day 4) to initial start on treatment (Day 5) |
| 24 hours urine ammonia | Urine ammonia | Change from baseline (Day 4) to end of study (day 12) |
| 24 Hour Urine pH | Overal Urine pH from 24h urine sample. | Change from baseline (Day 4) to initial start on treatment (Day 5) |
| 24 Hour Urine pH | Overal Urine pH from 24h urine sample. | Change from baseline (Day 4) to end of study (day 12) |
| 24 hour urine phosphorus | Urine phosphorus | Change from baseline (Day 4) to initial start on treatment (Day 5) |
| 24 hour urine phosphorus | Urine phosphorus | Change from baseline (Day 4) to end of study (day 12) |
| 24 hour urine sulfate | Urine sulfate | Change from baseline (Day 4) to initial start on treatment (Day 5) |
| 24 hour urine sulfate | Urine sulfate | Change from baseline (Day 4) to end of study (day 12) |
Calculate and compare treatment costs for the different interventions (in American dollars).
| At the end of study approximately 10 weeks after start of study. |
| Patient's Satisfaction Survey | Patient satisfaction survey, adapted from the Treatment Satisfaction Questionnaire for Medication-14. Patients are queried on their satisfaction, with 9 questions for each medication. | At the end of study approximately 10 weeks after start of study. |
| Patient's GI Distress | Patient's GI distress symptom scale measures patients GI distress. There are 18 questions with descriptive answers ranging from "none", "mild", "moderate", "quite a lot" and "unbearable". There are no numerical scores, rather just descriptive scores. "None" means no GI distress, "unbearable" means that you are in a lot of distress from your GI symptoms. | At the end of study approximately 10 weeks after start of study. |
| 24857648 | Background | Pearle MS, Goldfarb DS, Assimos DG, Curhan G, Denu-Ciocca CJ, Matlaga BR, Monga M, Penniston KL, Preminger GM, Turk TM, White JR; American Urological Assocation. Medical management of kidney stones: AUA guideline. J Urol. 2014 Aug;192(2):316-24. doi: 10.1016/j.juro.2014.05.006. Epub 2014 May 20. |
| 3784284 | Background | Pak CY, Sakhaee K, Fuller C. Successful management of uric acid nephrolithiasis with potassium citrate. Kidney Int. 1986 Sep;30(3):422-8. doi: 10.1038/ki.1986.201. |
| 9228722 | Background | Ryall RL. Urinary inhibitors of calcium oxalate crystallization and their potential role in stone formation. World J Urol. 1997;15(3):155-64. doi: 10.1007/BF02201852. No abstract available. |
| 4009822 | Background | Preminger GM, Sakhaee K, Skurla C, Pak CY. Prevention of recurrent calcium stone formation with potassium citrate therapy in patients with distal renal tubular acidosis. J Urol. 1985 Jul;134(1):20-3. doi: 10.1016/s0022-5347(17)46963-1. |
| 9366314 | Background | Ettinger B, Pak CY, Citron JT, Thomas C, Adams-Huet B, Vangessel A. Potassium-magnesium citrate is an effective prophylaxis against recurrent calcium oxalate nephrolithiasis. J Urol. 1997 Dec;158(6):2069-73. doi: 10.1016/s0022-5347(01)68155-2. |
| 3339718 | Background | Preminger GM, Sakhaee K, Pak CY. Alkali action on the urinary crystallization of calcium salts: contrasting responses to sodium citrate and potassium citrate. J Urol. 1988 Feb;139(2):240-2. doi: 10.1016/s0022-5347(17)42374-3. |
| 31333065 | Background | Stern KL, Canvasser N, Borofsky M, Gleason VM, Kamphuis G, El Tayeb MM, Hsi R, Scotland KB. Alkalinizing Agents: A Review of Prescription, Over-the-Counter, and Medical Food Supplements. J Endourol. 2020 Jan;34(1):1-6. doi: 10.1089/end.2019.0292. Epub 2019 Sep 25. |
| ID | Term |
|---|---|
| D007669 | Kidney Calculi |
| ID | Term |
|---|---|
| D053040 | Nephrolithiasis |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052878 | Urolithiasis |
| D014545 | Urinary Calculi |
| D052801 | Male Urogenital Diseases |
| D002137 | Calculi |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D019357 | Potassium Citrate |
| D017693 | Sodium Bicarbonate |
| C026329 | potassium bicarbonate |
| ID | Term |
|---|---|
| D019343 | Citric Acid |
| D002951 | Citrates |
| D014233 | Tricarboxylic Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D001639 | Bicarbonates |
| D002254 | Carbonates |
| D002255 | Carbonic Acid |
| D017554 | Carbon Compounds, Inorganic |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
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