Comparing Alkalinizing Agents Efficacy on Stone Risk in Patients on a Metabolically Controlled Diet

Официальное название

Evaluation of Multiple Alkalinizing Agents on Urinary Stone Risk Parameters in Stone and Non-stone Formers on a Metabolically Controlled Diet

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат Potassium citrate
  Slow release potassium citrate UroCit-K. Participants will take 20mEq twice daily.
• Препарат Sodium bicarbonate
  650mg tabs. Take 3 tabs twice daily.
• Пищевая добавка Litholyte
  One packet is taken with 170ml of water. Two packets daily.
• Пищевая добавка Crystal Lite
  The classic lemonade contains 21.7mEq/liter of alkali Therefore, patients will take 2 litres daily to have the 40mEq of alkali daily needed.
• Препарат Potassium Bicarbonate
  20 mEq tablets, one tablet twice daily

Первичные конечные точки

• 24 hour urine volume [Срок оценки: Change from baseline (Day 4) to initial start on treatment (Day 5)]
• 24 hour urine volume [Срок оценки: Change from baseline (Day 4) to end of study (day 12)]
• 24 hour urine creatinine [Срок оценки: Change from baseline (Day 4) to initial start on treatment (Day 5)]
• 24 hour urine creatinine [Срок оценки: Change from baseline (Day 4) to end of study (day 12)]
• 24 hour urine calcium [Срок оценки: Change from baseline (Day 4) to initial start on treatment (Day 5)]
• 24 hour urine calcium [Срок оценки: Change from baseline (Day 4) to end of study (day 12)]
• 24 hour urine potassium [Срок оценки: Change from baseline (Day 4) to initial start on treatment (Day 5)]
• 24 hour urine potassium [Срок оценки: Change from baseline (Day 4) to end of study (day 12)]
• 24 hour urine sodium [Срок оценки: Change from baseline (Day 4) to initial start on treatment (Day 5)]
• 24 hours urine sodium [Срок оценки: Change from baseline (Day 4) to end of study (day 12)]

Вторичные конечные точки (4)

• # of patient who adherence to 100% Medication [Срок оценки: At the end of study approximately 10 weeks after start of study.]
• Total out of pocket cost [Срок оценки: At the end of study approximately 10 weeks after start of study.]
• Patient's Satisfaction Survey [Срок оценки: At the end of study approximately 10 weeks after start of study.]
• Patient's GI Distress [Срок оценки: At the end of study approximately 10 weeks after start of study.]

Критерии участия

Критерии включения

• Adults aged 18 and older.
• with or without a history of stone disease.

Критерии исключения

• They are unable to take any of the medications due to health reasons.
• Participants are pregnant or nursing.
• Participants are unable to adhere to the metabolic diet.
• Participants had a prior adverse event from one or more of the medications.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Профилактика

Центры проведения

США · 1 центр

• University of Texas Southwestern Medical Center — Dallas

Публикации

• 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. PMID 22498635
• 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. PMID 2688503
• 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. PMID 24857648
• 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. PMID 3784284
• 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. PMID 9228722
• 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. PMID 4009822
• 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. PMID 9366314
• 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. PMID 3339718

Идентификаторы

NCT: NCT04651088 · STU-2020-0613

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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