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| Sponsor: | Children's Mercy Hospital Kansas City |
|---|---|
| Information provided by: | Children's Mercy Hospital Kansas City |
| ClinicalTrials.gov Identifier: | NCT00120731 |
Purpose
High amounts of calcium in the urine (hypercalciuria) can cause development of kidney stones in children. Treatment for these children includes plenty of fluids, a low-salt diet and medications such as potassium citrate. A major advantage of potassium citrate, as compared to hydrochlorothiazide, is its lack of side effects. One problem the researchers and others have observed is that some children continue to form kidney stones despite correction of hypercalciuria with potassium citrate. One possible explanation is that in some individuals potassium citrate therapy results in an excessive elevation of urine pH, a situation that may predispose to calcium phosphate stone formation. In this study, the researchers will study the effects of potassium citrate on urine chemistries and acid-base balance in three groups of children aged 5-17 years:
Particular attention will be paid to try to identify those who develop a very high urine pH (>8) and the factors leading to this metabolic reaction.
The researchers will try to learn whether it is the child’s characteristics, the disease manifestations, the dose of the drug, or a combination of the above which may be the cause of the development of very alkaline urine. Based on the results, the researchers hope to be able to better “tailor” the individual treatment for each child with kidney stones.
| Condition | Intervention |
|---|---|
|
Kidney Calculi |
Drug: Potassium Citrate Drug: Acetazolamide Behavioral: Diet low in oxalate and purines |
| Study Type: | Interventional |
| Study Design: | Diagnostic, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Efficacy Study |
| Official Title: | Urinary Chemistry and Acid-Base Effects of Potassium Citrate in Children With Idiopathic Hypercalciuria and Urolithiasis |
| Enrollment: | 23 |
| Study Start Date: | July 2005 |
| Study Completion Date: | May 2007 |
Hypercalciuria is a common clinical pediatric problem that in some children is associated with renal stones. Most renal stones (80%) are formed by calcium oxalate, calcium phosphate phases (apatite), and brushite (calcium monohydrogen phosphate). Hypercalciuria can be either primary (accounts for the vast majority of children with calcium stones) or secondary. Treatment for children with calcium stones involves non-pharmacological and pharmacological interventions. Non-pharmacological interventions include high fluid intake, low sodium, and potassium enhanced diet, with RDA calcium and protein. Historically, the specific treatment for hypercalciuric stone formers has included thiazides, which reduce calciuria, lower the urinary saturation of calcium oxalate and phosphate, and restore normal intestinal calcium absorption. However thiazides induce hypokalemia and hypocitraturia, and the latter attenuates the beneficial effects of the drug on stone formation. Currently, the drug of choice replacing thiazides in treating idiopathic hypercalciuria is potassium citrate. Potassium citrate is readily absorbed from the gastrointestinal tract, and after being excreted in the urine, it inhibits the crystallization of stone forming calcium salts by binding the calcium ion, thus decreasing its urinary saturation and inhibiting the nucleation and crystal growth of calcium oxalate; therefore, potassium citrate is an effective stone inhibitor agent. A major advantage of potassium citrate is its lack of side effects. One of the problems seen in clinical practice is that some children with primary hypercalciuria, even after the calciuria is treated successfully with potassium citrate, continue to develop stones. It has been suggested that an elevation in urine pH, seen in some patients treated with potassium citrate, may result in an alkaline urinary milieu which promotes calcium phosphate stone formation. In this study, the researchers plan to investigate the effects of potassium citrate on urine chemistries and acid-base balance in children who are hypercalciuric stone formers. The researchers will try to identify whether the beneficial effects of potassium citrate supplementation on lowering urine calcium and increasing citrate might be offset by too high urine pH (>8) which could promote the formation of calcium phosphate stones. Three groups of subjects aged 5-17 years will be studied: group 1 - idiopathic hypercalciuric stone formers; group 2 - idiopathic hypercalciuric non-stone formers; and group 3 - normocalciuric subjects. Three visits will be scheduled for each participant, and the subjects will receive two doses of potassium citrate. Urine chemistries and acid-base parameters will be measured. The researchers will try to learn whether it is the child’s characteristics, the disease manifestations, the dose of the drug, or a combination of the above which may be the cause of the development of very alkaline urine. Based on the study results, the researchers hope to be able to better “tailor” the individual treatment for each child with kidney stones due to idiopathic hypercalciuria.
Eligibility| Ages Eligible for Study: | 5 Years to 17 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Missouri | |
| The Children's Mercy Hospital | |
| Kansas City, Missouri, United States, 64108 | |
| Principal Investigator: | Ari Auron, MD | The Children's Mercy Hospital |
More Information
| Study ID Numbers: | RG#05036 |
| Study First Received: | July 12, 2005 |
| Last Updated: | June 14, 2007 |
| ClinicalTrials.gov Identifier: | NCT00120731 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Recurrent nephrolithiasis Potassium Citrate Hypercalciuria Distal Renal Tubular Acidosis Nephrolithiasis in children |
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Pathological Conditions, Anatomical Respiratory System Agents Urinary Calculi Molecular Mechanisms of Pharmacological Action Urolithiasis Hematologic Agents Diuretics Physiological Effects of Drugs Acetazolamide Calculi Signs and Symptoms Potassium Citrate Urologic Diseases Therapeutic Uses Kidney Diseases |
Kidney Calculi Anticoagulants Citric Acid Enzyme Inhibitors Cardiovascular Agents Pharmacologic Actions Urological Manifestations Carbonic Anhydrase Inhibitors Natriuretic Agents Expectorants Hypercalciuria Chelating Agents Nephrolithiasis Central Nervous System Agents Anticonvulsants |