Effects of Potassium Citrate in Urine of Children With Elevated Calcium in Urine and Kidney Stones
|ClinicalTrials.gov Identifier: NCT00120731|
Recruitment Status : Completed
First Posted : July 19, 2005
Last Update Posted : June 15, 2007
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:
- children who are hypercalciuric stone formers;
- healthy children without a history of hypercalciuria or kidney stones.
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 or disease||Intervention/treatment||Phase|
|Kidney Calculi||Drug: Potassium Citrate Drug: Acetazolamide Behavioral: Diet low in oxalate and purines||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||23 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Urinary Chemistry and Acid-Base Effects of Potassium Citrate in Children With Idiopathic Hypercalciuria and Urolithiasis|
|Study Start Date :||July 2005|
|Actual Study Completion Date :||May 2007|
- Changes in urine pH, citrate, calcium and bicarbonate after treatment with increasing doses of potassium citrate [ Time Frame: Duration of protocol ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00120731
|United States, Missouri|
|The Children's Mercy Hospital|
|Kansas City, Missouri, United States, 64108|
|Principal Investigator:||Ari Auron, MD||The Children's Mercy Hospital|