Effects of Potassium Citrate in Urine of Children With Elevated Calcium in Urine and Kidney Stones
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|ClinicalTrials.gov Identifier: NCT00120731|
Recruitment Status : Withdrawn (Determined not feasible)
First Posted : July 19, 2005
Last Update Posted : November 5, 2020
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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 :||0 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 ]
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|Ages Eligible for Study:||5 Years to 17 Years (Child)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
- Children aged 5-17 years with idiopathic hypercalciuria who have history of kidney stones.
- Healthy children aged 5-17 years without a history of hypercalciuria or kidney stones.
- Children with urolithiasis secondary to metabolic disorders unrelated to hypercalciuria (e.g. oxaluria, hypocitraturia, cystinuria), or due to secondary causes of calciuria (hypercalcemia, hyperparathyroidism, corticosteroids, furosemide).
- Children with renal insufficiency, active urinary tract infection, hyperkalemia, gastrointestinal diseases, heart failure.
- Children who receive angiotensin-converting enzyme inhibitors, anticholinergic medications or digitalis.
- Children who cannot safely stop receiving the prohibited concomitant medications due to other underlying medical conditions
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||Children's Mercy Hospital Kansas City|
|Other Study ID Numbers:||
|First Posted:||July 19, 2005 Key Record Dates|
|Last Update Posted:||November 5, 2020|
|Last Verified:||November 2020|
Distal Renal Tubular Acidosis
Nephrolithiasis in children
Pathological Conditions, Anatomical
Molecular Mechanisms of Pharmacological Action
Carbonic Anhydrase Inhibitors
Physiological Effects of Drugs
Respiratory System Agents