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Effects of Potassium Citrate in Urine of Children With Elevated Calcium in Urine and Kidney Stones

NCT00120731 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2020-11-05

No results posted yet for this study

Summary

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.

Conditions

  • Kidney Calculi

Interventions

DRUG

Potassium Citrate

DRUG

Acetazolamide

BEHAVIORAL

Diet low in oxalate and purines

Sponsors & Collaborators

  • Children's Mercy Hospital Kansas City

    lead OTHER

Principal Investigators

  • Ari Auron, MD · Children's Mercy Hospital Kansas City

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
5 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2005-07-31
Completion
2007-05-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00120731 on ClinicalTrials.gov