Overview
Effects of Potassium Citrate in Urine of Children With Elevated Calcium in Urine and Kidney Stones
Status:
Withdrawn
Withdrawn
Trial end date:
2007-05-01
2007-05-01
Target enrollment:
0
0
Participant gender:
All
All
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.Phase:
N/AAccepts Healthy Volunteers?
Accepts Healthy VolunteersDetails
Lead Sponsor:
Children's Mercy Hospital Kansas CityTreatments:
Acetazolamide
Citric Acid
Potassium Citrate
Criteria
Inclusion Criteria:- 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.
Exclusion Criteria:
- 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