NCT00120731

Brief 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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 2005

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2005

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

July 12, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 19, 2005

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2007

Completed
Last Updated

November 5, 2020

Status Verified

November 1, 2020

First QC Date

July 12, 2005

Last Update Submit

November 3, 2020

Conditions

Kidney Calculi

Keywords

Recurrent nephrolithiasisPotassium CitrateHypercalciuriaDistal Renal Tubular AcidosisNephrolithiasis in children

Outcome Measures

Primary Outcomes (1)

  • Changes in urine pH, citrate, calcium and bicarbonate after treatment with increasing doses of potassium citrate

    Duration of protocol

Interventions

Potassium CitrateDRUG
AcetazolamideDRUG
Diet low in oxalate and purinesBEHAVIORAL

Eligibility Criteria

Age5 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Children's Mercy Hospital

Kansas City, Missouri, 64108, United States

Location

Related Publications (1)

  • Tapaneya-Olarn W, Khositseth S, Tapaneya-Olarn C, Teerakarnjana N, Chaichanajarernkul U, Stitchantrakul W, Petchthong T. The optimal dose of potassium citrate in the treatment of children with distal renal tubular acidosis. J Med Assoc Thai. 2002 Nov;85 Suppl 4:S1143-9.

    PMID: 12549788BACKGROUND

MeSH Terms

Conditions

Kidney CalculiNephrolithiasisHypercalciuriaAcidosis, Renal Tubular

Interventions

Potassium CitrateAcetazolamideOxalatesPurines

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrolithiasisUrinary CalculiMale Urogenital DiseasesCalculiPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsUrological ManifestationsSigns and SymptomsRenal Tubular Transport, Inborn ErrorsGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesAcidosisAcid-Base ImbalanceMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Citric AcidCitratesTricarboxylic AcidsAcids, AcyclicCarboxylic AcidsOrganic ChemicalsThiadiazolesThiazolesSulfur CompoundsAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsDicarboxylic AcidsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Ari Auron, MD

    Children's Mercy Hospital Kansas City

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 12, 2005

First Posted

July 19, 2005

Study Start

July 1, 2005

Study Completion

May 1, 2007

Last Updated

November 5, 2020

Record last verified: 2020-11

Locations

US(1)