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Kidney CalculiNCT00120731

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

A study testing Potassium Citrate, Acetazolamide and Diet low in oxalate and purines in people with Kidney Calculi, run by Children's Mercy Hospital Kansas City at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 5 to 17 yearsHealthy volunteers can take part
Conditions the study is for
Kidney Calculi
What is being tested?
Potassium Citrate, Acetazolamide and Diet low in oxalate and purines
How many people
0 participants
Where
1 siteUnited States
Study dates
Jul 2005to May 2007
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 5 to 17 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • The Children's Mercy Hospital

    Kansas City, Missouri, 64108

Other trials in United States

About this study

Official title: Urinary Chemistry and Acid-Base Effects of Potassium Citrate in Children With Idiopathic Hypercalciuria and Urolithiasis

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.
Read more

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.

Read the detailed description

Hypercalciuria is a common clinical pediatric problem that in some children is associated with renal stones. Most renal stones (80%) are formed by calcium oxalate, calcium phosphate phases (apatite), and brushite (calcium monohydrogen phosphate). Hypercalciuria can be either primary (accounts for the vast majority of children with calcium stones) or secondary. Treatment for children with calcium stones involves non-pharmacological and pharmacological interventions. Non-pharmacological interventions include high fluid intake, low sodium, and potassium enhanced diet, with RDA calcium and protein. Historically, the specific treatment for hypercalciuric stone formers has included thiazides, which reduce calciuria, lower the urinary saturation of calcium oxalate and phosphate, and restore normal intestinal calcium absorption. However thiazides induce hypokalemia and hypocitraturia, and the latter attenuates the beneficial effects of the drug on stone formation. Currently, the drug of choice replacing thiazides in treating idiopathic hypercalciuria is potassium citrate. Potassium citrate is readily absorbed from the gastrointestinal tract, and after being excreted in the urine, it inhibits the crystallization of stone forming calcium salts by binding the calcium ion, thus decreasing its urinary saturation and inhibiting the nucleation and crystal growth of calcium oxalate; therefore, potassium citrate is an effective stone inhibitor agent. A major advantage of potassium citrate is its lack of side effects. One of the problems seen in clinical practice is that some children with primary hypercalciuria, even after the calciuria is treated successfully with potassium citrate, continue to develop stones. It has been suggested that an elevation in urine pH, seen in some patients treated with potassium citrate, may result in an alkaline urinary milieu which promotes calcium phosphate stone formation. In this study, the researchers plan to investigate the effects of potassium citrate on urine chemistries and acid-base balance in children who are hypercalciuric stone formers. The researchers will try to identify whether the beneficial effects of potassium citrate supplementation on lowering urine calcium and increasing citrate might be offset by too high urine pH (>8) which could promote the formation of calcium phosphate stones. Three groups of subjects aged 5-17 years will be studied: group 1 - idiopathic hypercalciuric stone formers; group 2 - idiopathic hypercalciuric non-stone formers; and group 3 - normocalciuric subjects. Three visits will be scheduled for each participant, and the subjects will receive two doses of potassium citrate. Urine chemistries and acid-base parameters will be measured. 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 study results, the researchers hope to be able to better "tailor" the individual treatment for each child with kidney stones due to idiopathic hypercalciuria.

Conditions
Kidney Calculi
Being tested
Potassium Citrate, Acetazolamide, Diet low in oxalate and purines
Keywords
Recurrent nephrolithiasis, Potassium Citrate, Hypercalciuria, Distal Renal Tubular Acidosis, Nephrolithiasis in children
Medical subject headings
Kidney Calculi, Nephrolithiasis, Hypercalciuria, Acidosis, Renal Tubular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Potassium CitrateDrug

  • AcetazolamideDrug

  • Diet low in oxalate and purinesBehavioural

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Duration of protocol

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jul 2005 (estimated)
  2. Study startJul 2005
  3. Study completionMay 2007

Why it stopped: Determined not feasible

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00120731
Sponsor's protocol ID
RG#05036
Status last verified
Nov 2020
First submitted
12 Jul 2005
Last updated
5 Nov 2020
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 12549788

Questions about this trial

What is this clinical trial studying?

A study testing Potassium Citrate, Acetazolamide and Diet low in oxalate and purines in people with Kidney Calculi, run by Children's Mercy Hospital Kansas City at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 5 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in urine pH, citrate, calcium and bicarbonate after treatment with increasing doses of potassium citrate (time frame: Duration of protocol). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00120731, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2020.

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