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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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
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.
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.
- First posted19 Jul 2005 (estimated)
- Study startJul 2005
- Study completionMay 2007
Why it stopped: Determined not feasible
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Kidney CalculiStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Children's Mercy Hospital Kansas City
- Sponsor type
- University, hospital or other
- Investigators
- Ari Auron, MD, Principal investigator, Children's Mercy Hospital Kansas City
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
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Urinary Chemistry and Acid-Base Effects of Potassium Citrate in Children With Idiopathic Hypercalciuria and Urolithiasis
- ClinicalTrials.gov ID
- NCT00120731
- Acronym / sponsor ID
- RG#05036
- Conditions
- Kidney Calculi
- Keywords
- Recurrent nephrolithiasis, Potassium Citrate, Hypercalciuria, Distal Renal Tubular Acidosis, Nephrolithiasis in children
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Determined not feasible
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Children's Mercy Hospital Kansas CityUniversity, hospital or other
- Study start
- Jul 2005
- Study completion
- May 2007 (actual)
- First posted
- 19 Jul 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 5 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Potassium Citrate | Drug | – |
| Acetazolamide | Drug | – |
| Diet low in oxalate and purines | Behavioural | – |
Primary outcome
Changes in urine pH, citrate, calcium and bicarbonate after treatment with increasing doses of potassium citrate
Time frame: Duration of protocol
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2020.
- Background: PubMed 12549788Tapaneya-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.
Related trials for Kidney Calculi
Not yet recruiting
Automated Versus Manual Irrigation During Flexible Ureteroscopy
Renal Stone Disease
Not yet recruiting
Optimal Intrarenal Pressure During Flexible Ureteroscopy
Renal Stone Disease
RecruitingObservational study
Stone Clearance With Aspiration vs Other Technologies: a Real-world Evidence Study
Urolithiasis, Stones, Kidney
Not yet recruiting
Intertransverse Process Block Versus Erector Spinae Plane Block for Postoperative Analgesia After Percutaneous Nephrolithotomy
Kidney Stones, Urolithiasis, Hypocitraturia, Pain, Postoperative
Not yet recruiting
Comparison of Smart Pressure-Controlled Flexible Ureteroscopy and Flexible Suction Ureteral Access Sheath-Assisted Flexible Ureteroscopy for 2-3 cm Renal Stones
Kidney Stones
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ari Auron, MD principal investigator
Children's Mercy Hospital Kansas City
1 site in 1 country: see every site and its status.
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.