Calcium Phosphate Kidney StonesPhase 2NCT01754779
Treatment for Calcium Phosphate Kidney Stone Disease
A Phase 2 study testing Citric Acid and Potassium Citrate in people with Calcium Phosphate Kidney Stones, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
The investigators will examine in two studies whether citric acid or potassium citrate can reduce calcium phosphate saturation in urine of Calcium Phosphate stone formers. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Calcium Phosphate Kidney Stones
- What is being tested?
- Citric Acid and Potassium Citrate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2012to 16 Feb 2023
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aim 1
- Hypocitraturic CaP stone formers
- urine citrate <320mg/d
- elevated pH as 24-hr urine pH above 6.40
- >21 years
- Aim 2
Show all 10Show fewer
- Hypercalciuric CaP stone formers
- 24hr urine calcium >250mg/d in women and >300mg/d in men prior to indapamide use
- high pH as >6.40 in the absence of urinary tract infection
- >21 years
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
UT Southwestern Medical Center
Dallas, Texas, 75390-8885
About this study
Official title: Pharmacological Therapy for Calcium Phosphate Urolithiasis
The investigators will examine in two studies whether citric acid or potassium citrate can reduce calcium phosphate saturation in urine of Calcium Phosphate stone formers.
Read the detailed description
We will examine in two short-term placebo-controlled cross-over metabolic studies whether citric acid or potassium citrate can reduce calcium phosphate saturation in urine of CaP stone formers.
The first study will be conducted in hypocitraturic CaP stone formers without hypercalciuria, and will compare the effects of potassium citrate, citric acid and placebo.
The second study will be conducted in hypercalciuric CaP stone formers on a thiazide diuretic who require potassium supplementation, and will compare the effects of potassium chloride alone, potassium chloride + citric acid, and potassium citrate alone. Physicochemical assays will be applied in addition to computer-based stone risk prediction programs to assess risk of stone recurrence.
- Conditions
- Calcium Phosphate Kidney Stones
- Being tested
- Placebo, Citric Acid, Potassium Citrate
- Keywords
- calcium phosphate, urolithiasis, kidney stones, hypercalciuria
- Medical subject headings
- Urolithiasis, Kidney Calculi, Hypercalciuria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDietary supplement
3 tablets twice daily of matching placebo during the placebo phase.
Citric AcidDietary supplement
3, 10 mEq tablets of H3Cit twice daily during the H3Cit phase (60 mEq H3Cit per day)
Potassium CitrateDietary supplement
2, 10 mEq K3Cit tablets and 1 placebo tablet twice daily during the K3Cit phase (40 mEq K3Cit per day)
| Study group | Role | What they receive |
|---|---|---|
| Placebo, then Citric Acid, then Potassium Citrate | Experimental | Participants will receive at random, First intervention (1 week), then experience a washout period (1 week) and then receive Second Intervention (1 week) followed by another washout period of 1 week to finally receive the Third Intervention (1 week) Receives: Dietary Supplement: Placebo; Dietary Supplement: Citric Acid; Dietary Supplement: Potassium Citrate |
| Placebo, then Potassium Citrate, then Citric Acid | Experimental | Participants will receive at random, First intervention (1 week), then experience a washout period (1 week) and then receive Second Intervention (1 week) followed by another washout period of 1 week to finally receive the Third Intervention (1 week) Receives: Dietary Supplement: Placebo; Dietary Supplement: Citric Acid; Dietary Supplement: Potassium Citrate |
| Potassium Citrate, then Placebo, then Citric Acid | Experimental | Participants will receive at random, First intervention (1 week), then experience a washout period (1 week) and then receive Second Intervention (1 week) followed by another washout period of 1 week to finally receive the Third Intervention (1 week) Receives: Dietary Supplement: Placebo; Dietary Supplement: Citric Acid; Dietary Supplement: Potassium Citrate |
| Potassium Citrate, then Citric Acid, then Placebo | Experimental | Participants will receive at random, First intervention (1 week), then experience a washout period (1 week) and then receive Second Intervention (1 week) followed by another washout period of 1 week to finally receive the Third Intervention (1 week) Receives: Dietary Supplement: Placebo; Dietary Supplement: Citric Acid; Dietary Supplement: Potassium Citrate |
| Citric Acid, then Potassium Citrate, then Placebo | Experimental | Participants will receive at random, First intervention (1 week), then experience a washout period (1 week) and then receive Second Intervention (1 week) followed by another washout period of 1 week to finally receive the Third Intervention (1 week) Receives: Dietary Supplement: Placebo; Dietary Supplement: Citric Acid; Dietary Supplement: Potassium Citrate |
| Citric Acid, then Placebo, then Potassium Citrate | Experimental | Participants will receive at random, First intervention (1 week), then experience a washout period (1 week) and then receive Second Intervention (1 week) followed by another washout period of 1 week to finally receive the Third Intervention (1 week) Receives: Dietary Supplement: Placebo; Dietary Supplement: Citric Acid; Dietary Supplement: Potassium Citrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary Calcium Phosphate Saturation
This variable represents a ratio of the calcium phosphate saturation in a given urine sample to the calcium phosphate saturation at the point of precipitation and hence this measure has no units.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2012 (estimated)
- Study startJul 2012
- Primary completion16 Feb 2023
- Study completion16 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Calcium Phosphate Kidney StonesStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Naim Maalouf, University of Texas Southwestern Medical Center
- Investigators
- Naim M Maalouf, MD, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01754779
- Sponsor's protocol ID
- 032012-058
- Other IDs
- R21DK097476-01
- Status last verified
- Mar 2024
- First submitted
- 14 Dec 2012
- Last updated
- 4 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Doizi S, Poindexter JR, Pearle MS, Blanco F, Moe OW, Sakhaee K, Maalouf NM. Impact of Potassium Citrate vs Citric Acid on Urinary Stone Risk in Calcium Phosphate Stone Formers. J Urol. 2018 Dec;200(6):1278-1284. doi: 10.1016/j.juro.2018.07.039. Epub 2018 Jul 20.
PubMed 30036516
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacological Therapy for Calcium Phosphate Urolithiasis
- ClinicalTrials.gov ID
- NCT01754779
- Acronym / sponsor ID
- 032012-058
- Conditions
- Calcium Phosphate Kidney Stones
- Keywords
- calcium phosphate, urolithiasis, kidney stones, hypercalciuria
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Jul 2012 (actual)
- Primary completion
- 16 Feb 2023 (actual)
- Study completion
- 16 Feb 2023 (actual)
- First posted
- 21 Dec 2012 (estimated)
- Results
- Posted 4 Apr 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators will examine in two studies whether citric acid or potassium citrate can reduce calcium phosphate saturation in urine of Calcium Phosphate stone formers.
Detailed description
We will examine in two short-term placebo-controlled cross-over metabolic studies whether citric acid or potassium citrate can reduce calcium phosphate saturation in urine of CaP stone formers.
The first study will be conducted in hypocitraturic CaP stone formers without hypercalciuria, and will compare the effects of potassium citrate, citric acid and placebo.
The second study will be conducted in hypercalciuric CaP stone formers on a thiazide diuretic who require potassium supplementation, and will compare the effects of potassium chloride alone, potassium chloride + citric acid, and potassium citrate alone. Physicochemical assays will be applied in addition to computer-based stone risk prediction programs to assess risk of stone recurrence.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Placebo, then Citric Acid, then Potassium Citrate | Experimental | Dietary Supplement: Placebo, Dietary Supplement: Citric Acid, Dietary Supplement: Potassium CitrateParticipants will receive at random, First intervention (1 week), then experience a washout period (1 week) and then receive Second Intervention (1 week) followed by another washout period of 1 week to finally receive the Third Intervention (1 week) |
| Placebo, then Potassium Citrate, then Citric Acid | Experimental | Dietary Supplement: Placebo, Dietary Supplement: Citric Acid, Dietary Supplement: Potassium CitrateParticipants will receive at random, First intervention (1 week), then experience a washout period (1 week) and then receive Second Intervention (1 week) followed by another washout period of 1 week to finally receive the Third Intervention (1 week) |
| Potassium Citrate, then Placebo, then Citric Acid | Experimental | Dietary Supplement: Placebo, Dietary Supplement: Citric Acid, Dietary Supplement: Potassium CitrateParticipants will receive at random, First intervention (1 week), then experience a washout period (1 week) and then receive Second Intervention (1 week) followed by another washout period of 1 week to finally receive the Third Intervention (1 week) |
| Potassium Citrate, then Citric Acid, then Placebo | Experimental | Dietary Supplement: Placebo, Dietary Supplement: Citric Acid, Dietary Supplement: Potassium CitrateParticipants will receive at random, First intervention (1 week), then experience a washout period (1 week) and then receive Second Intervention (1 week) followed by another washout period of 1 week to finally receive the Third Intervention (1 week) |
| Citric Acid, then Potassium Citrate, then Placebo | Experimental | Dietary Supplement: Placebo, Dietary Supplement: Citric Acid, Dietary Supplement: Potassium CitrateParticipants will receive at random, First intervention (1 week), then experience a washout period (1 week) and then receive Second Intervention (1 week) followed by another washout period of 1 week to finally receive the Third Intervention (1 week) |
| Citric Acid, then Placebo, then Potassium Citrate | Experimental | Dietary Supplement: Placebo, Dietary Supplement: Citric Acid, Dietary Supplement: Potassium CitrateParticipants will receive at random, First intervention (1 week), then experience a washout period (1 week) and then receive Second Intervention (1 week) followed by another washout period of 1 week to finally receive the Third Intervention (1 week) |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Aim 1
- Hypocitraturic CaP stone formers
- urine citrate <320mg/d
- elevated pH as 24-hr urine pH above 6.40
- >21 years
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Placebo3 tablets twice daily of matching placebo during the placebo phase. | Dietary supplement | Citric Acid, then Placebo, then Potassium Citrate, Citric Acid, then Potassium Citrate, then Placebo, Placebo, then Citric Acid, then Potassium Citrate, Placebo, then Potassium Citrate, then Citric Acid, Potassium Citrate, then Citric Acid, then Placebo, Potassium Citrate, then Placebo, then Citric Acid |
| Citric Acid3, 10 mEq tablets of H3Cit twice daily during the H3Cit phase (60 mEq H3Cit per day) | Dietary supplement | Citric Acid, then Placebo, then Potassium Citrate, Citric Acid, then Potassium Citrate, then Placebo, Placebo, then Citric Acid, then Potassium Citrate, Placebo, then Potassium Citrate, then Citric Acid, Potassium Citrate, then Citric Acid, then Placebo, Potassium Citrate, then Placebo, then Citric Acid |
| Potassium Citrate2, 10 mEq K3Cit tablets and 1 placebo tablet twice daily during the K3Cit phase (40 mEq K3Cit per day) | Dietary supplement | Citric Acid, then Placebo, then Potassium Citrate, Citric Acid, then Potassium Citrate, then Placebo, Placebo, then Citric Acid, then Potassium Citrate, Placebo, then Potassium Citrate, then Citric Acid, Potassium Citrate, then Citric Acid, then Placebo, Potassium Citrate, then Placebo, then Citric Acid |
Primary outcome
Urinary Calcium Phosphate Saturation
Time frame: 2 weeks
This variable represents a ratio of the calcium phosphate saturation in a given urine sample to the calcium phosphate saturation at the point of precipitation and hence this measure has no units.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 30036516Doizi S, Poindexter JR, Pearle MS, Blanco F, Moe OW, Sakhaee K, Maalouf NM. Impact of Potassium Citrate vs Citric Acid on Urinary Stone Risk in Calcium Phosphate Stone Formers. J Urol. 2018 Dec;200(6):1278-1284. doi: 10.1016/j.juro.2018.07.039. Epub 2018 Jul 20.
- Individual participant dataSharing planned: No
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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.
Naim M Maalouf, MD principal investigator
University of Texas Southwestern Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Citric Acid and Potassium Citrate in people with Calcium Phosphate Kidney Stones, run by University of Texas Southwestern Medical Center 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 10 inclusion and 0 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: finished, as of the sponsor's last update on 4 Apr 2024. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Urinary Calcium Phosphate Saturation (time frame: 2 weeks). 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 NCT01754779, 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 4 Apr 2024.