Kidney StoneNCT03281928
Effect of Dietary Sodium and Potassium Citrate on Renal Mineral Handling
A study testing Sodium and Potassium Citrate in people with Kidney Stone, run by University of Chicago at 1 site in United States.
Trial summary
This study intends to characterize the affect of sodium and potassium citrate in the diet on renal function. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Kidney Stone
- What is being tested?
- Sodium and Potassium Citrate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2017to 15 Nov 2022
- 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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age 18 - 70, approximately equal numbers of men and women
- studied by endoscopy with complete papillary mapping and grading
- stone formers
Who cannot join
- Patients with primary renal diseases or renal impairment (eGFR < 90), or medical conditions such as diabetes, or systemic diseases or medications that alter calcium metabolism
- Patients with known bladder voiding problems
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Chicago Medical Center
Chicago, Illinois, 60637
About this study
This study intends to characterize the affect of sodium and potassium citrate in the diet on renal function.
- Conditions
- Kidney Stone
- Being tested
- Sodium and Potassium Citrate, Placebo
- Medical subject headings
- Kidney Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium and Potassium CitrateDietary supplement
Sodium and potassium citrate levels will be altered in diet and renal mineral handling will be measured as compared to placebo.
PlaceboDietary supplement
Sodium without Potassium Citrate
| Study group | Role | What they receive |
|---|---|---|
| Low Sodium plus Potassium Citrate | Experimental | Not described Receives: Dietary Supplement: Sodium and Potassium Citrate |
| Low Sodium plus placebo | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
| High Sodium plus Potassium Citrate | Experimental | Not described Receives: Dietary Supplement: Sodium and Potassium Citrate |
| High Sodium plus placebo | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urine Calcium levels
Amount of calcium in the urine will be measured
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2017
- Study start1 Oct 2017
- Primary completion15 Nov 2022
- Study completion15 Nov 2022
Why it stopped: Study closed due to IRB expiration. A new protocol (IRB22-1817) was submitted to continue the research.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney StoneStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03281928
- Sponsor's protocol ID
- IRB17-0992
- Status last verified
- Apr 2025
- First submitted
- 8 Sep 2017
- Last updated
- 22 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Dietary Sodium and Potassium Citrate on Renal Mineral Handling
- ClinicalTrials.gov ID
- NCT03281928
- Acronym / sponsor ID
- IRB17-0992
- Conditions
- Kidney Stone
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study closed due to IRB expiration. A new protocol (IRB22-1817) was submitted to continue the research.
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 15 Nov 2022 (actual)
- Study completion
- 15 Nov 2022 (actual)
- First posted
- 13 Sep 2017 (actual)
- 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.
This study intends to characterize the affect of sodium and potassium citrate in the diet on renal function.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Low Sodium plus Potassium Citrate | Experimental | Dietary Supplement: Sodium and Potassium Citrate |
| Low Sodium plus placebo | Placebo comparator | Dietary Supplement: Placebo |
| High Sodium plus Potassium Citrate | Experimental | Dietary Supplement: Sodium and Potassium Citrate |
| High Sodium plus placebo | Placebo comparator | Dietary Supplement: Placebo |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age 18 - 70, approximately equal numbers of men and women
- studied by endoscopy with complete papillary mapping and grading
- stone formers
Key exclusion criteria (2 listed)
- Patients with primary renal diseases or renal impairment (eGFR < 90), or medical conditions such as diabetes, or systemic diseases or medications that alter calcium metabolism
- Patients with known bladder voiding problems
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 |
|---|---|---|
| Sodium and Potassium CitrateSodium and potassium citrate levels will be altered in diet and renal mineral handling will be measured as compared to placebo. | Dietary supplement | High Sodium plus Potassium Citrate, Low Sodium plus Potassium Citrate |
| PlaceboSodium without Potassium Citrate | Dietary supplement | High Sodium plus placebo, Low Sodium plus placebo |
Primary outcome
Urine Calcium levels
Time frame: 10 days
Amount of calcium in the urine will be measured
Results and safety
The study was stopped early (reason given: Study closed due to IRB expiration. A new protocol (IRB22-1817) was submitted to continue the research.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sodium and Potassium Citrate in people with Kidney Stone, run by University of Chicago 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 3 inclusion and 2 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: stopped early, as of the sponsor's last update on 22 Apr 2025. 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. Some participants in this study may receive a placebo. 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 stopped early (reason given: Study closed due to IRB expiration. A new protocol (IRB22-1817) was submitted to continue the research.). Results are not available in the source record.
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?
Urine Calcium levels (time frame: 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Apr 2025.