Kidney StoneNCT05389995
Potassium Citrate and Crystal Light Lemonade
A study testing Potassium citrate, Crystal light and Potassium citrate + crystal light in people with Kidney Stone, run by Northwestern University at 1 site in United States.
Trial summary
To define the effect of crystal light, potassium citrate, or both on urinary stone risk factors in patients with a history of stone and hypocitraturia/low pH Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Kidney Stone
- What is being tested?
- Potassium citrate, Crystal light and Potassium citrate + crystal light
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2022to 31 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women between age 18-80 years
- Willing to follow experimental protocol
- Willing to complete 24-hour urine collections (three total)
- Willing to sign the informed consent form
- Completed Litholink Collection with blood work with results
- hypocitraturia OR aciduria i. Hypocitraturics must meet definition of < 450 mg/day for men < 550 mg/day for women.
- Low urine pH must be less than 5.6 c. potassium, BUN, creatinine, eGFR and hemoglobin A1c within normal limits
Who cannot join
- Patients with severe hypocitraturia < 200 mg/day (men or women)
- Patients with hyperkalemia, uncontrolled diabetes, chronic kidney disease, adrenal insufficiency, delayed gastric emptying (or drug induced delayed gastric emptying), peptic ulcer disease, or active UTI
- Patients with distal renal tubular acidosis or medication induced RTA (e.g. carbonic anhydrase inhibitor, topiramate)
- Members of vulnerable patient populations
- Allergies to ingredients in crystal light
- Patients lacking decisional capacity
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessing the Effects of a Commercial Lemonade Beverage and Potassium Citrate on Urinary Stone Risk Factors
To define the effect of crystal light, potassium citrate, or both on urinary stone risk factors in patients with a history of stone and hypocitraturia/low pH
- Conditions
- Kidney Stone
- Being tested
- Potassium citrate, Crystal light, Potassium citrate + crystal light
- Medical subject headings
- Kidney Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Potassium citrateDrug
7 days potassium citrate followed by 24 hour urine collection
Crystal lightDrug
7 days crystal light followed by 24 hour urine collection
Potassium citrate + crystal lightDrug
7 days potassium citrate + crystal light followed by 24 hour urine collection
| Study group | Role | What they receive |
|---|---|---|
| Potassium citrate | Active comparator | Not described Receives: Drug: Potassium citrate |
| Crystal light | Active comparator | Not described Receives: Drug: Crystal light |
| Crystal light + potassium citrate | Active comparator | Not described Receives: Drug: Potassium citrate + crystal light |
What is being measured
The primary outcome is the main question the study is designed to answer.
urine citrate levels
24 hour urine collection
Measured: Day 7 of week 1
urine citrate levels
24 hour urine collection
Measured: Day 7 of week 3
urine citrate levels
24 hour urine collection
Measured: Day 7 of week 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2022
- Study start1 Aug 2022
- Primary completion1 Apr 2025
- Study completion31 Jan 2027 (estimated)
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 StoneStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amy Krambeck, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05389995
- Sponsor's protocol ID
- STU00216084
- Status last verified
- Jan 2026
- First submitted
- 17 May 2022
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Guo JN, Patel A, Tsai KP, Khondakar N, Krambeck AE, Lee MS. Effects of a commercial lemonade beverage, potassium citrate, and combination therapy on urinary stone risk parameters in hypocitraturic stone formers: a randomized crossover trial. Transl Androl Urol. 2026 Aug 31;15(8):267. doi: 10.21037/tau-2026-0345. Epub 2026 Aug 27.
PubMed 42729157
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Effects of a Commercial Lemonade Beverage and Potassium Citrate on Urinary Stone Risk Factors
- ClinicalTrials.gov ID
- NCT05389995
- Acronym / sponsor ID
- STU00216084
- Conditions
- Kidney Stone
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 1 Apr 2025 (actual)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 25 May 2022 (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.
To define the effect of crystal light, potassium citrate, or both on urinary stone risk factors in patients with a history of stone and hypocitraturia/low pH
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Potassium citrate | Active comparator | Drug: Potassium citrate |
| Crystal light | Active comparator | Drug: Crystal light |
| Crystal light + potassium citrate | Active comparator | Drug: Potassium citrate + crystal light |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Men and women between age 18-80 years
- Willing to follow experimental protocol
- Willing to complete 24-hour urine collections (three total)
- Willing to sign the informed consent form
- Completed Litholink Collection with blood work with results
Key exclusion criteria (6 listed)
- Patients with severe hypocitraturia < 200 mg/day (men or women)
- Patients with hyperkalemia, uncontrolled diabetes, chronic kidney disease, adrenal insufficiency, delayed gastric emptying (or drug induced delayed gastric emptying), peptic ulcer disease, or active UTI
- Patients with distal renal tubular acidosis or medication induced RTA (e.g. carbonic anhydrase inhibitor, topiramate)
- Members of vulnerable patient populations
- Allergies to ingredients in crystal light
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 citrate7 days potassium citrate followed by 24 hour urine collection | Drug | Potassium citrate |
| Crystal light7 days crystal light followed by 24 hour urine collection | Drug | Crystal light |
| Potassium citrate + crystal light7 days potassium citrate + crystal light followed by 24 hour urine collection | Drug | Crystal light + potassium citrate |
Primary outcome
urine citrate levels
Time frame: Day 7 of week 1
24 hour urine collection
urine citrate levels
Time frame: Day 7 of week 3
24 hour urine collection
urine citrate levels
Time frame: Day 7 of week 5
24 hour urine collection
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
- Derived from this study: PubMed 42729157Guo JN, Patel A, Tsai KP, Khondakar N, Krambeck AE, Lee MS. Effects of a commercial lemonade beverage, potassium citrate, and combination therapy on urinary stone risk parameters in hypocitraturic stone formers: a randomized crossover trial. Transl Androl Urol. 2026 Aug 31;15(8):267. doi: 10.21037/tau-2026-0345. Epub 2026 Aug 27.
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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 Potassium citrate, Crystal light and Potassium citrate + crystal light in people with Kidney Stone, run by Northwestern University 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 7 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 21 Jan 2026. 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?
This study is still under way. Results are not available in the source record yet.
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 citrate levels (time frame: Day 7 of week 1). The study lists 3 primary outcomes in all. 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 NCT05389995, 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 21 Jan 2026.