Potassium Citrate and Crystal Light Lemonade
Assessing the Effects of a Commercial Lemonade Beverage and Potassium Citrate on Urinary Stone Risk Factors
1 other identifier
interventional
10
1 country
1
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Aug 2022
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 17, 2022
CompletedFirst Posted
Study publicly available on registry
May 25, 2022
CompletedStudy Start
First participant enrolled
August 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2027
ExpectedJanuary 21, 2026
January 1, 2026
2.7 years
May 17, 2022
January 16, 2026
Conditions
Outcome Measures
Primary Outcomes (3)
urine citrate levels
24 hour urine collection
Day 7 of week 1
urine citrate levels
24 hour urine collection
Day 7 of week 3
urine citrate levels
24 hour urine collection
Day 7 of week 5
Study Arms (3)
Potassium citrate
ACTIVE COMPARATORCrystal light
ACTIVE COMPARATORCrystal light + potassium citrate
ACTIVE COMPARATORInterventions
7 days potassium citrate + crystal light followed by 24 hour urine collection
Eligibility Criteria
You may qualify if:
- 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
- a. hypocitraturia OR aciduria i. Hypocitraturics must meet definition of \< 450 mg/day for men \< 550 mg/day for women.
- b. Low urine pH must be less than 5.6 c. potassium, BUN, creatinine, eGFR and hemoglobin A1c within normal limits
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Northwestern University
Chicago, Illinois, 60611, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of the Endourology/Stone Division
Study Record Dates
First Submitted
May 17, 2022
First Posted
May 25, 2022
Study Start
August 1, 2022
Primary Completion
April 1, 2025
Study Completion (Estimated)
January 31, 2027
Last Updated
January 21, 2026
Record last verified: 2026-01