Potassium Citrate and Crystal Light Lemonade

January 16, 2026 updated by: Amy Krambeck, Northwestern University

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Men and women between age 18-80 years
  2. Willing to follow experimental protocol
  3. Willing to complete 24-hour urine collections (three total)
  4. Willing to sign the informed consent form

  5. 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

Exclusion Criteria:

  1. Patients with severe hypocitraturia < 200 mg/day (men or women)
  2. 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
  3. Patients with distal renal tubular acidosis or medication induced RTA (e.g. carbonic anhydrase inhibitor, topiramate)
  4. Members of vulnerable patient populations
  5. Allergies to ingredients in crystal light
  6. Patients lacking decisional capacity

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Potassium citrate
Drug: Potassium citrate
7 days potassium citrate followed by 24 hour urine collection
Active Comparator: Crystal light
Drug: Crystal light
7 days crystal light followed by 24 hour urine collection
Active Comparator: Crystal light + potassium citrate
Drug: Potassium citrate + crystal light
7 days potassium citrate + crystal light followed by 24 hour urine collection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
urine citrate levels
Time Frame: Day 7 of week 1
24 hour urine collection
Day 7 of week 1
urine citrate levels
Time Frame: Day 7 of week 3
24 hour urine collection
Day 7 of week 3
urine citrate levels
Time Frame: Day 7 of week 5
24 hour urine collection
Day 7 of week 5

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwestern University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2022

Primary Completion (Actual)

April 1, 2025

Study Completion (Estimated)

January 31, 2027

Study Registration Dates

First Submitted

May 17, 2022

First Submitted That Met QC Criteria

May 21, 2022

First Posted (Actual)

May 25, 2022

Study Record Updates

Last Update Posted (Actual)

January 21, 2026

Last Update Submitted That Met QC Criteria

January 16, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STU00216084

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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