Potassium Citrate and Crystal Light Lemonade

Kidney Stone Clinical Trial

Official title:

Assessing the Effects of a Commercial Lemonade Beverage and Potassium Citrate on Urinary Stone Risk Factors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05389995
• Other study ID #: STU00216084
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2022
• Est. completion date: March 31, 2025

Study information

• Verified date: June 2024
• Source: Northwestern University
• Contact: Alyssa McDonald
• Phone: 3126958146
• Email: alyssa.mcdonald[@]northwestern.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: March 31, 2025
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Kidney Calculi
• Kidney Stone

Intervention

Drug:
• Potassium citrate
7 days potassium citrate followed by 24 hour urine collection
• Crystal light
7 days crystal light followed by 24 hour urine collection
• Potassium citrate + crystal light
7 days potassium citrate + crystal light followed by 24 hour urine collection

Locations

Country	Name	City	State
United States	Northwestern University	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	urine citrate levels	24 hour urine collection	Day 7 of week 1
Primary	urine citrate levels	24 hour urine collection	Day 7 of week 3
Primary	urine citrate levels	24 hour urine collection	Day 7 of week 5