Potassium Citrate and Crystal Light Lemonade

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: Recruiting
• Conditions: Kidney Stone
• Intervention / Treatment: Drug: Potassium citrate; Drug: Crystal light; Drug: Potassium citrate + crystal light

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jessica Helon; Phone Number: 3126958146; Email: jessica.helon@northwestern.edu
• Study Contact Backup: Name: Matt Lee, MD; Phone Number: 3129265564; Email: matt.lee1@northwestern.edu

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Recruiting
      • Northwestern University
      • Contact: Jessica Helon; Email: jessica.helon@northwestern.edu

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

3

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	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

Collaborators and Investigators

• Sponsor: Northwestern University

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2022
• Primary Completion (Actual): June 1, 2023
• Study Completion (Estimated): March 31, 2024

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 (Estimated): February 13, 2024
• Last Update Submitted That Met QC Criteria: February 12, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Pathological Conditions, Anatomical; Urolithiasis; Urinary Calculi; Calculi; Nephrolithiasis; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Kidney Calculi; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Natriuretic Agents; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Dopamine Agents; Diuretics; Respiratory System Agents; Anticoagulants; Dopamine Uptake Inhibitors; Chelating Agents; Sequestering Agents; Central Nervous System Stimulants; Sympathomimetics; Adrenergic Uptake Inhibitors; Expectorants; Calcium Chelating Agents; Methamphetamine; Citric Acid; Sodium Citrate; Potassium Citrate
• 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