Potassium Citrate and Crystal Light Lemonade

• Sponsor: Northwestern University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05389995
• Collaborator: (none)
• Enrollment: 10
• Location: 1
• Arms: 3
• Anticipated Duration (Months): 17
• Patients Per Site Per Month: 0.6

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Kidney Stone	Drug: Potassium citrate; Drug: Crystal light; Drug: Potassium citrate + crystal light	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 10 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Assessing the Effects of a Commercial Lemonade Beverage and Potassium Citrate on Urinary Stone Risk Factors
• Anticipated Study Start Date: Aug 1, 2022
• Anticipated Primary Completion Date: Jun 1, 2023
• Anticipated Study Completion Date: Dec 31, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. urine citrate levels [Day 7 of week 1]

   24 hour urine collection

2. urine citrate levels [Day 7 of week 3]

   24 hour urine collection

3. urine citrate levels [Day 7 of week 5]

   24 hour urine collection

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

1. hypocitraturia OR aciduria i. Hypocitraturics must meet definition of < 450 mg/day for men < 550 mg/day for women.

2. 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Northwestern University	Chicago	Illinois	United States	60611

Sponsors and Collaborators

• Northwestern University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Amy Krambeck, Director of the Endourology/Stone Division, Northwestern University
• ClinicalTrials.gov Identifier: NCT05389995
• Other Study ID Numbers: STU00216084
• First Posted: May 25, 2022
• Last Update Posted: Jul 5, 2022
• Last Verified: Jul 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Kidney Calculi; Potassium Citrate; Methamphetamine; Citric Acid; Sodium Citrate

Study Results

No Results Posted as of Jul 5, 2022