Potassium Citrate and Crystal Light Lemonade

NCT ID: NCT05389995

Last Updated: 2026-01-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-01

Study Completion Date

2027-01-31

Brief Summary

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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

Detailed Description

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Conditions

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Kidney Stone

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Potassium citrate

Group Type ACTIVE_COMPARATOR

Potassium citrate

Intervention Type DRUG

7 days potassium citrate followed by 24 hour urine collection

Crystal light

Group Type ACTIVE_COMPARATOR

Crystal light

Intervention Type DRUG

7 days crystal light followed by 24 hour urine collection

Crystal light + potassium citrate

Group Type ACTIVE_COMPARATOR

Potassium citrate + crystal light

Intervention Type DRUG

7 days potassium citrate + crystal light followed by 24 hour urine collection

Interventions

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Potassium citrate

7 days potassium citrate followed by 24 hour urine collection

Intervention Type DRUG

Crystal light

7 days crystal light followed by 24 hour urine collection

Intervention Type DRUG

Potassium citrate + crystal light

7 days potassium citrate + crystal light followed by 24 hour urine collection

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Northwestern University

OTHER

Sponsor Role lead

Responsible Party

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Amy Krambeck

Director of the Endourology/Stone Division

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Northwestern University

Chicago, Illinois, United States

Site Status

Countries

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United States

Other Identifiers

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STU00216084

Identifier Type: -

Identifier Source: org_study_id

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