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Potassium Citrate and Crystal Light Lemonade

Primary Purpose

Kidney Stone

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Potassium citrate
Crystal light
Potassium citrate + crystal light
Sponsored by
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Kidney Stone

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Northwestern UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Potassium citrate

Crystal light

Crystal light + potassium citrate

Arm Description

Outcomes

Primary Outcome Measures

urine citrate levels
24 hour urine collection
urine citrate levels
24 hour urine collection
urine citrate levels
24 hour urine collection

Secondary Outcome Measures

Full Information

First Posted
May 17, 2022
Last Updated
September 11, 2023
Sponsor
Northwestern University
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1. Study Identification

Unique Protocol Identification Number
NCT05389995
Brief Title
Potassium Citrate and Crystal Light Lemonade
Official Title
Assessing the Effects of a Commercial Lemonade Beverage and Potassium Citrate on Urinary Stone Risk Factors
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2022 (Actual)
Primary Completion Date
June 1, 2023 (Actual)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University

4. Oversight

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.
Yes
Data Monitoring Committee
No

5. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Stone

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Potassium citrate
Arm Type
Active Comparator
Arm Title
Crystal light
Arm Type
Active Comparator
Arm Title
Crystal light + potassium citrate
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Potassium citrate
Intervention Description
7 days potassium citrate followed by 24 hour urine collection
Intervention Type
Drug
Intervention Name(s)
Crystal light
Intervention Description
7 days crystal light followed by 24 hour urine collection
Intervention Type
Drug
Intervention Name(s)
Potassium citrate + crystal light
Intervention Description
7 days potassium citrate + crystal light followed by 24 hour urine collection
Primary Outcome Measure Information:
Title
urine citrate levels
Description
24 hour urine collection
Time Frame
Day 7 of week 1
Title
urine citrate levels
Description
24 hour urine collection
Time Frame
Day 7 of week 3
Title
urine citrate levels
Description
24 hour urine collection
Time Frame
Day 7 of week 5

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Men and women between age 18-80 years Willing to follow experimental protocol Willing to complete 24-hour urine collections (three total) Willing to sign the informed consent form 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: Patients with severe hypocitraturia < 200 mg/day (men or women) 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 Patients with distal renal tubular acidosis or medication induced RTA (e.g. carbonic anhydrase inhibitor, topiramate) Members of vulnerable patient populations Allergies to ingredients in crystal light Patients lacking decisional capacity
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jessica Helon
Phone
3126958146
Email
jessica.helon@northwestern.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Matt Lee, MD
Phone
3129265564
Email
matt.lee1@northwestern.edu
Facility Information:
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jessica Helon
Email
jessica.helon@northwestern.edu

12. IPD Sharing Statement

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Potassium Citrate and Crystal Light Lemonade

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