Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Dietary Source of Potassium Citrate to Resolve Hypocitraturia and Aciduria in Patients With Kidney Stones

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03984409
Recruitment Status : Recruiting
First Posted : June 13, 2019
Last Update Posted : June 13, 2019
Sponsor:
Information provided by (Responsible Party):
Tim Large, Indiana University

Brief Summary:
Patients with nephrolithiasis and evidence of hypocitraturia or aciduria who would otherwise be started on potassium citrate, can achieve similar urine alkalization with 500-1000 mL of daily low calorie orange juice consumption.

Condition or disease Intervention/treatment Phase
Kidney Calculi Dietary Supplement: Kroger low calorie orange juice beverage Not Applicable

Detailed Description:

Potassium Citrate (kcit) has long been utilized by physicians to combat stone formation in patients with hypocitraturia or aciduria. The most common obstacle to patient compliance with this medication has historically been dosing frequency, pill size, dyspepsia, and its familiar unpleasant taste. However, rampant increases in drug pricing by pharmaceutical companies, that have achieved market control of the drug supply, are triggering non-compliance in the subset of stone patients who depend on potassium citrate therapy to prevent stone recurrence.

Previous research has shown that certain commercially available beverages contain alkali citrate, of which orange juice (OJ) has the highest reported concentrations of potassium citrate based on ion chromatography. Unfortunately, the high sugar content of orange juice excludes its potential use as a dietary alternative to prescription potassium citrate. Recently, major beverage companies (Pepsi, Coca Cola) have release low calorie beverages with equivalent citrate content but with 50% less sugar. In early 2018 the investigaotrs performed ion-chromatography on various consumer beverages and validated that low calorie orange juice provided equivalent alkali citrate and malate to standard orange juice. The ion-chromatography also showed that the total amount of alkali/liter was greater in low calorie orange juice compared to crystal light lemon flavored. Currently, crystal light lemon is recommended as the next best option to water for recurrent stone formers with low urine volume production and hypocitraturia or aciduria (https://kidneystones.uchicago.edu/price-of-potassium-citrate/). However, there is a concern that the citrate within lemon based beverages is predominantly in an acidic form and thus has less potential to provide clinically affective levels of alkali despite a favorable alkali profile on ion chromatography.

Since low calorie orange juice was identified as a potential sources for citrate and alkali, the investigators wanted to show that consumption of the beverages resulted in desirable changes in urinary pH and citrate levels without negatively affecting patient well-being. Ten (10) volunteers drank standardized quantities of water, crystal light lemon juice, and two low calorie orange juices. After 7 days of beverage consumption the participants performed a 24 hour urine collection which was performed by an independent laboratory. The participants also maintained a diary of dietary (both food and drink) intake in addition to the trial beverages. The data from the study is very promising with desired changes in urinary pH and citrate levels with consumption of the low calorie orange juice. Minimal side effects were noted from consuming the low calorie orange juice except with Tropicana50 based on journals. It was determined that the artificial sweetener in TRP50 was the causative agent for GI symptoms and headaches. The preferred brand based on volunteer diaries was a generic brand by Kroger® low calorie orange beverage.

Our data suggests that low calorie orange juice has the potential to improve compliance rates with alkali therapy amongst recurrent stone formers. Stone prevention is key to reducing long-term sequelae of repeat surgical intervention such as iatrogenic genitourinary strictures, infections, and end organ damage. Additionally, there is a large cost savings potential with stone prevention by reducing hospital stays, surgical procedures, and missed work days due to stone disease. While daily low calorie orange juice may not completely supplant prescription potassium citrate therapy, it may be a favorable adjunct to reduce cost associated with potassium citrate and increase compliance rates by reducing the dose required to clinically relevant alkalization of the urine. Our hypothesis, is that patients with nephrolithiasis and evidence of hypocitraturia or aciduria who would otherwise be started on potassium citrate, can achieve similar urine alkalization with 500-1000 mL of daily low calorie orange juice consumption.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:

Group 1 kcit x 7 days ↓ Litholink on day 7

↓ off therapy x 7 days

↓ OJ 500 ML + 1.5L water /day x 7 days

↓ Litholink on day 7

↓ OJ 1000 ML + 1L water /day x 7 days

↓ Litholink on day 7 Return to kcit therapy

Group 2 OJ 500 ML + 1.5L water /day x 7 days ↓ Litholink on day 7

↓ OJ 1000 ML + 1L water /day x 7 days

↓ Litholink on day 7

↓ off therapy x 7 days

↓ kcit x 7 days

↓ Litholink on day 7 Continue on kcit therapy

Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Dietary Source of Potassium Citrate to Resolve Hypocitraturia and Aciduria in Patients With a History of Nephrolithiasis
Actual Study Start Date : June 1, 2019
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : May 31, 2020


Arm Intervention/treatment
Active Comparator: Group 1
Potassium citrate x 7days Off therapy x 7 days 500 mL low calorie orange juice beverage x 7 days 1000 mL low calorie orange juice beverage x 7 days Return to potassium citrate therapy Litholink urine collection to be performed after each 7 days treatment
Dietary Supplement: Kroger low calorie orange juice beverage
Kroger low calorie orange juice beverage will be consumed for 7 days followed by a 24 hour urine collection with Litholink to see if urine alkalization similar to potassium citrate can be achieved
Other Name: potassium citrate

Active Comparator: Group 2
500 mL low calorie orange juice beverage x 7 days 1000 mL low calorie orange juice beverage x 7 days Off therapy x 7 days Potassium citrate x 7days Continue on potassium citrate therapy Litholink urine collection to be performed after each 7 days treatment
Dietary Supplement: Kroger low calorie orange juice beverage
Kroger low calorie orange juice beverage will be consumed for 7 days followed by a 24 hour urine collection with Litholink to see if urine alkalization similar to potassium citrate can be achieved
Other Name: potassium citrate




Primary Outcome Measures :
  1. Urine alkalization from Kroger low calorie orange juice beverage [ Time Frame: 9 weeks from enrollment ]
    The primary endpoint of interest will be the changes in urinary citrate while consuming Kroger low calorie orange juice beverage compared to potassium citrate therapy.

  2. Urine alkalization from Kroger low calorie orange juice beverage [ Time Frame: 9 weeks from enrollment ]
    The primary endpoint of interest will be the changes in urinary pH while consuming Kroger low calorie orange juice beverage compared to potassium citrate therapy.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • • Between 18 and 75 year of age.

    • History of kidney stone disease with available stone analysis
    • Evidence of aciduria or hypocitraturia on 24 hour urinalysis (24 hr citrate male <450 mg/day female <550 mg/day) or aciduria (urine pH < 5.8)
    • Ability to drink Kroger low calorie orange juice beverage
    • If subject with history of diabetes mellitus, must have HgA1c < 7.5 and willing to check daily blood sugars.

Exclusion Criteria:

  • • Less than 18 or older than 75 years of age

    • Allergies to low calorie orange juice, including intolerance because of side effects including (but not limited to): gastrointestinal symptoms, headaches, weight gain, unable to drink because of taste.
    • Poorly controlled diabetic (HgA1c >7.5)
    • No evidence of hypocitraturia or aciduria on 24 hour urinalysis
    • Unable to afford potassium citrate therapy or tolerate medication because of side effects.
    • Unwilling to perform 3 24-hour urine collections

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03984409


Contacts
Layout table for location contacts
Contact: Tim Large, MD 3179623700 timlarge@iupui.edu
Contact: Christa Stoughton 3179620870 cstoughton@iuhealth.org

Locations
Layout table for location information
United States, Indiana
Indiana University Health Methodist Hospital Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Christa Stoughton    317-962-0870    cstoughton@iuhealth.rog   
Indiana University Health Physicians Urology Not yet recruiting
Indianapolis, Indiana, United States, 46202
Contact: Tim Large, MD    317-962-3700    timlarge@iupui.edu   
Contact: Christa E Stoughton    3179620870    cstoughton@iuhealth.org   
Sponsors and Collaborators
Indiana University
Investigators
Layout table for investigator information
Principal Investigator: Tim Large, MD Indiana University Health

Layout table for additonal information
Responsible Party: Tim Large, Principal Investigator, Indiana University
ClinicalTrials.gov Identifier: NCT03984409     History of Changes
Other Study ID Numbers: 1903221743
First Posted: June 13, 2019    Key Record Dates
Last Update Posted: June 13, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Calculi
Kidney Calculi
Nephrolithiasis
Pathological Conditions, Anatomical
Kidney Diseases
Urologic Diseases
Urolithiasis
Urinary Calculi
Citric Acid
Sodium Citrate
Potassium Citrate
Anticoagulants
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Expectorants
Respiratory System Agents