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Kidney CalculiNCT03984409

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

A study testing Kroger low calorie orange juice beverage in people with Kidney Calculi, run by Indiana University at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Kidney Calculi
What is being tested?
Kroger low calorie orange juice beverage
Could I receive a placebo?
No, everyone receives an active treatment
How many people
22 participants
Where
2 sitesUnited States
Study dates
1 Jun 2019to 1 Nov 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • • 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.

Who cannot join

  • • 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

Trial locations and contacts

2 sites in 1 country.

United States2 sites
  • Indiana University Health Methodist Hospital

    Indianapolis, Indiana, 46202

  • Indiana University Health Physicians Urology

    Indianapolis, Indiana, 46202

Other trials in United States

About this study

Official title: A Dietary Source of Potassium Citrate to Resolve Hypocitraturia and Aciduria in Patients With a History of Nephrolithiasis

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.

Read the 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.

Conditions
Kidney Calculi
Being tested
Kroger low calorie orange juice beverage
Medical subject headings
Kidney Calculi

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Kroger low calorie orange juice beverageDietary supplement

    Also called potassium citrate

    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

Study groups in NCT03984409
Study groupRoleWhat they receive
Group 1Active comparatorPotassium 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
Receives: Dietary Supplement: Kroger low calorie orange juice beverage
Group 2Active comparator500 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
Receives: Dietary Supplement: Kroger low calorie orange juice beverage

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Urine alkalization from Kroger low calorie orange juice beverage

    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.

    Measured: 9 weeks from enrollment

  2. Urine alkalization from Kroger low calorie orange juice beverage

    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.

    Measured: 9 weeks from enrollment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jun 2019
  2. Study start1 Jun 2019
  3. Primary completion31 Aug 2020
  4. Study completion1 Nov 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Crossover
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)
Enrolment
22 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03984409
Sponsor's protocol ID
1903221743
Status last verified
Nov 2020
First submitted
22 May 2019
Last updated
19 Nov 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Kroger low calorie orange juice beverage in people with Kidney Calculi, run by Indiana University at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Urine alkalization from Kroger low calorie orange juice beverage (time frame: 9 weeks from enrollment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2020.

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