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.
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
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 group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | 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 Receives: Dietary Supplement: Kroger low calorie orange juice beverage |
| Group 2 | Active comparator | 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 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.
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
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.
- First posted13 Jun 2019
- Study start1 Jun 2019
- Primary completion31 Aug 2020
- Study completion1 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney CalculiStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tim Large, Indiana University
- Investigators
- Tim Large, MD, Principal investigator, Indiana University Health
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
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Dietary Source of Potassium Citrate to Resolve Hypocitraturia and Aciduria in Patients With a History of Nephrolithiasis
- ClinicalTrials.gov ID
- NCT03984409
- Acronym / sponsor ID
- 1903221743
- Conditions
- Kidney Calculi
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 31 Aug 2020 (actual)
- Study completion
- 1 Nov 2020 (actual)
- First posted
- 13 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Dietary Supplement: Kroger low calorie orange juice beveragePotassium 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 |
| Group 2 | Active comparator | Dietary Supplement: Kroger low calorie orange juice beverage500 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 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- • Between 18 and 75 year of age.
Key exclusion criteria (6 listed)
- • Less than 18 or older than 75 years of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Kroger low calorie orange juice beverageAlso: potassium citrateKroger 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 | Dietary supplement | Group 1, Group 2 |
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tim Large, MD principal investigator
Indiana University Health
2 sites in 1 country: see every site and its status.
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.