A Dietary Source of Potassium Citrate to Resolve Hypocitraturia and Aciduria in Patients With Kidney Stones
Condition: Kidney Calculi
MeSH terms: Kidney Calculi; Nephrolithiasis; Calculi
Study type: Interventional

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.
    

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.
    

Intervention name(s): Kroger low calorie orange juice beverage
Intervention type(s): Dietary Supplement
Intervention description(s): 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 intervention name(s): potassium citrate
Intervention MeSH terms: Potassium Citrate
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