The purpose of this study is to compare over the counter and alternative prescription urinary alkalinizing agents to slow release potassium citrate in their ability to modify urinary parameters associated with stone formation.
Kidney stones are a common medical problem, occurring in almost 10% of people in the United States1. Furthermore, 50% of patients will recur within 10 years2. Metabolic testing is advised in recurrent stone formers, as well as those considered high risk, to assess for a specific abnormality which may prompt intervention to prevent future stone formation. Non-surgical interventions include both dietary counselling, as well as pharmacotherapy. One of the most commonly prescribed class of pharmacotherapies is alkali therapy which can be used to both increase the urinary pH and raise the urine citrate levels. This is particularly useful as correction of very acidic urinary pH (\<5.5) can counteract uric acid crystallization thereby preventing or even dissolving uric acid stones3. Further, citrate has been shown to be a potent inhibitor of calcium stones by binding to the calcium directly4 and inhibiting crystal nucleation, thereby reducing calcium stone formation5,6. The most commonly utilized preparation of alkali therapy is potassium citrate which has been shown to prevent stone formation better than sodium citrate7. Unfortunately, some forms of potassium citrate (crystal packets) have become unavailable, and the slow release form of potassium citrate (UroCit-K) now exceeds $15/day in cost8. There have been multiple alternative alkali therapies that have been used in place of potassium citrate, including both medical foods and prescription medications, but with little evidence to support their use. A pilot study in order to quantify the metabolic effects of these agents and compare them to potassium citrate will be performed.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
15
Slow release potassium citrate UroCit-K. Participants will take 20mEq twice daily.
650mg tabs. Take 3 tabs twice daily.
One packet is taken with 170ml of water. Two packets daily.
University of Texas Southwestern Medical Center
Dallas, Texas, United States
24 hour urine volume
Total urine volume
Time frame: Change from baseline (Day 4) to initial start on treatment (Day 5)
24 hour urine volume
Total urine volume
Time frame: Change from baseline (Day 4) to end of study (day 12)
24 hour urine creatinine
Urine creatinine
Time frame: Change from baseline (Day 4) to initial start on treatment (Day 5)
24 hour urine creatinine
Urine creatinine
Time frame: Change from baseline (Day 4) to end of study (day 12)
24 hour urine calcium
urine calcium
Time frame: Change from baseline (Day 4) to initial start on treatment (Day 5)
24 hour urine calcium
urine calcium
Time frame: Change from baseline (Day 4) to end of study (day 12)
24 hour urine potassium
Urine potassium
Time frame: Change from baseline (Day 4) to initial start on treatment (Day 5)
24 hour urine potassium
Urine potassium
Time frame: Change from baseline (Day 4) to end of study (day 12)
24 hour urine sodium
Urine sodium
Time frame: Change from baseline (Day 4) to initial start on treatment (Day 5)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
The classic lemonade contains 21.7mEq/liter of alkali Therefore, patients will take 2 litres daily to have the 40mEq of alkali daily needed.
20 mEq tablets, one tablet twice daily
24 hours urine sodium
Urine sodium
Time frame: Change from baseline (Day 4) to end of study (day 12)
24 hours urine citrate
Urine citrate
Time frame: Change from baseline (Day 4) to initial start on treatment (Day 5)
24 hours urine citrate
Urine citrate
Time frame: Change from baseline (Day 4) to end of study (day 12)
24 hours urine uric acid
Urine uric acid
Time frame: Change from baseline (Day 4) to initial start on treatment (Day 5)
24 hours urine uric acid
Urine Uric Acid
Time frame: Change from baseline (Day 4) to end of study (day 12)
24 hours urine oxalate
Urine oxalate
Time frame: Change from baseline (Day 4) to initial start on treatment (Day 5)
24 hours urine oxalate
Urine oxalate
Time frame: Change from baseline (Day 4) to end of study (day 12)
24 hours urine magnesium
Urine magnesium
Time frame: Change from baseline (Day 4) to initial start on treatment (Day 5)
24 hours urine magnesium
Urine magnesium
Time frame: Change from baseline (Day 4) to end of study (day 12)
24 hours urine ammonia
Urine ammonia
Time frame: Change from baseline (Day 4) to initial start on treatment (Day 5)
24 hours urine ammonia
Urine ammonia
Time frame: Change from baseline (Day 4) to end of study (day 12)
24 Hour Urine pH
Overal Urine pH from 24h urine sample.
Time frame: Change from baseline (Day 4) to initial start on treatment (Day 5)
24 Hour Urine pH
Overal Urine pH from 24h urine sample.
Time frame: Change from baseline (Day 4) to end of study (day 12)
24 hour urine phosphorus
Urine phosphorus
Time frame: Change from baseline (Day 4) to initial start on treatment (Day 5)
24 hour urine phosphorus
Urine phosphorus
Time frame: Change from baseline (Day 4) to end of study (day 12)
24 hour urine sulfate
Urine sulfate
Time frame: Change from baseline (Day 4) to initial start on treatment (Day 5)
24 hour urine sulfate
Urine sulfate
Time frame: Change from baseline (Day 4) to end of study (day 12)
# of patient who adherence to 100% Medication
Patient's adherence to medication for duration of study.
Time frame: At the end of study approximately 10 weeks after start of study.
Total out of pocket cost
Calculate and compare treatment costs for the different interventions (in American dollars).
Time frame: At the end of study approximately 10 weeks after start of study.
Patient's Satisfaction Survey
Patient satisfaction survey, adapted from the Treatment Satisfaction Questionnaire for Medication-14. Patients are queried on their satisfaction, with 9 questions for each medication.
Time frame: At the end of study approximately 10 weeks after start of study.
Patient's GI Distress
Patient's GI distress symptom scale measures patients GI distress. There are 18 questions with descriptive answers ranging from "none", "mild", "moderate", "quite a lot" and "unbearable". There are no numerical scores, rather just descriptive scores. "None" means no GI distress, "unbearable" means that you are in a lot of distress from your GI symptoms.
Time frame: At the end of study approximately 10 weeks after start of study.