University of Texas Southwestern Medical Center
Dallas, Texas, 75390, United States
NCT Number: NCT04651088
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.
Trial opening soon.
Get Notified18 year–90 year
All sexes
Interventional
Early Phase 1
Dallas, Texas, 75390, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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
Time frame: Change from baseline (Day 4) to initial start on treatment (Day 5)
Total urine volume
Time frame: Change from baseline (Day 4) to end of study (day 12)
Total urine volume
Time frame: Change from baseline (Day 4) to initial start on treatment (Day 5)
Urine creatinine
Time frame: Change from baseline (Day 4) to end of study (day 12)
Urine creatinine
Time frame: Change from baseline (Day 4) to initial start on treatment (Day 5)
urine calcium
Time frame: Change from baseline (Day 4) to end of study (day 12)
urine calcium
Time frame: Change from baseline (Day 4) to initial start on treatment (Day 5)
Urine potassium
Time frame: Change from baseline (Day 4) to end of study (day 12)
Urine potassium
Time frame: Change from baseline (Day 4) to initial start on treatment (Day 5)
Urine sodium
Time frame: Change from baseline (Day 4) to end of study (day 12)
Urine sodium
Time frame: Change from baseline (Day 4) to initial start on treatment (Day 5)
Urine citrate
Time frame: Change from baseline (Day 4) to end of study (day 12)
Urine citrate
Time frame: Change from baseline (Day 4) to initial start on treatment (Day 5)
Urine uric acid
Time frame: Change from baseline (Day 4) to end of study (day 12)
Urine Uric Acid
Time frame: Change from baseline (Day 4) to initial start on treatment (Day 5)
Urine oxalate
Time frame: Change from baseline (Day 4) to end of study (day 12)
Urine oxalate
Time frame: Change from baseline (Day 4) to initial start on treatment (Day 5)
Urine magnesium
Time frame: Change from baseline (Day 4) to end of study (day 12)
Urine magnesium
Time frame: Change from baseline (Day 4) to initial start on treatment (Day 5)
Urine ammonia
Time frame: Change from baseline (Day 4) to end of study (day 12)
Urine ammonia
Time frame: Change from baseline (Day 4) to initial start on treatment (Day 5)
Overal Urine pH from 24h urine sample.
Time frame: Change from baseline (Day 4) to end of study (day 12)
Overal Urine pH from 24h urine sample.
Time frame: Change from baseline (Day 4) to initial start on treatment (Day 5)
Urine phosphorus
Time frame: Change from baseline (Day 4) to end of study (day 12)
Urine phosphorus
Time frame: Change from baseline (Day 4) to initial start on treatment (Day 5)
Urine sulfate
Time frame: Change from baseline (Day 4) to end of study (day 12)
Urine sulfate
Time frame: At the end of study approximately 10 weeks after start of study.
Patient's adherence to medication for duration of study.
Time frame: At the end of study approximately 10 weeks after start of study.
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 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 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.
Contact information is provided by the study sponsor or research team.
Ashley Gonzalez, MD
CONTACT
Brett A Johnson, MD
CONTACT
University of Texas Southwestern Medical Center
Other
Evaluation of Multiple Alkalinizing Agents on Urinary Stone Risk Parameters in Stone and Non-stone Formers on a Metabolically Controlled Diet
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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