Kidney Stone
Conditions
Brief summary
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.
Detailed description
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.
Interventions
Slow release potassium citrate UroCit-K. Participants will take 20mEq twice daily.
DRUGSodium bicarbonate
650mg tabs. Take 3 tabs twice daily.
DIETARY_SUPPLEMENTLitholyte
One packet is taken with 170ml of water. Two packets daily.
DIETARY_SUPPLEMENTCrystal Lite
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
Sponsors
University of Texas Southwestern Medical Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
Yes
Inclusion criteria
* Adults aged 18 and older. * with or without a history of stone disease.
Exclusion criteria
* They are unable to take any of the medications due to health reasons. * Participants are pregnant or nursing. * Participants are unable to adhere to the metabolic diet. * Participants had a prior adverse event from one or more of the medications.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 24 hour urine volume | Change from baseline (Day 4) to initial start on treatment (Day 5) | Total urine volume |
| 24 hour urine creatinine | Change from baseline (Day 4) to initial start on treatment (Day 5) | Urine creatinine |
| 24 hour urine calcium | Change from baseline (Day 4) to initial start on treatment (Day 5) | urine calcium |
| 24 hour urine potassium | Change from baseline (Day 4) to initial start on treatment (Day 5) | Urine potassium |
| 24 hour urine sodium | Change from baseline (Day 4) to initial start on treatment (Day 5) | Urine sodium |
| 24 hours urine sodium | Change from baseline (Day 4) to end of study (day 12) | Urine sodium |
| 24 hours urine citrate | Change from baseline (Day 4) to initial start on treatment (Day 5) | Urine citrate |
| 24 hours urine uric acid | Change from baseline (Day 4) to initial start on treatment (Day 5) | Urine uric acid |
| 24 hours urine oxalate | Change from baseline (Day 4) to initial start on treatment (Day 5) | Urine oxalate |
| 24 hours urine magnesium | Change from baseline (Day 4) to initial start on treatment (Day 5) | Urine magnesium |
| 24 hours urine ammonia | Change from baseline (Day 4) to initial start on treatment (Day 5) | Urine ammonia |
| 24 Hour Urine pH | Change from baseline (Day 4) to initial start on treatment (Day 5) | Overal Urine pH from 24h urine sample. |
| 24 hour urine phosphorus | Change from baseline (Day 4) to initial start on treatment (Day 5) | Urine phosphorus |
| 24 hour urine sulfate | Change from baseline (Day 4) to initial start on treatment (Day 5) | Urine sulfate |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| # of patient who adherence to 100% Medication | At the end of study approximately 10 weeks after start of study. | Patient's adherence to medication for duration of study. |
| Total out of pocket cost | At the end of study approximately 10 weeks after start of study. | Calculate and compare treatment costs for the different interventions (in American dollars). |
| Patient's Satisfaction Survey | 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. |
| Patient's GI Distress | 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. |
Countries
United States
Contacts
CONTACTBrett A Johnson, MD
CONTACTAshley Gonzalez, MD
Outcome results
None listed