Comparing Alkalinizing Agents Efficacy on Stone Risk in Patients on a Metabolically Controlled Diet
- Conditions
- Kidney Stone
- Interventions
- Dietary Supplement: LitholyteDietary Supplement: Crystal Lite
- Registration Number
- NCT04651088
- Lead Sponsor
- University of Texas Southwestern Medical Center
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 15
- Adults aged 18 and older.
- with or without a history of stone disease.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Potassium Bicarbonate Potassium Bicarbonate - Litholyte arm Litholyte - Metabolic diet Litholyte Controlled metabolic diet arm. Metabolic diet Crystal Lite Controlled metabolic diet arm. Potassium citrate Sodium bicarbonate - Sodium Bicarbonate Litholyte - Potassium citrate Crystal Lite - Sodium Bicarbonate Crystal Lite - Litholyte arm Crystal Lite - Potassium citrate Litholyte - Potassium Bicarbonate Litholyte - Crystal Lite Litholyte - Crystal Lite Sodium bicarbonate - Crystal Lite Crystal Lite - Potassium Bicarbonate Crystal Lite - Potassium Bicarbonate Potassium citrate - Potassium citrate Potassium citrate - Potassium citrate Potassium Bicarbonate - Metabolic diet Potassium citrate Controlled metabolic diet arm. Metabolic diet Sodium bicarbonate Controlled metabolic diet arm. Sodium Bicarbonate Potassium citrate - Sodium Bicarbonate Sodium bicarbonate - Sodium Bicarbonate Potassium Bicarbonate - Crystal Lite Potassium citrate - Litholyte arm Potassium citrate - Litholyte arm Sodium bicarbonate - Crystal Lite Potassium Bicarbonate - Potassium Bicarbonate Sodium bicarbonate - Litholyte arm Potassium Bicarbonate - Metabolic diet Potassium Bicarbonate Controlled metabolic diet arm.
- Primary Outcome Measures
Name Time Method 24 hour urine sodium Change from baseline (Day 4) to initial start on treatment (Day 5) Urine sodium
24 hours urine citrate Change from baseline (Day 4) to end of study (day 12) Urine citrate
24 Hour Urine pH Change from baseline (Day 4) to end of study (day 12) Overal Urine pH from 24h urine sample.
24 hour urine calcium Change from baseline (Day 4) to end of study (day 12) urine calcium
24 hours urine uric acid Change from baseline (Day 4) to end of study (day 12) Urine Uric Acid
24 hours urine oxalate Change from baseline (Day 4) to end of study (day 12) Urine oxalate
24 hours urine magnesium Change from baseline (Day 4) to end of study (day 12) Urine magnesium
24 hours urine ammonia Change from baseline (Day 4) to end of study (day 12) Urine ammonia
24 hour urine phosphorus Change from baseline (Day 4) to end of study (day 12) Urine phosphorus
24 hour urine creatinine Change from baseline (Day 4) to end of study (day 12) Urine creatinine
24 hour urine sulfate Change from baseline (Day 4) to end of study (day 12) Urine sulfate
24 hour urine volume Change from baseline (Day 4) to end of study (day 12) Total urine volume
24 hour urine potassium Change from baseline (Day 4) to end of study (day 12) Urine potassium
24 hours urine sodium Change from baseline (Day 4) to end of study (day 12) Urine sodium
- Secondary Outcome Measures
Name Time Method 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 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.
# 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.
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.
Trial Locations
- Locations (1)
University of Texas Southwestern Medical Center
🇺🇸Dallas, Texas, United States