Ignite Creation Date:
2024-05-06 @ 3:30 PM
Last Modification Date:
2024-10-26 @ 1:50 PM
Study NCT ID:
NCT04651088
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-01
First Post:
2020-11-04
Brief Title:
Comparing Alkalinizing Agents Efficacy on Stone Risk in Patients on a Metabolically Controlled Diet
Sponsor:
University of Texas Southwestern Medical Center
Organization:
University of Texas Southwestern Medical Center
Study Overview
Official Title:
Evaluation of Multiple Alkalinizing Agents on Urinary Stone Risk Parameters in Stone and Non-stone Formers on a Metabolically Controlled Diet
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 55 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 formation56
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 15day 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
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 55 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 formation56
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 15day 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None