Comparing Alkalinizing Agents Efficacy on Stone Risk in Patients on a Metabolically Controlled Diet

The University of Texas System (UT)

Status and phase: Not yet enrolling; Early Phase 1

Conditions: Kidney Stone

Treatments: Dietary Supplement: Litholyte; Drug: Sodium bicarbonate; Drug: Potassium citrate; Drug: Potassium Bicarbonate; Dietary Supplement: Crystal Lite

Study type: Interventional

Funder types: Other

Identifiers

NCT04651088

STU-2020-0613

Details and patient eligibility

About

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.

Full 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.

Enrollment: 15 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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15 participants in 6 patient groups, including a placebo group

Metabolic diet

Placebo Comparator group

Description:

Controlled metabolic diet arm.

Treatment:

Dietary Supplement: Crystal Lite

Drug: Potassium Bicarbonate

Drug: Potassium citrate

Drug: Sodium bicarbonate

Dietary Supplement: Litholyte

Potassium citrate

Active Comparator group

Treatment:

Dietary Supplement: Crystal Lite

Drug: Potassium Bicarbonate

Drug: Potassium citrate

Drug: Sodium bicarbonate

Dietary Supplement: Litholyte

Sodium Bicarbonate

Active Comparator group

Treatment:

Dietary Supplement: Crystal Lite

Drug: Potassium Bicarbonate

Drug: Potassium citrate

Drug: Sodium bicarbonate

Dietary Supplement: Litholyte

Litholyte arm

Active Comparator group

Treatment:

Dietary Supplement: Crystal Lite

Drug: Potassium Bicarbonate

Drug: Potassium citrate

Drug: Sodium bicarbonate

Dietary Supplement: Litholyte

Crystal Lite

Active Comparator group

Treatment:

Dietary Supplement: Crystal Lite

Drug: Potassium Bicarbonate

Drug: Potassium citrate

Drug: Sodium bicarbonate

Dietary Supplement: Litholyte

Potassium Bicarbonate

Active Comparator group

Treatment:

Dietary Supplement: Crystal Lite

Drug: Potassium Bicarbonate

Drug: Potassium citrate

Drug: Sodium bicarbonate

Dietary Supplement: Litholyte