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

Part of paid clinical trials in Dallas, Texas.

Sponsor
University of Texas Southwestern Medical Center
Study ID
NCT04651088
Phase
EARLY_PHASE1
Status
Not Yet Recruiting

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Conditions

  • Kidney Stone

Eligibility Criteria

Sex
ALL
Age
18 Years - 90 Years
Healthy Volunteers
Accepted

Interventions

  • Potassium citrate — DRUG
    Slow release potassium citrate UroCit-K. Participants will take 20mEq twice daily.
  • Sodium bicarbonate — DRUG
    650mg tabs. Take 3 tabs twice daily.
  • Litholyte — DIETARY_SUPPLEMENT
    One packet is taken with 170ml of water. Two packets daily.
  • Crystal Lite — DIETARY_SUPPLEMENT
    The classic lemonade contains 21.7mEq/liter of alkali Therefore, patients will take 2 litres daily to have the 40mEq of alkali daily needed.
  • Potassium Bicarbonate — DRUG
    20 mEq tablets, one tablet twice daily

Study Details

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.

Key Dates

Start date
Jul 1, 2026
Status verified
Feb 2026
Primary completion
Dec 31, 2026
Completion
Jul 31, 2027

Study Design

Enrollment
15 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Placebo Comparator: Metabolic diet
    Controlled metabolic diet arm.
  • Active Comparator: Potassium citrate
  • Active Comparator: Sodium Bicarbonate
  • Active Comparator: Litholyte arm
  • Active Comparator: Crystal Lite
  • Active Comparator: Potassium Bicarbonate

Primary Outcome Measure

24 hour urine volume [ Time Frame: Change from baseline (Day 4) to initial start on treatment (Day 5) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Texas Southwestern Medical CenterDallasTexas75390
Brett Johnson, MD
[email protected]
2146486853

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By research site
University of Texas Southwestern Medical Center· Dallas, TX

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