NCT06003348

Hydroxycitrate: A Novel Therapy for Calcium Phosphate Urinary Stones

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: University of Texas Southwestern Medical Center · Academic / Other
• Sex: All
• Age: 21 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

This study tests whether hydroxycitrate, a molecule closely related to citrate, can reduce calcium phosphate stone recurrence.

Detailed description

In this double-blind, placebo-controlled, randomized, crossover study, each participant will undergo 4 phases of study, with the order randomized by a blocked randomization scheme. The 4 phases will be Placebo, Super CitriMax (hydroxycitrate) OHCit low dose, OHCit standard dose, or Potassium Citrate. Randomization will be stratified based on sex, concomitant thiazide use, and concomitant alkali use. Each phase will be 1 week in duration, during which subjects will take assigned study medications. A minimum 1-week washout period will be imposed between phases. During the first 2 days of each phase, subjects will be instructed to adhere to a prescribed diet. On the last 5 days of each phase, subjects will be kept on a constant metabolic diet. Use of metabolic diet is essential to eliminate confounders that could occur from changes in dietary intake across phases. During the final two study days (days 6-7), two 24-hr urines will be collected for urine biochemistry and crystallization studies. Fasting blood will be obtained at the end of the last urine collection. Study Medications: Subjects will receive three tablets twice daily during each phase. These will consist of either placebo, Potassium Citrate (KCit), or Super CitriMax (OHCit). Study tablets will be prepared by a compounding pharmacy, with placebo tablets similar in appearance and size to the active medication tablets.

Conditions

• Calcium Phosphate Kidney Stones

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	OHCit- standard dose	Hydroxycitrate Over-the-counter supplement, not FDA approved or regulated.
DRUG	Potassium Citrate	10 mEq Extended-release tablets for oral use
DRUG	Placebo	Placebo
DIETARY_SUPPLEMENT	OHCit- low dose	Hydroxycitrate Over-the-counter supplement, not FDA approved or regulated.

Timeline

• Start date: 2023-12-13
• Primary completion: 2028-05-31
• Completion: 2028-08-31
• First posted: 2023-08-21
• Last updated: 2025-04-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study