Hydroxycitrate: A Novel Therapy for Calcium Phosphate Urinary Stones
University of Texas Southwestern Medical Center
Summary
This study tests whether hydroxycitrate, a molecule closely related to citrate, can reduce calcium phosphate stone recurrence.
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 p…
Eligibility
- Age range
- 21–99 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: \- Calcium Phosphate stone formers Exclusion Criteria: * History of recurrent urinary tract infections * Chronic diarrhea * Estimated Glomerular Filtration Rate (eGFR) \< 45 ml/min/1.73 m2 * History of primary hyperparathyroidism * Hypokalemia * Hyperkalemia * Pregnancy
Interventions
- Dietary SupplementOHCit- standard dose
Hydroxycitrate Over-the-counter supplement, not FDA approved or regulated.
- DrugPotassium Citrate
10 mEq Extended-release tablets for oral use
- DrugPlacebo
Placebo
- Dietary SupplementOHCit- low dose
Hydroxycitrate Over-the-counter supplement, not FDA approved or regulated.
Location
- UT Southwestern Medical CenterDallas, Texas