Hydroxycitrate: A Novel Therapy for Calcium Phosphate Urinary Stones
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: OHCit- standard dose, Potassium Citrate, Placebo, OHCit- low dose.
- Who it may be relevant to
- Registry conditions: Calcium Phosphate Kidney Stones. Basic parameters: 21 years — 99 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- 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.
Primary outcome measures
- Formation product (FP) for Calcium Phosphate [Time frame: After 1 week of treatment]
Secondary outcome measures (2)
- Crystal growth of Calcium Phosphate [Time frame: After 1 week of treatment]
- Calcium Phosphate supersaturation [Time frame: After 1 week of treatment]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Quadruple blind
- Primary purpose
- Prevention
Study locations
United States · 1 center
- UT Southwestern Medical Center — Dallas
Identifiers
NCT: NCT06003348 · 2023-0339