Clinical trial NCT06003348: Hydroxycitrate: A Novel Therapy for Calcium Phosphate Urinary Stones
Official title: Hydroxycitrate: A Novel Therapy for Calcium Phosphate Urinary Stones
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Calcium Phosphate Kidney Stones
Keywords: Urolithiasis
Calcium phosphate
Citrate
Acid-base
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2023-08-21
Enrollment: 25
Sex: ALL
Minimum age (years): 21
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model 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 (OHCit) low dose, Super CitriMax (OHCit) standard dose, or Potassium Citrate. Randomization will be stratified based on sex, concomitant thiazide use, and concomitant alkali use.
Primary purpose: PREVENTION

Brief 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.

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

Primary outcomes:
measure: Formation product (FP) for Calcium Phosphate
timeFrame: After 1 week of treatment
Secondary outcomes:
measure: Crystal growth of Calcium Phosphate
timeFrame: After 1 week of treatment
measure: Calcium Phosphate supersaturation
timeFrame: After 1 week of treatment
Other outcomes:
Locations:
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
Study officials:
affiliation: University of Texas Southwestern Medical Center
name: NAIM M MAALOUF
role: PRINCIPAL_INVESTIGATOR
References: