Hydroxycitrate: A Novel Therapy for Calcium Phosphate Urinary Stones

Calcium Phosphate Kidney Stones Clinical Trial

Official title:

Hydroxycitrate: A Novel Therapy for Calcium Phosphate Urinary Stones

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06003348
• Other study ID #: 2023-0339
• Status: Recruiting
• Phase: Phase 4
• Start date: December 13, 2023
• Est. completion date: August 31, 2028

Study information

• Verified date: April 2024
• Source: University of Texas Southwestern Medical Center
• Contact: NAIM M MAALOUF, MD
• Phone: 214/648-2954
• Email: naim.maalouf[@]utsouthwestern.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: August 31, 2028
• Est. primary completion date: May 31, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Calcium Phosphate Kidney Stones
• Kidney Calculi
• Urinary Calculi
• Urolithiasis

Intervention

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
• Placebo
Placebo

Dietary Supplement:
• OHCit- low dose
Hydroxycitrate Over-the-counter supplement, not FDA approved or regulated.

Locations

Country	Name	City	State
United States	UT Southwestern Medical Center	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Formation product (FP) for Calcium Phosphate	FP is obtained by adding increasing amounts of Calcium Chloride (CaCl2) to a series of urine aliquots maintained at constant pH for 2 hours, and is identified by the point at which calcium phosphate (CaP) precipitates as detected by an absorbance microplate reader.; Calculated supersaturation using [Calcium] and [Phosphate] at that point represents FP.	After 1 week of treatment
Secondary	Crystal growth of Calcium Phosphate	We will assess crystal growth (CG) of CaP after seeding urine with a small amount of brushite (0.25 mg/ml urine) and incubating at 37°C for 3 hours (representing steady state) under constant stirring. A decrement in [Calcium]×[Phosphate] after seeding signifies crystal growth, while a [Calcium]×[Phosphate] increment represents crystal dissolution.	After 1 week of treatment
Secondary	Calcium Phosphate supersaturation	Supersaturation of calcium phosphate will be assessed by Joint Expert Speciation System (JESS).	After 1 week of treatment