Recruiting

Hydroxycitrate

Sponsor:

University of Texas Southwestern Medical Center

Code:

NCT06003348

Conditions

Calcium Phosphate Kidney Stones

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Not accepted

Interventions

OHCit- standard dose

Potassium Citrate

Placebo

OHCit- low dose

Study Details

Brief summary:

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

Conditions

Calcium Phosphate Kidney Stones

Study ID

NCT06003348

Start date

Dec 13, 2023

Status verified date

Jun, 2026

Completion date

Aug 31, 2028

Anticipated

Primary completion date

May 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

25 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

active comparator: Potassium Citrate (Urocit®-K)

Potassium Citrate KCit 10 mEq 2 tabs, twice daily and Placebo 1 tab, twice daily Total Daily Dose: Citrate 40 mEq/d

experimental: Super CitriMax; OHCit-standard dose

Super CitriMax 7 mEq 3 tabs, twice daily Total Daily Dose: OHCit 42 mEq/d

experimental: Super CitriMax; OHCit-low dose

Super CitriMax 7 mEq 2 tabs, twice daily And Placebo 1 tab, twice daily Total Daily Dose: OHCit 28 mEq/d

placebo comparator: Placebo

Placebo 3 tablets twice daily Total Daily Dose: None

Interventions

OHCit- standard dose

Hydroxycitrate Over-the-counter supplement, not FDA approved or regulated.

Potassium Citrate

10 mEq Extended-release tablets for oral use

Placebo

Placebo

OHCit- low dose

Hydroxycitrate Over-the-counter supplement, not FDA approved or regulated.

Primary outcome measure

  • Formation product (FP) for Calcium Phosphate [ Time Frame: After 1 week of treatment ]

Central Contacts and Locations

Central contacts

NAIM M MAALOUF, MD

214/648-2954naim.maalouf@utsouthwestern.edu

Miranda King

2146482117Miranda.King@utsouthwestern.edu

Locations

UT Southwestern Medical Center

Recruiting

Dallas, Texas, United States, 75390-8885

More Information

Sponsor

University of Texas Southwestern Medical Center

Last update posted

Jun 2, 2026

Last verified

Jun, 2026

Keywords

  • Urolithiasis
  • Calcium phosphate
  • Citrate
  • Acid-base

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Texas Southwestern Medical Center on 2026-06-02.