Hydroxycitrate for preventing calcium phosphate kidney stones
Official title: Hydroxycitrate: A Novel Therapy for Calcium Phosphate Urinary Stones
Run by University of Texas Southwestern Medical Center · NCT06003348 · Data updated 2026-11-12
This study is testing if hydroxycitrate can help prevent calcium phosphate kidney stones from coming back in people who have had them before.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 21 Years to 99 Years |
| Sex | All |
| Enrollment | 25 (estimated) |
| Sponsor | University of Texas Southwestern Medical Center Academic / other |
| Locations | 1 site (Dallas, Texas) |
| Status | Recruiting |
| Started | December 13, 2023 |
| Main results expected | May 31, 2028 |
| Study ends | August 31, 2028 |
| Registry record updated | June 2, 2026 |
| Trial ID | NCT06003348 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are individuals who have a history of forming calcium phosphate kidney stones.
✕Probably not a fit
Patients with conditions such as recurrent urinary tract infections or significant renal impairment may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study evaluates the effectiveness of hydroxycitrate, a compound similar to citrate, in reducing the recurrence of calcium phosphate kidney stones. It employs a double-blind, placebo-controlled, randomized, crossover design, where participants will experience four different treatment phases: placebo, low-dose hydroxycitrate, standard-dose hydroxycitrate, and potassium citrate. Each phase lasts one week, with a washout period in between, and participants will follow a controlled metabolic diet to ensure consistent dietary intake. Urine and blood samples will be collected to analyze the biochemical effects of the treatments.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce the recurrence of calcium phosphate kidney stones in patients.
How similar studies have gone: While the use of citrate for kidney stones has been studied, the specific application of hydroxycitrate in this context is novel and has not been extensively tested.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
UT Southwestern Medical Center
Dallas, Texas, United States Recruiting
Study contacts
- Principal investigator: Naim M Maalouf — University of Texas Southwestern Medical Center
- Study coordinator: Naim M Maalouf, Md
- Email: naim.maalouf@utsouthwestern.edu
- Phone: 214/648-2954
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.