Hydroxycitrate for preventing calcium phosphate kidney stones
Hydroxycitrate: A Novel Therapy for Calcium Phosphate Urinary Stones
PHASE4 · University of Texas Southwestern Medical Center · NCT06003348
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 | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 25 (estimated) |
| Ages | 21 Years to 99 Years |
| Sex | All |
| Sponsor | University of Texas Southwestern Medical Center (other) |
| Locations | 1 site (Dallas, Texas) |
| Trial ID | NCT06003348 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals who have a history of forming calcium phosphate kidney stones.
Not a fit: Patients with conditions such as recurrent urinary tract infections or significant renal impairment may not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Dallas, Texas
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Calcium Phosphate Kidney Stones, Urolithiasis, Calcium phosphate, Citrate, Acid-base