Hydroxycitrate: A Novel Therapy for Calcium Phosphate Urinary Stones
NCT ID: NCT06003348
Last Updated: 2025-04-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
25 participants
INTERVENTIONAL
2023-12-13
2028-08-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
PREVENTION
QUADRUPLE
Study Groups
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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
Potassium Citrate
10 mEq Extended-release tablets for oral use
Super CitriMax; OHCit-standard dose
Super CitriMax 7 mEq 3 tabs, twice daily Total Daily Dose: OHCit 42 mEq/d
OHCit- standard dose
Hydroxycitrate Over-the-counter supplement, not FDA approved or regulated.
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
OHCit- low dose
Hydroxycitrate Over-the-counter supplement, not FDA approved or regulated.
Placebo
Placebo 3 tablets twice daily Total Daily Dose: None
Placebo
Placebo
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Chronic diarrhea
* Estimated Glomerular Filtration Rate (eGFR) \< 45 ml/min/1.73 m2
* History of primary hyperparathyroidism
* Hypokalemia
* Hyperkalemia
* Pregnancy
21 Years
99 Years
ALL
No
Sponsors
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University of Texas Southwestern Medical Center
OTHER
Responsible Party
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Naim Maalouf
Professor, Internal Medicine
Principal Investigators
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NAIM M MAALOUF
Role: PRINCIPAL_INVESTIGATOR
University of Texas Southwestern Medical Center
Locations
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UT Southwestern Medical Center
Dallas, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Naim M Maalouf, MD
Role: primary
Other Identifiers
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2023-0339
Identifier Type: -
Identifier Source: org_study_id
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