Hydroxycitrate: A Novel Therapy for Calcium Phosphate Urinary Stones
1 other identifier
interventional
25
1 country
1
Brief Summary
This study tests whether hydroxycitrate, a molecule closely related to citrate, can reduce calcium phosphate stone recurrence.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Dec 2023
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 14, 2023
CompletedFirst Posted
Study publicly available on registry
August 21, 2023
CompletedStudy Start
First participant enrolled
December 13, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 31, 2028
April 6, 2025
April 1, 2025
4.5 years
August 14, 2023
April 2, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Crystal growth of Calcium Phosphate
After 1 week of treatment
Calcium Phosphate supersaturation
After 1 week of treatment
Study Arms (4)
Potassium Citrate (Urocit®-K)
ACTIVE COMPARATORPotassium Citrate KCit 10 mEq 2 tabs, twice daily and Placebo 1 tab, twice daily Total Daily Dose: Citrate 40 mEq/d
Super CitriMax; OHCit-standard dose
EXPERIMENTALSuper CitriMax 7 mEq 3 tabs, twice daily Total Daily Dose: OHCit 42 mEq/d
Super CitriMax; OHCit-low dose
EXPERIMENTALSuper CitriMax 7 mEq 2 tabs, twice daily And Placebo 1 tab, twice daily Total Daily Dose: OHCit 28 mEq/d
Placebo
PLACEBO COMPARATORPlacebo 3 tablets twice daily Total Daily Dose: None
Interventions
Hydroxycitrate Over-the-counter supplement, not FDA approved or regulated.
10 mEq Extended-release tablets for oral use
Hydroxycitrate Over-the-counter supplement, not FDA approved or regulated.
Eligibility Criteria
You may qualify if:
- \- Calcium Phosphate stone formers
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UT Southwestern Medical Center
Dallas, Texas, 75390-8885, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
NAIM M MAALOUF
University of Texas Southwestern Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor, Internal Medicine
Study Record Dates
First Submitted
August 14, 2023
First Posted
August 21, 2023
Study Start
December 13, 2023
Primary Completion (Estimated)
May 31, 2028
Study Completion (Estimated)
August 31, 2028
Last Updated
April 6, 2025
Record last verified: 2025-04