Pharmacological Therapy for Calcium Phosphate Urolithiasis
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Calcium Phosphate Kidney Stones
- Sponsor
- University of Texas Southwestern Medical Center
- Enrollment
- 13
- Locations
- 1
- Primary Endpoint
- Urinary Calcium Phosphate Saturation
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
The investigators will examine in two studies whether citric acid or potassium citrate can reduce calcium phosphate saturation in urine of Calcium Phosphate stone formers.
Detailed Description
We will examine in two short-term placebo-controlled cross-over metabolic studies whether citric acid or potassium citrate can reduce calcium phosphate saturation in urine of CaP stone formers. The first study will be conducted in hypocitraturic CaP stone formers without hypercalciuria, and will compare the effects of potassium citrate, citric acid and placebo. The second study will be conducted in hypercalciuric CaP stone formers on a thiazide diuretic who require potassium supplementation, and will compare the effects of potassium chloride alone, potassium chloride + citric acid, and potassium citrate alone. Physicochemical assays will be applied in addition to computer-based stone risk prediction programs to assess risk of stone recurrence.
Investigators
Naim Maalouf
Associate Professor of Medicine
University of Texas Southwestern Medical Center
Eligibility Criteria
Inclusion Criteria
- •Hypocitraturic CaP stone formers
- •urine citrate \<320mg/d
- •elevated pH as 24-hr urine pH above 6.40
- •\>21 years
- •Hypercalciuric CaP stone formers
- •24hr urine calcium \>250mg/d in women and \>300mg/d in men prior to indapamide use
- •high pH as \>6.40 in the absence of urinary tract infection
- •\>21 years
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Urinary Calcium Phosphate Saturation
Time Frame: 2 weeks
This variable represents a ratio of the calcium phosphate saturation in a given urine sample to the calcium phosphate saturation at the point of precipitation and hence this measure has no units.