NCT01754779

Treatment for Calcium Phosphate Kidney Stone Disease

Pharmacological Therapy for Calcium Phosphate Urolithiasis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: University of Texas Southwestern Medical Center · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Calcium Phosphate Kidney Stones

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Placebo	3 tablets twice daily of matching placebo during the placebo phase.
DIETARY_SUPPLEMENT	Citric Acid	3, 10 mEq tablets of H3Cit twice daily during the H3Cit phase (60 mEq H3Cit per day)
DIETARY_SUPPLEMENT	Potassium Citrate	2, 10 mEq K3Cit tablets and 1 placebo tablet twice daily during the K3Cit phase (40 mEq K3Cit per day)

Timeline

• Start date: 2012-07-01
• Primary completion: 2023-02-16
• Completion: 2023-02-16
• First posted: 2012-12-21
• Last updated: 2024-04-04
• Results posted: 2024-04-04

Locations

1 site across 1 country: United States