Treatment for Calcium Phosphate Kidney Stone Disease
Information source: University of Texas Southwestern Medical Center
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Calcium Phosphate Kidney Stones
Intervention: Placebo (Drug); Citric Acid (Dietary Supplement); Potassium Citrate (Dietary Supplement); Indapamide (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: University of Texas Southwestern Medical Center Official(s) and/or principal investigator(s): Naim M Maalouf, MD, Principal Investigator, Affiliation: UT Southwestern Medical Center
Overall contact: Ann Heard-Sakhaee, RN, Phone: 214-648-4893, Email: ann.heard-sakhaee@utsouthwestern.edu
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.
Clinical Details
Official title: Pharmacological Therapy for Calcium Phosphate Urolithiasis
Study design: Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Urinary calcium phosphate saturation
Eligibility
Minimum age: 21 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
Aim 1
- Hypocitraturic CaP stone formers
- urine citrate <320mg/d
- elevated pH as 24-hr urine pH above 6. 40
- >21 years
Aim 2
- 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
Locations and Contacts
Ann Heard-Sakhaee, RN, Phone: 214-648-4893, Email: ann.heard-sakhaee@utsouthwestern.edu
UT Southwestern Medical Center, Dallas, Texas 75390-8885, United States; Recruiting Naim M Maalouf, MD
Additional Information
Starting date: July 2012
Last updated: February 3, 2015
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