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Treatment for Calcium Phosphate Kidney Stone Disease

NCT01754779 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2024-04-04

Study results available
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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.

Conditions

  • Calcium Phosphate Kidney Stones

Interventions

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)

Sponsors & Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    collaborator NIH

  • University of Texas Southwestern Medical Center

    lead OTHER

Principal Investigators

  • Naim M Maalouf, MD · UT Southwestern Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-07-31
Primary Completion
2023-02-16
Completion
2023-02-16

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01754779 on ClinicalTrials.gov