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Completed

NCT Number: NCT01754779

Treatment for Calcium Phosphate Kidney Stone Disease

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.

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Key information

Conditions

Calcium Phosphate Kidney Stones Calculi Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hypercalciuria Kidney Calculi Kidney Diseases Male Urogenital Diseases Nephrolithiasis Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Calculi Urogenital Diseases Urolithiasis Urologic Diseases Urological Manifestations

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

UT Southwestern Medical Center

Dallas, Texas, 75390-8885, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo

Dietary Supplement

3 tablets twice daily of matching placebo during the placebo phase.

Citric Acid

Dietary Supplement

3, 10 mEq tablets of H3Cit twice daily during the H3Cit phase (60 mEq H3Cit per day)

Potassium citrate

Dietary Supplement

2, 10 mEq K3Cit tablets and 1 placebo tablet twice daily during the K3Cit phase (40 mEq K3Cit per day)

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University of Texas Southwestern Medical Center

Other

Collaborators

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

Registry information

Official study title

Pharmacological Therapy for Calcium Phosphate Urolithiasis

Important dates

Study start
2012
Primary completion
2023
Study completion
2023
First posted
Dec 21, 2012
Registry last updated
Apr 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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