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Search / Trial NCT01980004

Potassium Citrate Supplementation vs. Dietary Counseling

Launched by UNIVERSITY OF NORTH CAROLINA, CHAPEL HILL · Nov 1, 2013

Trial Information

Current as of August 26, 2025

Withdrawn

Keywords

ClinConnect Summary

The prevalence of kidney stone disease in the United States is increasing. Concurrently, an increase in calcium phosphate stone composition is also being observed. Recurrence of kidney stone disease has been reported as high as 50% at five years. Citrate supplementation is widely considered as one of the primary medical cornerstones to decrease kidney stone recurrence. Urinary citrate is a potent inhibitor of calcium stone formation by binding ionic urinary calcium as well as direct inhibition of calcium oxalate formation. Additionally, increased citrate, an alkali, raises urine pH which al...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 1. Patients ≥ 18 years old, being seen at UNC Chapel Hill or Vanderbilt Urology Clinics
  • 2. Documented stone analysis with ≥ 50% calcium phosphate (hydroxyapatite and/or brushite) composition
  • 3. 24 hour urine citrate (≤ 500) on initial evaluation of at least one 24-hour urine study
  • 4. 24 hour urine pH ≥ 6.0 on initial evaluation of at least one 24-hour urine study
  • Exclusion Criteria:
  • 1. Documented stone analysis with any calcium carbonate or magnesium ammonium phosphate composition
  • 2. Systemic cause for stone disease (primary hyperparathyroidism, complete distal renal tubular acidosis, systemic acidosis, active urinary tract infection)
  • 3. 24 hour urine calcium/kg (\> 4) or 24 hour urine calcium/Cr (\>140) on initial evaluation of at least one 24-hour urine study
  • 4. Concurrent medication therapy (potassium citrate, sodium citrate, sodium bicarbonate, diuretic, angiotensin-converting enzyme inhibitor, angiotensin II receptor antagonist, topiramate, acetazolamide)
  • 5. Renal insufficiency (GFR ≤ 60)
  • 6. Elevated serum potassium level (≥ 4.5) or hyperkalemia
  • 7. Low serum bicarbonate level (\< 24)
  • 8. High serum calcium level (\>10)
  • 9. Pregnancy
  • 10. Inability to obtain informed consent

About University Of North Carolina, Chapel Hill

The University of North Carolina at Chapel Hill (UNC) is a leading research institution renowned for its commitment to advancing health and science through innovative clinical trials. With a robust infrastructure that supports multidisciplinary collaboration, UNC conducts cutting-edge research across various fields, including medicine, public health, and biomedical sciences. The university is dedicated to improving patient care and health outcomes by translating its research findings into practical applications. UNC’s clinical trials are designed to evaluate new therapies, interventions, and technologies, ensuring that they meet the highest ethical and scientific standards while fostering a culture of inclusivity and community engagement.

Locations

Chapel Hill, North Carolina, United States

Patients applied

0 patients applied

Trial Officials

Davis J Viprakasit, MD

Principal Investigator

University of North Carolina, Chapel Hill

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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