Potassium Citrate Supplementation vs. Dietary Counseling
Withdrawn before enrolling · Phase 2
Conditions studied: Kidney Stone
In brief
The purpose of this study is to compare the role of potassium citrate supplementation with dietary education versus dietary education alone in the reduction of stone risks and events in patients with predominantly calcium phosphate kidney stones.
Key facts
- Study ID
- NCT01980004
- Run by
- University of North Carolina, Chapel Hill
- People needed
- 0
- Starts
- 2013-11-01
- Expected to finish
- 2015-08-01
- Last updated by the study team
- 2015-10-12
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients ≥ 18 years old, being seen at UNC Chapel Hill or Vanderbilt Urology Clinics
- Documented stone analysis with ≥ 50% calcium phosphate (hydroxyapatite and/or brushite) composition
- 24 hour urine citrate (≤ 500) on initial evaluation of at least one 24-hour urine study
- 24 hour urine pH ≥ 6.0 on initial evaluation of at least one 24-hour urine study
You may not qualify if…
- Documented stone analysis with any calcium carbonate or magnesium ammonium phosphate composition
- Systemic cause for stone disease (primary hyperparathyroidism, complete distal renal tubular acidosis, systemic acidosis, active urinary tract infection)
- 24 hour urine calcium/kg (> 4) or 24 hour urine calcium/Cr (>140) on initial evaluation of at least one 24-hour urine study
- Concurrent medication therapy (potassium citrate, sodium citrate, sodium bicarbonate, diuretic, angiotensin-converting enzyme inhibitor, angiotensin II receptor antagonist, topiramate, acetazolamide)
- Renal insufficiency (GFR ≤ 60)
- Elevated serum potassium level (≥ 4.5) or hyperkalemia
- Low serum bicarbonate level (< 24)
- High serum calcium level (>10)
- Pregnancy
- Inability to obtain informed consent
Where it is running
- North Carolina Memorial Hospital — Chapel Hill, North Carolina, United States
Full record on ClinicalTrials.gov
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