WithdrawnPhase 2

Potassium Citrate Supplementation vs. Dietary Counseling

Stopped: closure due to failure to recruit any patients that met study criteria

United States0Started 2013-11

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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

Exclusion criteria

✕. 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)

What they're measuring

Change in 24-hour urine parameters

Timeframe: 4-6 weeks from baseline

Trial details

NCT IDNCT01980004

SponsorUniversity of North Carolina, Chapel Hill

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2015-08

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