A Phase 2 interventional study of Potassium Citrate Supplementation and Dietary Education in Kidney Stone, sponsored by University of North Carolina, Chapel Hill. Withdrawn at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-10-12.
Sponsored by University of North Carolina, Chapel Hill · Phase 2, Interventional, and Prevention
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.
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 alters the solubility of certain stone types including uric acid and cystine stones. Potassium citrate supplementation is the primary proven approach to increasing urinary citrate and is a well-established preventive option in stone disease. However, medication treatment can cause epigastric discomfort, frequent large bowel movements and add to the patient's prescription financial burden. Dietary education including lemonade therapy provides natural dietary sources of citrate and may be an alternative to pharmacologic therapy without the associated gastrointestinal symptoms or costs.
The utility of citrate supplementation has not been previously evaluated prospectively in the calcium phosphate stone former. Calcium phosphate stone formation occurs in a more alkaline urine environment. It has been postulated that citrate supplementation could promote calcium phosphate stone occurrence due to its ability to raise urine pH despite the inhibitory effects of increasing urinary citrate. However, this finding has not been observed in limited retrospective studies. The purpose of this investigation is to prospectively evaluate the benefit of citrate supplementation either through potassium citrate treatment with dietary education vs. dietary education alone to reduce stone recurrence in calcium phosphate stone formers with risk factors.
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Exclusion Criteria:
Participants in this treatment arm will undergo dietary counseling for the prevention of kidney stone formation.
Other: Dietary Education
Participants in this treatment arm will undergo potassium citrate supplementation and dietary counseling for the prevention of kidney stone formation.
Dietary Supplement: Potassium Citrate Supplementation · Other: Dietary Education
20 mEq taken twice daily
Dietary counseling will include both a verbal discussion in the clinic regarding increased fluid intake, a moderate calcium rich diet and lemonade therapy as well as receiving a written handout on these topics.
Change in 24-hour urine parameters
Time frame: 4-6 weeks from baseline
This study is withdrawn, as verified in Sep 2015. You cannot join it, but the record below documents what was studied.
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University of North Carolina, Chapel Hill