RESUMO
BACKGROUND: Urolithiasis has high recurrent rate after surgical removal within 3 years. Potassium citrate compound is used to prevent stone recurrence but it has intolerable gastrointestinal adverse effects. We conducted a phase 2 clinical study of lime power regimen (LPR), a limeade-based supplement containing potassium and citrate for 6 months period of treatment, to evaluate its effects on biochemical and clinical aspects of recurrent urolithiasis. METHODS: Seventy-four urolithiasis patients were randomly allocated to receive either LPR or placebo for 6 months in a double-blinded manner. Plasma and 24 h urine samples were collected to measure urinary pH, mineral excretion and urinary total antioxidant status , plasma for creatinine and plasma protein carbonyl, and stone for elemental analysis at the initiation and end-of-treatment (6 month). Adverse effects were recorded. RESULTS: Administration of LPR significantly increased urinary pH, citrate and potassium excretion. Urinary levels of calcium and oxalate, and plasma protein carbonyl content were reduced, while urinary total antioxidant status was elevated by LPR treatment. Urinary supersaturation was decreased and urinary protein excretion was ameliorated in LPR-treated patients. Gastrointestinal adverse effects were rarely observed. None of the participants developed stone recurrence for the duration of the trial. CONCLUSION: Lime power regimen is a potential drug to correct urinary metabolic disorders associated with urolithiasis in high risk stone recurrent patients. A phase 3 clinical trial is underway to validate anti-stone recurrence property of LPR in long-term treatment.