Ian F Robey, Ana Maria Lopez and Denise J Roe
Objective: Pre-clinical studies have shown that chronic systemic buffering may have a beneficial impact in cancer care. This is a Phase 0/I clinical trial to determine if a sodium bicarbonate dose concentration of 0.5 g/kg/day is feasible and well tolerated as measured by the proportion of subjects with first evidence of adherence failure. The secondary objective was to determine if the dose concentration of 0.5 g/kg/day sodium bicarbonate is safe for long term consumption (90 days) as measured by vital signs and basic metabolic blood panels (BMP).
Methods: Healthy volunteers were recruited to consume 2-3 times per day a total maximum dose of 0.5 g/kg/ day sodium bicarbonate. Volunteers were permitted to downward dose to find a tolerable dose they were willing to consume daily for 90 days. Volunteers returned to the clinic on day 10, 30, 60, and 90 to monitor vital signs, BMP, and urine pH. In between visits, the volunteers recorded their urine pH before and after sodium bicarbonate consumption. Volunteer journals and routine communication between clinical personnel and volunteers was maintained to monitor adherence and adverse events (AEs).
Results: The trial accrued 15 volunteers, 11 women and 4 men. The average age of volunteer was 55 years. The average daily dose was 0.17 ± 0.03 g/kg. Most adverse events were Grade 1. Two AEs were Grade 2. Most symptoms were gastrointestinal in nature. Two subjects withdrew from the study before the 90 day time point. One incidence of metabolic alkalosis occurred and was resolved by downward dose adjustment.
Conclusions: The study demonstrates that voluntary long-term consumption of sodium bicarbonate is feasible and safe, but the predicted upward tolerable dose was too high for healthy volunteers.
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