A NEW 13C BREATH TEST TO DETECT VITAMIN B-12 DEFICIENCY: A PREVALENT AND POORLY DIAGNOSED HEALTH PROBLEM
David A. Wagner1, Richard Schatz2, Richard Coston2, Cheryl Curington2, Daniel Bolt1, and Phillip P. Toskes2 1 Metabolic Solutions, Inc., Nashua, NH, USA 2 University of Florida, Department of Medicine, Division of Gastroenterology, Gainesville, FL, USA
Vitamin B12 deficiency is emerging as a growing public health problem. The most commonly used diagnostic tests are limited in accuracy, sensitivity, and are non-specific for B12 deficiency. The aim of this study was to develop a simple B12 Breath Test (BBT) to more accurately evaluate vitamin B12 status as an alternative to the most common diagnostic test, serum B12 levels. The breath test is based on the metabolism of sodium 1-13C-propionate to 13CO2 which requires B12 as a cofactor. We initially compared the BBT to current B12 diagnostic methods in 58 subjects. Subjects also received a second BBT 1–3 days after initial testing to evaluate reproducibility of results. Propionate dosage, fasting times, and collection periods were compared respectively. The dose of sodium 1-13C-propionate (10 to 50 mg) gave equivalent results while an 8 hour fast was essential. Statistical analysis revealed that breath collection times could be reduced to just a baseline and 10 and 20 minutes following propionate dosing. We also measured the incidence of B12 deficiency with the BBT in 119 patients with chronic pancreatitis, Crohn’s disease, small intestinal bacterial overgrowth, and subjects over 65 years of age. The BBT results agreed with previous publications showing a higher incidence of B12 deficiency in these patients. The BBT may provide clinicians with a non-invasive, accurate, reliable, and reproducible diagnostic test to detect vitamin B12 deficiency.