Efficacy of B12 fortified nutrient bar and yogurt in improving plasma B12 concentrations Results from two double blind randomised placebo controlled trials

Abstract

Background: Dietary vitamin B12 (B12) deficiency is common in Indians. It may affect hematologic and neurocognitive systems and maternal deficiency predisposes offspring to neural tube defects and non-communicable disease. Long term tablet supplementation is not sustainable. Objective: To study efficacy of B12 fortified nutrient bar and yogurt in improving plasma B12 concentrations in children and adults. Methods: Two double blind, placebo-controlled randomised directly observed therapy (DOT) trials were conducted: 1. Healthy children (10 to 13Y) were fed nutrient bar fortified with B12 (2 mcg), multiple micronutrients (B12 1.8 mcg) or placebo for 120 days. 2. Healthy adults (18 to 50Y) were fed yogurt fortified with B12 (2 mcg) or Propionibacterium (1 into 108cfu/g) or placebo for 120 days. B12, folate, homocysteine and hemoglobin concentrations and anthropometry were measured before and post intervention. Results: We randomised 164 children and 118 adults; adherence was 96% and 82% respectively. In children, B12 fortified bars increased B12 concentrations significantly above baseline (B12 alone: median plus 91 pmol/l, B12 multiple micronutrients: 82 pmol/l) compared to placebo. In adults, B12 fortified yogurt increased B12 significantly (median plus 38 pmol/l) compared to placebo, but Propionibacterium did not. In both trials, homocysteine fell significantly with B12 supplementation. There was no significant difference in different groups in anthropometry and hemoglobin. Conclusions: B12 fortified foods are effective in improving B12 status in Indian children and adults. They could be used to improve vitamin B12 status in the national programs for children, adolescents and women of reproductive age. They could also be used as over the counter products.