The effect of infant vitamin B(12) supplementation on neurodevelopment: a follow-up of a randomised placebo-controlled trial in Nepal

The most critical period for brain development is before a child’s second birthday. Standardised tests measuring neurodevelopment are more reliable when administered after this period. Severe vitamin B(12) deficiency affects brain development and function. In a randomised, double-blind, placebo-controlled trial in 600 Nepalese infants (6–11 months at enrolment), we found no effect of 2 µg vitamin B(12) daily for a year on neurodevelopment. The primary objective of the current study was to measure the effect of the intervention on the Wechsler Preschool and Primary Scale of Intelligence (WPPSI-IV) full scale intelligence quotient (FSIQ). We measured the effect on the Bayley Scales of Infant and Toddler Development 3rd edition at age 30–35 months (n 555). At age 42–47 months (n 533), we used the WPPSI-IV and subtests from the Neuropsychological Assessment, 2nd edition (NEPSY-II). We also used the FSIQ to estimate subgroup specific effects. The mean (sd) WPPSI-IV FSIQ in the vitamin B(12) group was 84·4 (8·4) and 85·0 (8·6) in the placebo group (mean difference −0·5 (95 % CI -1·97, 0·94), P = 0·48). There were no effect of the vitamin B(12) on any of the other neurodevelopmental outcomes and no beneficial effect in any of the subgroups. In conclusion, providing 2 µg of vitamin B(12) for a year in infants at risk of vitamin B(12) deficiency does not improve preschool cognitive function.