Abstract
BackgroundVitamin B12 deficiency is one of the most common micronutrient deficiencies and is associated with poor cognitive development and growth. Vitamin B12 is crucial for normal cell division and differentiation, and it is necessary for the development and myelination of the central nervous system. The aim of the present study is to measure the effect of daily supplementation of vitamin B12 on the neurodevelopment and growth of young children in Nepal.Methods/designWe are conducting an individually randomized, double-blind, placebo-controlled trial with 600 marginally stunted children 6–11 months old (length for age less than −1 z-score). Children are randomized to receive a lipid-based paste containing vitamin B12 or placebo daily for 12 months. The main outcomes are changes in growth (z-scores) and in neurodevelopment measured by the Bayley Scales of Infant and Toddler Development, Third Edition, from baseline until the end of the study.DiscussionIf vitamin B12 supplementation benefits early child development and growth, this will have consequences for dietary recommendations for malnourished children worldwide.Trial registrationsClinicalTrials.gov Identifier: NCT02272842. Registered on 21 October 2014.Universal Trial Number: U1111-1161-5187. Registered on 8 September 2014.
Highlights
Vitamin B12 deficiency is one of the most common micronutrient deficiencies and is associated with poor cognitive development and growth
We found a beneficial effect of vitamin B12 supplementation for 6 months on neurodevelopment in young North Indian children [16]
Specific aims of the study The specific aims of the study are to measure, in infants 6–11 months of age in a population where poor vitamin B12 status and malnutrition is common, the following: 1. To what extent administration of 2 μg of vitamin B12 for 1 year improves developmental scores measured by the Bayley Scales of Infant and Toddler Development, Third Edition (Bayley-III), and the Ages and Stages Questionnaire, Third Edition (ASQ-3)
Summary
Vitamin B12 deficiency is one of the most common micronutrient deficiencies and is associated with poor cognitive development and growth. The aim of the present study is to measure the effect of daily supplementation of vitamin B12 on the neurodevelopment and growth of young children in Nepal. Vitamin B12 deficiency is associated with impaired infant and child growth [4, 5]. In several studies of women and children, we have demonstrated that poor vitamin B12 status is common in South Asia [3, 6, 7]. Case studies have demonstrated harmful effects of severe vitamin B12 deficiency on the developing infant brain [8, 9]. Researchers in three randomized controlled trials (RCTs) have measured the effect of vitamin B12 supplementation on neurodevelopment in children. In a Norwegian trial, an intramuscular injection of vitamin B12 substantially improved motor development in 6-week-old infants after
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