The effects of vitamin B12 supplementation in pregnancy and postpartum on growth and neurodevelopment in early childhood: Study Protocol for a Randomized Placebo Controlled Trial

Abstract:

Introduction Vitamin B12 is crucial for normal cell division
and differentiation, and necessary for the development
and myelination of the central nervous system. Pregnant
mothers in resource poor settings are at risk for poor
vitamin B12 status. Poor vitamin B12 status in infancy
is linked to poor growth and neurodevelopment. Brain
development starts from conception, and pregnancy is a
period of rapid growth and development for the brain.
Methods and analysis The study is an individually
randomised double-blind placebo controlled trial in 800
pregnant Nepalese women randomised in a 1:1 ratio. A daily
dose of 50 μg of vitamin B12 or placebo is given to women
from early pregnancy, not later than week 15, until 6 months
after birth. Weekly visits are conducted in order to record
compliance, growth and morbidity. The primary outcomes are
scores on the cognitive, language and motor subscales of the
Bayley Scales of Infant and Toddler Development, Third Edition,
measured at 6 and 12 months of age, and growth (length and
weight) measured at 6 and 12 months of age.
Ethics and dissemination National Health and Research
Council, Nepal (NHRC 253/2016) and Regional Committee
for Medical and Health Research Ethics of Western
Norway (2016/1620/REK vest) have approved the study.
Investigators who have contributed to the conceptualising,
conducting, as well as being involved in the data analyses
and manuscript writing will be eligible for authorship
and be responsible to share outcomes with different
stakeholders through publications and workshops.
The results from this study may support new dietary
guidelines for Nepalese and possibly South Asian pregnant
women that can lead to improved pregnancy outcomes,
neurodevelopment and cognitive functioning in children.
Trial registration number Universal Trial Number:
U1111-1183-4093. Trial registration: clinicaltrials. gov:
NCT03071666. Protocol date: version 1.2, 1 June 2017.

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