Vitamin B12 Supplementation to Improve B12 Status and Child Development

What Was Tested

In this not phased trial, researchers set out to test Cyanocobalamin (Vitamin B12).

The newborns and infants of B12-deficient mothers have low B12 stores at birth, further exacerbated by a very low concentration of B12 in breast milk that may hinder their growth and development.

It had two arms (groups): Vitamin B12-fortified UHT milk (active comparator) and Plain UHT milk (placebo comparator).

Supplementation group (N=74) that will receive vitamin B12 fortified UHT milk daily.

Placebo group (N=74) that will receive plain UHT milk daily.

The registry classes the interventions as dietary supplement.

More on the Plan

The investigators aim to conduct a double-blind, randomized trial, to investigate the effects of B12-fortified milk on maternal and infant B12 status, immune function and child development.

The daily supplementation beginning at the baseline visit (GW 11-14) will continue until 6 mo-postpartum.

Biomarkers of B12 status will be measured in mothers (GW 11-14 and 6-mo postpartum) and infants (3 and 6-mo).

Infant development (6 and 12-mo) will be evaluated by Bayley Scales of Infant and Toddler Development.

Who Took Part

Enrollment: 155 actual participants took part.

It was open to people of any sex aged from 18 years up to 35 years.

Healthy volunteers could join, not only people with the condition.

How the Study Was Run

The set-up was randomized, parallel-group and triple-blind.

Because people in this Cyanocobalamin (Vitamin B12) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Groups ran in parallel: each of the participants stayed in one arm throughout.

As a double-blind Cyanocobalamin (Vitamin B12) study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, care provider and investigator.

It started in 2017-09-01 with completion listed for 2021-10-30.

It ran at 1 site in Bangladesh.

Its stated primary purpose is health services research.

What Was Measured

The main thing measured (primary outcome): Change in concentrations of biomarkers of vitamin B12 in mother-child pairs (time frame: Baseline and 6 months postpartum). Vaccine specific immunity in infants (time frame: 6 months). Cognitive, Language and Motor Composite Score (time frame: 12 months).

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Cyanocobalamin (Vitamin B12) in 155 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Cyanocobalamin (Vitamin B12) compound page, all human trials.