The effect of vitamin B12 supplementation during pregnancy on infant growth and development in Nepal: a community-based, double-blind, randomised, placebo-controlled trial.

What Was Tested

The paper reports a study of Cyanocobalamin (Vitamin B12), published as a randomized controlled trial.

Vitamin B12 is required for healthy infant growth and development, but low and marginal vitamin B12 status is endemic in low-income and middle-income countries.

The researchers aimed to measure the effect of vitamin B12 supplementation from early pregnancy until 6 months post partum on infant growth and neurodevelopment.

Who Took Part

According to the abstract, 800 women were involved.

PubMed indexes the participants as infants, women only.

Independent scientists generated the list that linked allocation to participants' study identification number.

Participants were masked to group assignment and all investigators were masked until data cleaning was completed.

How the Study Was Run

In design terms this was a randomized, double-blind and placebo-controlled study.

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.

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

The comparison arm used a placebo, so changes seen with Cyanocobalamin (Vitamin B12) could be set against what happens without it.

The primary outcomes were length-for-age Z score (LAZ) at age 12 months and the cognitive composite score of the Bayley Scales of Infant and Toddler Development (3rd edition) at age 6 months and 12 months.

The primary and secondary outcomes, including adverse events, were assessed in the intention-to-treat population, for all participants with available outcome data.

This trial is registered with ClinicalTrials.gov, NCT03071666.

What Was Measured

The researchers aimed to measure the effect of vitamin B12 supplementation from early pregnancy until 6 months post partum on infant growth and neurodevelopment.

PubMed files the paper under topics including Vitamin B 12, Nepal, Dietary Supplements and Growth and Development.

What This Means in Plain Language

The paper is a randomized, double-blind and placebo-controlled study of Cyanocobalamin (Vitamin B12) in 800 women.

With several hundred people or more, it is a fairly large study for this kind of research.

The abstract goes on to report its results in about 9 sentences; this page does not restate them, so read the paper for the findings and their limits.

The publication is from 2023 (Lancet (London, England)), a journal based in England.

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