Vitamin B12 Supplementation During Pregnancy on Cognitive Development

What Was Tested

This registered phase 2, phase 3 trial tested Cyanocobalamin (Vitamin B12) for anemia.

Scientific basis: Globally, vitamin B12 deficiency is one of the most common micronutrient deficiencies.

Vitamin B12 is crucial for normal cell division and differentiation, and necessary for the development and myelination of the central nervous system.

It had two arms (groups): Vitamin B12 (experimental) and Placebo (placebo comparator).

Identical taste and appearance with the Experimental arm. Contains no cobalamin.

The registry classes the interventions as dietary supplement.

More on the Plan

Cobalamin (Vitamin B12) deficiency is common in many low- and middle-income countries.

This is not surprising as the main source of vitamin B12 is animal source foods, which are expensive and for cultural and religious reasons often not eaten at all.

There is also compelling evidence that vitamin B12 deficiency occurs frequently in many other settings including pregnant women .

Another intervention study in low birth weight children in Norway recently confirmed these findings.

Who Took Part

Enrollment: 800 actual participants took part.

It was open to women only aged from 20 years up to 40 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Pregnant mother in early pregnancy and not later than 15 weeks of pregnancy. Current resident and plan to reside in Bhaktapur district for at least the next 2 years. Age of mother between 18 and 40 years. Consent to participate in the study.

The full record lists 4 inclusion and 5 exclusion criteria; among the exclusions: taking or plan to take dietary or multivitamin supplements containing vitamin b12; known case of chronic disease like asthma, tuberculosis, diabetes, hypertension, hypo or hyperthyroidism or others; known case of current high risk pregnancy.

How the Study Was Run

Design: randomized, parallel-group and quadruple-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.

The Cyanocobalamin (Vitamin B12) group and the comparison group ran side by side rather than switching.

Blinding on both sides kept the anemia participants and researchers unaware of who received Cyanocobalamin (Vitamin B12).

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

It started in 2017-03-27 with completion listed for 2022-06-28.

It ran at 1 site in Nepal.

Its stated primary purpose is prevention.

What Was Measured

The main thing measured (primary outcome): Length (time frame: 12 months of age). Neurodevelopment (time frame: measured 6 and 12 months of age).

It also tracked 14 secondary outcomes, for example Child hemoglobin concentration, Child development ASQ, Child development Bayley, Heart rate variability, Sleep and activity and The Infant Motor Performance.

What This Means in Plain Language

Put simply, this is a phase 2, phase 3, randomized trial of Cyanocobalamin (Vitamin B12) in 800 people with anemia.

With 800 participants it is a large trial for this field.

Its status is active not recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Cyanocobalamin (Vitamin B12) compound page, Anemia research.