Early Infant Micronutrition and Development

What Was Tested

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

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): Screening - treatment (experimental) and Control (no intervention).

From 6 weeks of age, infants will be screened for elevated plasma total homocysteine concentrations. Those who have a concentration above the defined cut-off will be treated with cobalamin (vitamin B12).

The control-group sample will be stored and analyzed when the child is 12 months old. Those with elevated tHcy will contribute to the control group.

The registry classes the interventions as biological.

Who Took Part

Enrollment: 600 planned participants were the target.

It was open to people of any sex aged from 1 Month up to 2 months.

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

Examples of who could join: Availability of informed verbal consent. Plan to reside in the defined study area for the next 12 months. Mothers intend to breastfeed their children for at least 8 months, and exclusively for 4 months.

The full record lists 3 inclusion and 4 exclusion criteria; among the exclusions: severe systemic illness requiring hospitalization; growth retardation; severe congenital malformations.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

Random assignment meant chance, not the researchers, decided who got Cyanocobalamin (Vitamin B12) and who got the comparison, which limits bias.

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

Everyone knew when Cyanocobalamin (Vitamin B12) was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2021-12-08 with completion listed for 2025-10-15.

It ran at 1 site in Norway.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Neurodevelopment (time frame: 12 months of age). Prevalence of vitamin B12 deficiency (time frame: 1-3 months of age). Prevalence of other vitamin deficiencies (time frame: 1-3 months of age).

It also tracked 5 secondary outcomes, for example Neurodevelopment measured by the Ages and Stages Questionaire, Vagal tone, Eye tracking, Neurodevelopment later in childhood and Adverse events.

What This Means in Plain Language

Put simply, this is a phase 2, phase 3, randomized trial of Cyanocobalamin (Vitamin B12) in 600 people.

With 600 participants it is a large trial for this field.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

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