Vitamin B12, Neurodevelopment and Growth in Nepal

What Was Tested

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

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

The only relevant source of Vitamin B12 is animal-source foods.

Vitamin B12 is crucial for normal cell division and is necessary for brain growth as well as for the maintenance of its normal function.

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

A paste containing no vitamin administered every day. The paste also contains 1 RDA of several vitamins, but no vitamin B12. The paste is produced by Compact (Norway / India).

The registry classes the interventions as dietary supplement.

More on the Plan

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

The only relevant source of vitamin B12 is animal-source foods.

Vitamin B12 is crucial for normal cell division and differentiation and is necessary for the development and initial myelination of the central nervous system as well as for the maintenance of its normal function.

The researchers saw an effect on both ponderal (weight for age z scores) and linear (height for age z scores) growth.

Who Took Part

Enrollment: 600 actual participants took part.

It was open to people of any sex aged from 6 months up to 11 months.

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

Examples of who could join: Age 6 to 11 months. Availability of informed verbal consent. Plan to reside in the area for the next 12 months.

The full record lists 4 inclusion and 6 exclusion criteria; among the exclusions: severe systemic illness requiring hospitalization; lack of consent; taking b vitamin supplements that include vitamin b12.

How the Study Was Run

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

The participants were allocated by chance, so the Cyanocobalamin (Vitamin B12) group and the comparison group should start out alike.

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

Neither the participants nor the staff measuring them knew who was on Cyanocobalamin (Vitamin B12), so expectations could not easily colour the readings.

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

It started in 2015-04-20 with completion listed for 2018-02-28.

It ran at 1 site in Nepal.

Its stated primary purpose is prevention.

What Was Measured

Primary outcome: The Bayley Scales of Infant Development Version 3 (time frame: 12 months). Hemoglobin Concentration (time frame: 12 months).

It also tracked 8 secondary outcomes, for example Growth Velocity Over the First Six Months of Supplementation, The Effect of Vitamin B12 Supplementation on Markers of Vitamin B Status, Neurodevelopment Measured by Other Tools, Immediate Adverse Effects of the Intervention, Leucocyte Telomere Length and Sleep Duration.

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.

Its status is unknown; results are posted on the registry, and this page does not restate them.

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