Cobalamin Supplementation During Infancy; Effect on B-vitamin Status, Growth and Psychomotor Development

What Was Tested

This registered not phased trial tested Cyanocobalamin (Vitamin B12).

The purpose of this study is to determine if cobalamin supplementation may influence the metabolic profile related to cobalamin status in infants.

It had two arms (groups): Cobalamin (experimental) and No intervention (no intervention).

No intervention.

The registry classes the interventions as drug.

More on the Plan

During fetal life and infancy, an adequate cobalamin status is important for normal growth and central nervous system development.

A metabolic profile consistent with impaired cobalamin status is prevalent in breast-fed infants.

Low levels of cobalamin, elevated levels of total homocysteine (tHcy), cystathionine and/or methylmalonic acid (MMA) in the blood are measures of impaired cobalamin status.

The purpose of this randomized, controlled study is to determine if cobalamin supplementation may influence the metabolic profile related to cobalamin status in infants.

Who Took Part

107 actual participants took part.

It was open to people of any sex aged from 4 Weeks up to 4 months.

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

Examples of who could join: 6 weeks old infants. The mother should have an ordinary omnivorous diet.

The full record lists 4 inclusion and 1 exclusion criteria; among the exclusions: if there are evidence of serious infant disease during the study period, the infant should be excluded from the study.

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.

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

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 2004-12 with completion listed for 2006-08.

It ran at 1 site in Norway.

Its stated primary purpose is basic science.

What Was Measured

The main thing measured (primary outcome): Measure: Outcome is related to changes in Cobalamin status: serum levels of cobalamin and folate, and the metabolic markers, plasma-tHcy, cystathionine and MMA (time frame: Infant age 6 weeks - 4 months).

It also tracked 1 secondary outcome, for example Outcome is related to changes in growth parameters; weight, length, head circumference.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Cyanocobalamin (Vitamin B12) in 107 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.