Cobalamin Status in Young Children With Developmental Delay

What Was Tested

In this not phased trial, researchers set out to test Cyanocobalamin (Vitamin B12).

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

It had two arms (groups): 1 (active comparator) and 2 (sham comparator).

The controls receive an intramuscular "injection", however, it is only an introduction of the needle into the muscle, but no injections are given. The syringe is covered so it is impossible to see whether or not it contains any substance.

The registry classes the interventions as dietary supplement.

Who Took Part

100 planned participants were the target.

It was open to people of any sex aged up to 8 months.

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

Examples of who could join: Children below 8 months of age. Clinical diagnosis or symptoms: developmental delay and regression and other vague neurological symptoms.

The full record lists 2 inclusion and 1 exclusion criteria; among the exclusions: children with syndromic disease.

How the Study Was Run

It was run as a randomized, parallel-group and triple-blind 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.

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

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

It started in 2008-06 with completion listed for 2010-08.

It ran at 1 site in Norway.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Outcome Measure: Changes in cobalamin and folate status, including metabolic markers, hematological parameters, neurological evaluation and growth parameters (time frame: Reevalutation after 4 weeks).

It also tracked 1 secondary outcome, for example Maternal evaluation of infant behaviour.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Cyanocobalamin (Vitamin B12) in 100 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.