Comparison of two modes of vitamin B12 supplementation on neuroconduction and cognitive function among older people living in Santiago, Chile: a cluster randomized controlled trial. a study protocol [ISRCTN 02694183]

What Was Tested

The paper reports a study of Cyanocobalamin (Vitamin B12), published as a randomized controlled trial.

Older people have a high risk of vitamin B12 deficiency; this can lead to varying degrees of cognitive and neurological impairment.

CBL deficiency may present as macrocytic anemia, subacute combined degeneration of the spinal cord, or as neuropathy, but is often asymptomatic in older people.

Who Took Part

The study group was 300 people.

The age groups tagged for this paper are older adults.

How the Study Was Run

In design terms this was a randomized, double-blind and placebo-controlled study.

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

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

The comparison arm used a placebo, so changes seen with Cyanocobalamin (Vitamin B12) could be set against what happens without it.

The researchers designed a cluster double-blind placebo-controlled trial involving community dwelling people aged 70-79 living in Santiago, Chile.

The researchers randomized 15 clusters (health centers) involving 300 people (20 per cluster).

The primary outcomes assessed at baseline, 4, 9 and 18 months will be: serum levels of vitamin B12, neuroconduction and cognitive function.

What Was Measured

The subject headings attached to it are Chile, Clinical Protocols, Cognition, Cognition Disorders, Dietary Supplements, Food, Fortified and Neural Conduction.

What This Means in Plain Language

The paper is a randomized, double-blind and placebo-controlled study of Cyanocobalamin (Vitamin B12) in 300 people.

With several hundred people or more, it is a fairly large study for this kind of research.

Results are reported in around 1 sentences of the abstract; we leave them to the paper itself rather than summarise them.

The publication is from 2011 (Nutrition journal), a journal based in England.

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