A randomised controlled trial investigating the effect of vitamin B12 supplementation on neurological function in healthy older people: the Older People and Enhanced Neurological function (OPEN) study protocol [ISRCTN54195799]

What Was Tested

This randomized controlled trial paper looks at Cyanocobalamin (Vitamin B12).

Vitamin B12 deficiency may present as macrocytic anaemia, subacute combined degeneration of the spinal cord, or as neuropathy, but is often asymptomatic in older people.

The diagnosis and indications for treatment are clear for individuals with low plasma levels of vitamin B12 in the setting of megaloblastic anaemia and neuropathy, but the relevance of treatment of vitamin B12 deficiency in the absence of such clinical signs is uncertain.

Who Took Part

According to the abstract, 200 people were involved.

PubMed indexes the participants as older adults.

How the Study Was Run

The researchers set it up as 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 primary outcome assessed at 12 months is change in electrophysiological indices of peripheral and central neurosensory responses required for mobility and sensory function.

The researchers here report the detailed study protocol.

What Was Measured

The diagnosis and indications for treatment are clear for individuals with low plasma levels of vitamin B12 in the setting of megaloblastic anaemia and neuropathy, but the relevance of treatment of vitamin B12 deficiency in the absence of such clinical signs is uncertain.

PubMed files the paper under topics including Dietary Supplements, Nervous System Physiological Phenomena, Neural Conduction and Vitamin B 12.

What This Means in Plain Language

The paper is a randomized, double-blind and placebo-controlled study of Cyanocobalamin (Vitamin B12) in 200 people.

The abstract goes on to report its results in about 1 sentences; this page does not restate them, so read the paper for the findings and their limits.

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

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