Oral Vitamin B12 Supplementation and Cognitive Performance in Elderly People

What Was Tested

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

The purpose of this trial is to study the effects of oral vitamin B12 supplementation and vitamin B12 combined with folic acid supplementation on cognitive performance for 24 weeks in elderly people with mild vitamin B12 deficiency.

The registry classes the interventions as behavioral.

More on the Plan

Mild vitamin B12 deficiency is highly prevalent in old age.

Reasons for this high prevalence are not fully understood, but include atrophic gastritis and bacterial overgrowth which affect the absorption (active) of food-bound vitamin B12.

In contrast, the ability to absorb crystalline vitamin B12 (e.g. the form found in fortified foods or vitamin pills) remains intact in old age.

Who Took Part

The registry lists 165 planned participants were the target.

It was open to people of any sex aged from 70 years with no upper age limit.

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

Examples of who could join: Mild vitamin B12 deficiency:. Elevated methylmalonic acid (MMA) concentration (\> 0.32 umol/L). Creatinine concentration \< 120 umol/L.

The full record lists 4 inclusion and 7 exclusion criteria; among the exclusions: severe cognitive impairment; gastrointestinal surgery or diseases; no written informed consent.

How the Study Was Run

Design: randomized, parallel-group and double-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.

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

It started in 2003-05 with completion listed for 2005-01.

It ran at 1 site in Netherlands.

Its stated primary purpose is prevention.

What Was Measured

The main thing measured (primary outcome): Cognitive performance in the domains of attention, concentration, memory, executive function, speed.

It also tracked 1 secondary outcome, for example Blood biochemistry including vitamin B12, methylmalonic acid, holotranscobalamin, homocysteine, and red blood cell folate.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Cyanocobalamin (Vitamin B12) in 165 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.