Vitamin B12 Supplement to Prevent Cognitive Decline

What Was Tested

In this phase 4 trial, researchers set out to test Cyanocobalamin (Vitamin B12).

Background: Older diabetic people are at greater risk of cognitive decline than non-diabetic people.

Vitamin B12 deficiency may therefore contribute to cognitive decline in older diabetic people.

It had two arms (groups): Vitamin B12 (experimental) and Placebo (placebo comparator).

Placebo comparator.

The registry classes the interventions as dietary supplement.

Who Took Part

The registry lists 271 actual participants took part.

It was open to people of any sex aged from 70 years up to 100 years.

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

Examples of who could join: \>/= 70 years old. Caregiver (personal contact at least once a week).

The full record lists 3 inclusion and 5 exclusion criteria; among the exclusions: peripheral neuropathy; renal failure (creatinine \> 150 µmol/l.

How the Study Was Run

Design: randomized, parallel-group and double-blind.

Because people in this Cyanocobalamin (Vitamin B12) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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

Neither the participants nor the staff measuring them knew who was on Cyanocobalamin (Vitamin B12), so expectations could not easily colour the readings.

Those kept unaware of assignments: participant and investigator.

It started in 2011-08 with completion listed for 2016-01.

It ran at 1 site in China.

Its stated primary purpose is prevention.

What Was Measured

Primary outcome: Change in Clinical Dementia Rating Scale (CDR) (time frame: Change from baseline in CDR at month 9, 18, 27).

It also tracked 2 secondary outcomes, for example Change in Neurocognitive test battery (NTB) score and Change in serum homocysteine (µmol/L).

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Cyanocobalamin (Vitamin B12) in 271 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.