Effect of Toothpaste Fortified With Cyanocobalamin on Vitamin B12 Status

What Was Tested

The trial (not phased) is built around Cyanocobalamin (Vitamin B12).

A 3 months randomized, placebo-controlled study on the effect of toothpaste fortified with vitamin B12 on vitamin B12 status markers and related metabolic markers.

The primary outcome variable is the difference in the change of methylmalonic acid after 3 months between the two study arms.

It had two arms (groups): Placebo (placebo comparator) and Cyanocobalamin (active comparator).

A toothpaste, with the same matrix, all components, and appearance like the active arm but not containing vitamin B12.

The registry classes the interventions as dietary supplement.

Who Took Part

Enrollment: 180 actual participants took part.

It was open to people of any sex aged from 18 years up to 75 years.

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

Examples of who could join: Adults: men and women. Stable diet for at least 24 months (omnivorous or a vegan diet).

The full record lists 2 inclusion and 6 exclusion criteria; among the exclusions: pregnancy and lactation; malabsorption disorders (crohn disease, chronic gastritis, pernicious anemia, gastric or intestinal resection); renal diseases.

How the Study Was Run

Design: randomized, parallel-group and single-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.

In this single-blind Cyanocobalamin (Vitamin B12) study one party knew the assignments and the other did not.

Those kept unaware of assignments: participant.

It started in 2014-11 with completion listed for 2015-12.

It ran at 2 sites in Germany (2).

Its stated primary purpose is prevention.

What Was Measured

The main thing measured (primary outcome): The change in plasma concentrations of methylmalonic acid (time frame: Baseline, 3 months). The change in plasma concentrations of holotranscobalamin (time frame: Baseline, 3 months). The change in plasma concentrations of homocysteine (time frame: Baseline, 3 months).

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Cyanocobalamin (Vitamin B12) in 180 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.