Effect of Toothpaste Fortified With Cyanocobalamin on Vitamin B12 Status

Effect of Toothpaste Fortified With Cyanocobalamin on Vitamin B12 Status: A 3 Month Placebo Controlled Randomized Study

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02679833

Enrollment

180

Registered

2016-02-10

Start date

2014-11-30

Completion date

2015-12-31

Last updated

2018-05-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cobalamin Deficiency

Keywords

Cobalamin biomarkers, Anemia, Vegan diet, Subclinical, Metabolic functional markers, Holotranscobalamin, Methylmalonic acid

Brief summary

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.

Interventions

DIETARY_SUPPLEMENTPlacebo

Toothpaste not containing the vitamin.

DIETARY_SUPPLEMENTCyanocobalamin

Toothpaste containing100 µg cyanocobalamin/g.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Yes

Inclusion criteria

* Adults: men and women * Stable diet for at least 24 months (omnivorous or a vegan diet).

Exclusion criteria

* Pregnancy and lactation * Malabsorption disorders (Crohn disease, chronic gastritis, pernicious anemia, gastric or intestinal resection) * Renal diseases * Liver diseases * Patients with cancer (or cancer history) * Pre-study treatment with vitamin B12 or folate

Design outcomes

Primary

Measure	Time frame	Description
The change in plasma concentrations of methylmalonic acid	Baseline, 3 months	Lowering methylmalonic acid in the B12 arm compared with the placebo arm
The change in plasma concentrations of holotranscobalamin	Baseline, 3 months	The effect on increasing holotranscobalamin in the B12 arm compared with the placebo arm
The change in plasma concentrations of homocysteine	Baseline, 3 months	Lowering homocysteine in the B12 arm compared with the placebo arm
The change in plasma concentrations of vitamin B12	Baseline, 3 months	The effect on increasing plasma vitamin B12 in the B12 arm compared with the placebo arm

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 11, 2026