Effect of Toothpaste Fortified With Cyanocobalamin on Vitamin B12 Status

Universität des Saarlandes

Status: Completed

Conditions: Cobalamin Deficiency

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Cyanocobalamin

Study type: Interventional

Funder types: Other

Identifiers

NCT02679833

B12 status after toothpaste

Details and patient eligibility

About

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.

Enrollment: 180 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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180 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Placebo

Cyanocobalamin

Active Comparator group

Description:

A toothpaste with cyanocobalamin 100 µg cyanocobalamin per 1 g.

Treatment:

Dietary Supplement: Cyanocobalamin