Effect of Toothpaste Fortified With Cyanocobalamin on Vitamin B12 Status

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-30

Study Completion Date

2015-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Cobalamin Deficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Toothpaste not containing the vitamin.

Cyanocobalamin

A toothpaste with cyanocobalamin 100 µg cyanocobalamin per 1 g.

Group Type ACTIVE_COMPARATOR

Cyanocobalamin

Intervention Type DIETARY_SUPPLEMENT

Toothpaste containing100 µg cyanocobalamin/g.

Interventions

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Placebo

Toothpaste not containing the vitamin.

Intervention Type DIETARY_SUPPLEMENT

Cyanocobalamin

Toothpaste containing100 µg cyanocobalamin/g.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes