Effect of Toothpaste Fortified With Cyanocobalamin on Vitamin B12 Status

Not Applicable

Completed

• Conditions: Cobalamin Deficiency
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: Cyanocobalamin

• Registration Number: NCT02679833
• Lead Sponsor: Universität des Saarlandes

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-11
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Study First Submitted: 2016-02-08
• Study First Submitted QC: 2016-02-09
• Study First Posted: 2016-02-10
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-07
• Last Update Posted: 2018-05-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	A toothpaste, with the same matrix, all components, and appearance like the active arm but not containing vitamin B12.
Cyanocobalamin	Cyanocobalamin	A toothpaste with cyanocobalamin 100 µg cyanocobalamin per 1 g.

Primary Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (2)

University of Saarland; 🇩🇪 Homburg, Saarland, Germany

Institute of Alternative and Sustainable Nutrition; 🇩🇪 Giessen, Germany