Effect of Toothpaste Fortified With Cyanocobalamin on Vitamin B12 Status

Cobalamin Deficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02679833
• Other study ID #: B12 status after toothpaste
• Status: Completed
• Phase: N/A
• Start date: November 2014
• Est. completion date: December 2015

Study information

• Verified date: May 2018
• Source: Saarland University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Cobalamin Deficiency
• Vitamin B 12 Deficiency

Intervention

Dietary Supplement:
• Placebo
Toothpaste not containing the vitamin.
• Cyanocobalamin
Toothpaste containing100 µg cyanocobalamin/g.

Locations

Country	Name	City	State
Germany	Institute of Alternative and Sustainable Nutrition	Giessen
Germany	University of Saarland	Homburg	Saarland

Sponsors (2)

Lead Sponsor	Collaborator
Saarland University	Institute of Alternative and Sustainable Nutrition (IFANE)

Country where clinical trial is conducted

Germany, 

Outcome

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