Effect of Toothpaste Fortified With Cyanocobalamin on Vitamin B12 Status

May 7, 2018 updated by: Rima Obeid, Universität des Saarlandes

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

180

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Giessen, Germany, 35444
        • Institute of Alternative and Sustainable Nutrition
    • Saarland
      • Homburg, Saarland, Germany, 66421
        • University of Saarland

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
A toothpaste, with the same matrix, all components, and appearance like the active arm but not containing vitamin B12.
Dietary supplement: Placebo
Toothpaste not containing the vitamin.
Active Comparator: Cyanocobalamin
A toothpaste with cyanocobalamin 100 µg cyanocobalamin per 1 g.
Dietary supplement: Cyanocobalamin
Toothpaste containing100 µg cyanocobalamin/g.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universität des Saarlandes

Collaborators

Institute of Alternative and Sustainable Nutrition (IFANE)

Investigators

  • Study Chair: Markus Keller, PhD, Institute of Alternative and Sustainable Nutrition, Giessen, Germany
  • Study Director: Rima Obeid, PhD, Saarland University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2014

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

February 8, 2016

First Submitted That Met QC Criteria

February 9, 2016

First Posted (Estimate)

February 10, 2016

Study Record Updates

Last Update Posted (Actual)

May 11, 2018

Last Update Submitted That Met QC Criteria

May 7, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B12 status after toothpaste

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Data sharing only between the two responsible study centers in a coded form, where participant ID is not shared.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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