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Completed

NCT Number: NCT02679833

Effect of Toothpaste Fortified With Cyanocobalamin on Vitamin B12 Status

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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Key information

Conditions

Cobalamin Deficiency Anemia Avitaminosis Deficiency Diseases Hematologic Diseases Hemic and Lymphatic Diseases Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases Vitamin B 12 Deficiency Vitamin B Deficiency

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Saarland, Homburg, Saarland, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo

Dietary Supplement

Toothpaste not containing the vitamin.

cyanocobalamin

Dietary Supplement

Toothpaste containing100 µg cyanocobalamin/g.

Primary outcomes

  1. 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

  2. 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

  3. The change in plasma concentrations of homocysteine

    Time frame: Baseline, 3 months

    Lowering homocysteine in the B12 arm compared with the placebo arm

  4. 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

Sponsors and collaborators

Lead sponsor

Universität des Saarlandes

Other

Collaborators

  • Institute of Alternative and Sustainable Nutrition (IFANE)

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Feb 10, 2016
Registry last updated
May 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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