NCT02679833

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2014

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2014

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 8, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 10, 2016

Completed
Last Updated

May 11, 2018

Status Verified

May 1, 2018

Enrollment Period

1.1 years

First QC Date

February 8, 2016

Last Update Submit

May 7, 2018

Conditions

Cobalamin Deficiency

Keywords

Cobalamin biomarkersAnemiaVegan dietSubclinicalMetabolic functional markersHolotranscobalaminMethylmalonic acid

Outcome Measures

Primary Outcomes (4)

  • The change in plasma concentrations of methylmalonic acid

    Lowering methylmalonic acid in the B12 arm compared with the placebo arm

    Baseline, 3 months

  • The change in plasma concentrations of holotranscobalamin

    The effect on increasing holotranscobalamin in the B12 arm compared with the placebo arm

    Baseline, 3 months

  • The change in plasma concentrations of homocysteine

    Lowering homocysteine in the B12 arm compared with the placebo arm

    Baseline, 3 months

  • 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

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Cyanocobalamin

ACTIVE COMPARATOR

A toothpaste with cyanocobalamin 100 µg cyanocobalamin per 1 g.

Dietary Supplement: Cyanocobalamin

Interventions

PlaceboDIETARY_SUPPLEMENT

Toothpaste not containing the vitamin.

Placebo
CyanocobalaminDIETARY_SUPPLEMENT

Toothpaste containing100 µg cyanocobalamin/g.

Cyanocobalamin

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults: men and women
  • Stable diet for at least 24 months (omnivorous or a vegan diet).

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Saarland

Homburg, Saarland, 66421, Germany

Location

Institute of Alternative and Sustainable Nutrition

Giessen, 35444, Germany

Location

Related Publications (2)

  • Zant A, Awwad HM, Geisel J, Keller M, Obeid R. Vitamin B12-fortified toothpaste improves vitamin status in elderly people: a randomized, double-blind, placebo-controlled study. Aging Clin Exp Res. 2019 Dec;31(12):1817-1825. doi: 10.1007/s40520-019-01125-6. Epub 2019 Jan 24.

    PMID: 30680547DERIVED

  • Siebert AK, Obeid R, Weder S, Awwad HM, Sputtek A, Geisel J, Keller M. Vitamin B-12-fortified toothpaste improves vitamin status in vegans: a 12-wk randomized placebo-controlled study. Am J Clin Nutr. 2017 Mar;105(3):618-625. doi: 10.3945/ajcn.116.141978. Epub 2017 Jan 4.

    PMID: 28052884DERIVED

MeSH Terms

Conditions

Vitamin B 12 DeficiencyAnemia

Interventions

Vitamin B 12

Condition Hierarchy (Ancestors)

Vitamin B DeficiencyAvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic DiseasesHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

CorrinoidsTetrapyrrolesPyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingMacrocyclic CompoundsPolycyclic Compounds

Study Officials

  • Markus Keller, PhD

    Institute of Alternative and Sustainable Nutrition, Giessen, Germany

    STUDY CHAIR

  • Rima Obeid, PhD

    Saarland University Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

February 8, 2016

First Posted

February 10, 2016

Study Start

November 1, 2014

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

May 11, 2018

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will not share

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

Locations

DE(2)