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Effect of Toothpaste Fortified With Cyanocobalamin on Vitamin B12 Status

Primary Purpose

Cobalamin Deficiency

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Placebo
Cyanocobalamin
Sponsored by
Universität des Saarlandes
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cobalamin Deficiency focused on measuring Cobalamin biomarkers, Anemia, Vegan diet, Subclinical, Metabolic functional markers, Holotranscobalamin, Methylmalonic acid

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Saarland
  • Institute of Alternative and Sustainable Nutrition

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo

Cyanocobalamin

Arm Description

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

A toothpaste with cyanocobalamin 100 µg cyanocobalamin per 1 g.

Outcomes

Primary Outcome Measures

The change in plasma concentrations of methylmalonic acid
Lowering methylmalonic acid in the B12 arm compared with the placebo arm
The change in plasma concentrations of holotranscobalamin
The effect on increasing holotranscobalamin in the B12 arm compared with the placebo arm
The change in plasma concentrations of homocysteine
Lowering homocysteine in the B12 arm compared with the placebo arm
The change in plasma concentrations of vitamin B12
The effect on increasing plasma vitamin B12 in the B12 arm compared with the placebo arm

Secondary Outcome Measures

Full Information

First Posted
February 8, 2016
Last Updated
May 7, 2018
Sponsor
Universität des Saarlandes
Collaborators
Institute of Alternative and Sustainable Nutrition (IFANE)
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1. Study Identification

Unique Protocol Identification Number
NCT02679833
Brief Title
Effect of Toothpaste Fortified With Cyanocobalamin on Vitamin B12 Status
Official Title
Effect of Toothpaste Fortified With Cyanocobalamin on Vitamin B12 Status: A 3 Month Placebo Controlled Randomized Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
November 2014 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universität des Saarlandes
Collaborators
Institute of Alternative and Sustainable Nutrition (IFANE)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cobalamin Deficiency
Keywords
Cobalamin biomarkers, Anemia, Vegan diet, Subclinical, Metabolic functional markers, Holotranscobalamin, Methylmalonic acid

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
180 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
A toothpaste, with the same matrix, all components, and appearance like the active arm but not containing vitamin B12.
Arm Title
Cyanocobalamin
Arm Type
Active Comparator
Arm Description
A toothpaste with cyanocobalamin 100 µg cyanocobalamin per 1 g.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Toothpaste not containing the vitamin.
Intervention Type
Dietary Supplement
Intervention Name(s)
Cyanocobalamin
Intervention Description
Toothpaste containing100 µg cyanocobalamin/g.
Primary Outcome Measure Information:
Title
The change in plasma concentrations of methylmalonic acid
Description
Lowering methylmalonic acid in the B12 arm compared with the placebo arm
Time Frame
Baseline, 3 months
Title
The change in plasma concentrations of holotranscobalamin
Description
The effect on increasing holotranscobalamin in the B12 arm compared with the placebo arm
Time Frame
Baseline, 3 months
Title
The change in plasma concentrations of homocysteine
Description
Lowering homocysteine in the B12 arm compared with the placebo arm
Time Frame
Baseline, 3 months
Title
The change in plasma concentrations of vitamin B12
Description
The effect on increasing plasma vitamin B12 in the B12 arm compared with the placebo arm
Time Frame
Baseline, 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Markus Keller, PhD
Organizational Affiliation
Institute of Alternative and Sustainable Nutrition, Giessen, Germany
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Rima Obeid, PhD
Organizational Affiliation
Saarland University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
University of Saarland
City
Homburg
State/Province
Saarland
ZIP/Postal Code
66421
Country
Germany
Facility Name
Institute of Alternative and Sustainable Nutrition
City
Giessen
ZIP/Postal Code
35444
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Data sharing only between the two responsible study centers in a coded form, where participant ID is not shared.
Citations:
PubMed Identifier
30680547
Citation
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.
Results Reference
derived
PubMed Identifier
28052884
Citation
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.
Results Reference
derived

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Effect of Toothpaste Fortified With Cyanocobalamin on Vitamin B12 Status

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