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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
180
Toothpaste not containing the vitamin.
Toothpaste containing100 µg cyanocobalamin/g.
University of Saarland
Homburg, Saarland, Germany
Institute of Alternative and Sustainable Nutrition
Giessen, Germany
The change in plasma concentrations of methylmalonic acid
Lowering methylmalonic acid in the B12 arm compared with the placebo arm
Time frame: Baseline, 3 months
The change in plasma concentrations of holotranscobalamin
The effect on increasing holotranscobalamin in the B12 arm compared with the placebo arm
Time frame: Baseline, 3 months
The change in plasma concentrations of homocysteine
Lowering homocysteine in the B12 arm compared with the placebo arm
Time frame: 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
Time frame: Baseline, 3 months
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