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| Name | Class |
|---|---|
| Institute of Alternative and Sustainable Nutrition (IFANE) | UNKNOWN |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | A toothpaste, with the same matrix, all components, and appearance like the active arm but not containing vitamin B12. |
|
| Cyanocobalamin | Active Comparator | A toothpaste with cyanocobalamin 100 µg cyanocobalamin per 1 g. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Dietary Supplement | Toothpaste not containing the vitamin. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Markus Keller, PhD | Institute of Alternative and Sustainable Nutrition, Giessen, Germany | Study Chair |
| Rima Obeid, PhD | Saarland University Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Saarland | Homburg | Saarland | 66421 | Germany | ||
| Institute of Alternative and Sustainable Nutrition |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30680547 | Derived | 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. | |
| 28052884 | Derived | 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. |
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Data sharing only between the two responsible study centers in a coded form, where participant ID is not shared.
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| ID | Term |
|---|---|
| D014806 | Vitamin B 12 Deficiency |
| D000740 | Anemia |
| ID | Term |
|---|---|
| D014804 | Vitamin B Deficiency |
| D001361 | Avitaminosis |
| D003677 | Deficiency Diseases |
| D044342 | Malnutrition |
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| ID | Term |
|---|---|
| D014805 | Vitamin B 12 |
| ID | Term |
|---|---|
| D045728 | Corrinoids |
| D045725 | Tetrapyrroles |
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 |
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| Cyanocobalamin |
| Dietary Supplement |
Toothpaste containing100 µg cyanocobalamin/g. |
|
| Giessen |
| 35444 |
| Germany |
| D009748 |
| Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |