Ayman Zant1, Hussain M Awwad1, Jürgen Geisel1, Markus Keller2,3, Rima Obeid4,5. 1. Department of Clinical Chemistry and Laboratory Medicine, Saarland University Hospital, Building 57, 66421, Homburg, Saar, Germany. 2. Fachhochschule des Mittelstands, University of Applied Sciences, 50674, Cologne, Germany. 3. Institute of Alternative and Sustainable Nutrition, 35444, Biebertal, Giessen, Germany. 4. Department of Clinical Chemistry and Laboratory Medicine, Saarland University Hospital, Building 57, 66421, Homburg, Saar, Germany. rima.obeid@uks.eu. 5. Aarhus Institute of Advanced Studies, Aarhus University, 8000, Aarhus C, Denmark. rima.obeid@uks.eu.
Abstract
BACKGROUND:Elderly people are at risk for vitamin B12 deficiency. AIMS: We studied the ability of vitamin B12-enriched toothpaste vs. placebo to increase vitamin B12 status in elderly subjects. METHODS: We conducted a randomized double-blind placebo-controlled intervention in 103 elderly subjects. Serum concentrations of vitamin B12, holotranscobalamin (holoTC), methylmalonic acid (MMA), and plasma total homocysteine (tHcy) were measured at baseline and after 3 months. RESULTS:92 subjects met the inclusion criteria, completed the 3 months study, and were included in the data analysis. After the intervention, concentrations of vitamin B12 were higher [mean (SD) = 368 (123) vs. 295 (123) pmol/L; p = 0.005] and holoTC tended to be higher [112 (48) vs. 91 (68) pmol/L; p = 0.088] in the vitamin B12 group compared with the placebo group. The changes of serum vitamin B12 [54 (74) vs. 3 (60) pmol/L, p < 0.001], holoTC [21 (34) vs. 2 (32) pmol/L, p = 0.007], and tHcy [- 0.9 (2.3) vs. 0.3 (1.9) µmol/L, p = 0.010] were significantly different between the intervention groups. Mean percentage increase of serum vitamin B12 (+ 23% corresponds to + 54 pmol/L) in the vitamin B12 toothpaste group suggests that the intervention had provided an additional daily intake of approximately + 7 µg oral B12. Common diseases and drugs did not predict the change of blood markers in the vitamin group. No side effects were observed. CONCLUSIONS: The toothpaste enriched with 100 µg cyanocobalamin/g has increased vitamin B12 status and can thus be used for preventing vitamin B12 depletion in elderly people. The trial was registered at ClinicalTrials.gov: NCT02679833.
RCT Entities:
BACKGROUND: Elderly people are at risk for vitamin B12 deficiency. AIMS: We studied the ability of vitamin B12-enriched toothpaste vs. placebo to increase vitamin B12 status in elderly subjects. METHODS: We conducted a randomized double-blind placebo-controlled intervention in 103 elderly subjects. Serum concentrations of vitamin B12, holotranscobalamin (holoTC), methylmalonic acid (MMA), and plasma total homocysteine (tHcy) were measured at baseline and after 3 months. RESULTS: 92 subjects met the inclusion criteria, completed the 3 months study, and were included in the data analysis. After the intervention, concentrations of vitamin B12 were higher [mean (SD) = 368 (123) vs. 295 (123) pmol/L; p = 0.005] and holoTC tended to be higher [112 (48) vs. 91 (68) pmol/L; p = 0.088] in the vitamin B12 group compared with the placebo group. The changes of serum vitamin B12 [54 (74) vs. 3 (60) pmol/L, p < 0.001], holoTC [21 (34) vs. 2 (32) pmol/L, p = 0.007], and tHcy [- 0.9 (2.3) vs. 0.3 (1.9) µmol/L, p = 0.010] were significantly different between the intervention groups. Mean percentage increase of serum vitamin B12 (+ 23% corresponds to + 54 pmol/L) in the vitamin B12 toothpaste group suggests that the intervention had provided an additional daily intake of approximately + 7 µg oral B12. Common diseases and drugs did not predict the change of blood markers in the vitamin group. No side effects were observed. CONCLUSIONS: The toothpaste enriched with 100 µg cyanocobalamin/g has increased vitamin B12 status and can thus be used for preventing vitamin B12 depletion in elderly people. The trial was registered at ClinicalTrials.gov: NCT02679833.