Vitamin B12 in a Toothpaste: 92 Adults, Three Months
103 people were randomized to a toothpaste with vitamin B12 in it or an identical one without, and 92 were analyzed three months later. The vitamin group ended at 368 pmol/L of serum B12 against 295 in the placebo group, which the authors report at p = 0.005.
The abstract reports no measured per-person dose. The authors worked backwards from the blood instead, which is itself the tell.
THE STUDY
- Title: Vitamin B12-fortified toothpaste improves vitamin status in elderly people: a randomized, double-blind, placebo-controlled study
- Journal: Aging Clinical and Experimental Research, 2019, volume 31, issue 12, pages 1817 to 1825
- Authors: Zant A, Awwad HM, Geisel J, Keller M, Obeid R, from the Department of Clinical Chemistry and Laboratory Medicine at Saarland University Hospital in Homburg, Germany
- Design: Randomized, placebo controlled trial, indexed by PubMed as a Randomized Controlled Trial. Registered at ClinicalTrials.gov as NCT02679833. See the note on blinding below
- Read it: PubMed 30680547
WHO WAS IN IT
103 people were randomized and 92 were analyzed. The abstract does not print how many went into each group, so we cannot tell you the split. It describes them as elderly subjects. The registration describes the eligible group differently, as adults aged 18 to 75, men and women, and records them as healthy volunteers.
To take part you had to have eaten a stable diet for at least 24 months, either omnivorous or vegan. The registration excludes pregnancy and lactation, malabsorption disorders including Crohn disease, chronic gastritis, pernicious anemia and gastric or intestinal resection, along with renal disease, liver disease, cancer or a cancer history, and any pre-study treatment with vitamin B12 or folate.
No blood level was an entry requirement. Worth knowing both halves here: the registration files the trial under the condition heading Cobalamin Deficiency and lists its primary purpose as prevention, which sounds like a patient group. The eligibility criteria set no deficiency threshold to get in. So the heading describes what the trial was aimed at preventing, not who was recruited.
WHAT THEY TOOK
A toothpaste containing 100 micrograms of cyanocobalamin per gram, against a placebo toothpaste the registration describes as having the same matrix, all the same components and the same appearance, without the vitamin B12. People used it for three months.
The toothpaste itself was administered for three months at a stated concentration. What the abstract never prints is how much B12 any individual actually took in. The authors worked backwards from the blood results instead, writing that the 23% mean rise in serum B12 "suggests that the intervention had provided an additional daily intake of approximately + 7 µg oral B12." That word suggests is theirs. The seven micrograms is an estimate derived from the outcome, which means it cannot then be offered as the cause of that outcome. It is a description of the result in different units.
WHAT THEY FOUND
All the pairs below are mean (SD), vitamin group first, as the abstract prints them.
- Serum B12 ended higher in the vitamin group: 368 (123) against 295 (123) pmol/L, p = 0.005
- The change in serum B12 separated clearly: a rise of 54 (74) pmol/L against 3 (60) in the placebo group, p < 0.001. That is the 23% figure
- The change in holotranscobalamin, the active fraction, also separated: up 21 (34) against 2 (32) pmol/L, p = 0.007
- But holotranscobalamin at the end of the study did not. 112 (48) against 91 (68) pmol/L, p = 0.088. The authors say it "tended to be higher", and that is the right way to read a p of 0.088
- Homocysteine fell a little: a change of -0.9 (2.3) against 0.3 (1.9) µmol/L, p = 0.010
- On safety, the authors write that "No side effects were observed", and that "Common diseases and drugs did not predict the change of blood markers in the vitamin group"
WHAT IT DOES NOT SHOW
- The registered primary outcome is missing from the abstract. The registration names the change in plasma methylmalonic acid as the primary outcome variable. The registration groups methylmalonic acid with the metabolic functional markers, and lists it first among the primary outcomes. The abstract lists it in the methods, reports results for the three other registered outcomes, and prints no result for that one. We read the abstract and the records, not the full nine page paper, so we are not telling you the paper omits it. We are telling you the abstract does
- The paper and its own registration disagree on the blinding. The paper's title and abstract say double blind, and PubMed's indexing carries the Double-Blind Method tag. The ClinicalTrials.gov record lists masking as single, with the participant masked. We are not picking a side. We are telling you the two records do not match
- They disagree on the headcount too. The registration reports 180 people actually enrolled. The paper reports 103 randomized and 92 analyzed. Nothing in the abstract explains the gap
- And on the age. The paper calls them elderly. The registration sets the eligible range at 18 to 75 years. Those are not the same group, and the abstract does not print the ages of the people who actually took part
- It was registered after it finished. The trial ran from November 2014 to December 2015. The registration was first submitted in February 2016. Registering a trial in advance is what stops the outcomes being chosen after the results are in, and the registration shows that did not happen with this one
- Three months, 92 people. Short, and small. It shows blood markers moving, not health outcomes. Nothing here measures energy, thinking, nerves or how anyone felt
- This is not our product and not our form. It is cyanocobalamin in a toothpaste. Ours is methylcobalamin in a gummy you chew and swallow. A result from one delivery route is not a result for another
- Funding and conflicts are not stated. The PubMed record carries no funding statement and no conflict of interest statement at all. The registration lists Universität des Saarlandes as sponsor with the Institute of Alternative and Sustainable Nutrition as collaborator. No toothpaste manufacturer is named in either record, and we cannot tell you who supplied the product
WHY IT IS ON THIS SHELF
Because of how the number in the headline was made. The abstract reports no measured per-person intake anywhere. The researchers read the blood afterwards and converted the rise into an estimated daily intake, which means the seven micrograms describes the result rather than explaining it. Once you have seen that move you will start noticing it.
It belongs next to something this shelf has posted before. Fortified is not the same as absorbed made the point that what goes into a product and what reaches your blood are two different numbers. This trial runs that problem in reverse, reading the blood and inferring the intake, and it lands on the same honest answer: the amount on a label and the amount in a person are not the same question.
Each four gummy serving of Vybrance Labs creatine gummies carries 120mcg of vitamin B12 as methylcobalamin, alongside 5g of creatine monohydrate and 500mg of taurine. This trial tested a toothpaste, not a gummy, and not our formula, so it is not evidence about what ours does to anyone's B12 markers.
The Lab covers who tends to run low in vegan or vegetarian? you may be running low on creatine and B12.
see you in the wild!
-Lawrence
These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease. Nothing on this page is medical advice. Reference: PMID 30680547, DOI 10.1007/s40520-019-01125-6.
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Creatine first: a full 5g, with B12 and taurine alongside. Four gummies. Built for your whole day, not just your workout.