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2 INSERM U 258, Hôpital Paul Brousse, Villejuif, France; 3 Biochimie, hôpital Necker, Paris; 4 Biochimie, hôpital Emile Roux, Limeil-Brévannes, France; 5 Hématologie Biologique, hôpital Henri Mondor, Créteil, France; 6 Agence Générale des Equipements et Produits de Santé, Paris, France; 7 Médecine Gériatrique, hôpital Emile Roux, Limeil-Brévannes, France; 8 Pharmacie, hôpital Emile Roux, Limeil-Brévannes, France; and 9 Santé Publique, hôpital Georges Pompidou, Paris, France
* To whom correspondence should be addressed. E-mail: jacques.blacher{at}htd.aphp.fr.
The BOSSANOVA study, a randomized double-blind trial, was designed to test the ability of very low oral doses of vitamin B-12 to increase the serum vitamin B-12 concentration in elderly subjects with food-bound vitamin B-12 malabsorption, and to determine whether there was a dose response. We also aimed to quantitatively assess the most efficient dose to be added to flour in addition to folic acid (flour cofortification with vitamin B-12 and folic acid). Sixty-seven patients were randomly assigned to 1 of 6 groups receiving various daily oral doses of vitamin B-12 (i.e., 2.5, 5, 10, 20, 40, or 80 µg/d) for 30 d. The dose-response was tested for different biological variables using a mixed model, taking into account the variable's initial value (between-subject effect), a linear log-dose effect, and a linear log (dose x time) interaction, where time was d 15 or d 30. We planned to determine the amount of oral vitamin B-12 that would increase the serum vitamin B-12 concentration by 37 pmol/L (50 ng/L). Significant between-subject effects were found for serum vitamin B-12, plasma homocysteine, and methylmalonic acid concentrations, but a log-dose effect was found only for vitamin B-12 (P < 0.001). The slope of the line tended to be higher (P = 0.07) at d 30 than at d 15. For a mean serum vitamin B-12 increase of 37 pmol/L, a dose of 5.9 (95% CI, 0.9–12.1) µg/d was needed. We concluded that very low oral doses of vitamin B-12 increased serum vitamin B-12 concentrations in elderly subjects with subclinical vitamin B-12 deficiency, following a log-dose pattern. Our results could be beneficial in the design of a public health program for safe flour cofortification with folic acid.
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