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The trial protocol was approved by the Madrid Region Clinical Research Ethics Committee ( Comit tico de Investigacin Clnica Regional de la Comunidad de Madrid ) on February 8 th 2011, and has been registered with ClinicalTrials.gov number NCT 01476007, and under EUDRACT number 2010-024129-20 [Oral Versus Intramuscular Cobalamin to treat Cobalamin Deficiency: Noninferiority randomised controlled trial, pragmatic and multi-center in the primary healthcare setting (OB12 project)]

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[42] Low maternal vitamin B 12 , defined as serum concentration less than 148 pmol/L, increases the risk of miscarriage, preterm birth and newborn low birth weight