Published in
BioMed Central, BMC Public Health, 1(12), 2012
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Oral versus intramuscular administration of vitamin B12 for the treatment of patients with vitamin B12 deficiency: a pragmatic, randomised, multicentre, non-inferiority clinical trial undertaken in the primary healthcare setting (Project OB12)
,
Jesús MartÃn-Fernã¡ndez,
Francisco RodrÃguez-Salvanã©s,
Marta GarcÃa-Solano,
Jesús Martín-Fernández,
RocÃo González-Gonzã¡lez,
Esperanza Escortell-Mayor,
Francisco Rodríguez-Salvanés,
MarÃa Ã�ngeles MartÃn-De la Sierra-San AgustÃn,
M. García-Solano,
Carmen Olmedo-Lucerã³n
and other authors.
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Abstract
Abstract Background The oral administration of vitamin B12 offers a potentially simpler and cheaper alternative to parenteral administration, but its effectiveness has not been definitively demonstrated. The following protocol was designed to compare the effectiveness of orally and intramuscularly administered vitamin B12 in the treatment of patients ≥65 years of age with vitamin B12 deficiency. Methods/design The proposed study involves a controlled, randomised, multicentre, parallel, non-inferiority clinical trial lasting one year, involving 23 primary healthcare centres in the Madrid region (Spain), and patients ≥65 years of age. The minimum number of patients required for the study was calculated as 320 (160 in each arm). Bearing in mind an estimated 8-10% prevalence of vitamin B12 deficiency among the population of this age group, an initial sample of 3556 patients will need to be recruited. Eligible patients will be randomly assigned to one of the two treatment .