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BMC Public Health. 2012 May 31;12:394. doi: 10.1186/1471-2458-12-394.

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).

Collaborators (172)

Reviriego Jaén G, Montero García C, Sanz Lorente AI, Serrano Simarro Mdel P, Díaz Sánchez J, Ramos Gutiérrez IM, San Vicente Rodríguez JM, Huelin Martín P, González García MI, Camarero Shelly M, Reinares Martínez C, Villanova Cuadra L, Gómez del Forcallo RM, Endrino Gómez F, Ferreras Eleta MR, De Vicente Aymat L, Santander Gutiérrez MS, Mateo Madurga A, Caballero Ramírez N, Morán Escudero A, Rodríguez Franco M, Meiriño Pérez ML, Zamora Gómez MM, Vivas Rubio F, Martín Martín M, Pérez Quero R, Manzano Martín MI, Pastor Sánchez R, Herrero de Dios A, Redondo Luciáñez C, Casado Rodríguez C, Andrés Arreaza LM, Hombrados Gonzalo P, Escolar Llamazares S, López Ortiz F, del Rey Moya LM, Rodríguez López I, Martín Acicoya D, Kloppe Villegas P, García Amor I, Canals Aracil M, Gómez Marco JJ, González Álvaro A, San Andrés Rebollo FJ, González López I, Herreros Hernanz I, Revuelta Alonso A, Calvo Arrabal N, Jimeno Galán MM, García Hernández R, Gómez Gascón T, Vargas-Machuca Cabañero C, Gutiérrez Sánchez MI, Fernández Abad MA, Beltejar Rodríguez M, Martínez Suberviola J, Real Pérez MA, Coello Alarcón C, San Andrés Pascua C, Granados Garrido JA, Machín Hamalainen S, Mateo Fernández R, de la Cámara Gonzalez C, Garcés Ranz JD, Prieto Orzanco A, Marín Becerra MT, Cubero González P, Abellán López FR, Álvarez Montes O, Canellas Manrique M, San Telesforo Navarro MJ, Parrilla Laso MM, Aragoneses Cañas MÁ, Auñón Muelas A, Valdés Cruz E, Mayoral Lopez C, Gijon Seco T, Martinez Vallejo F, Menéndez Fernández AI, De la Peña González Mdel M, Maroto García MÁ, Sánchez Cristóbal M, Álvarez Orviz MC, Herrero Hernández J, González Márquez MV, López Rodríguez MJ, Almarza García Mde L, San Clemente Pastor MT, Corral Rubio MÁ, Ruiz Zurita G, Allue Bergua Á, Cabrera Orozco M, De Antonio García Mdel P, Cerezo Diviu AI, Solsons Roig I, Gómez de Abia P, Díaz Laso MC, Asensio Ruiz ML, Siguero Pérez C, Molina Siguero A, Cerrada Puri I, Rodríguez Almagro P, Rosanes González R, Pérez García MC, Noguerol Álvarez M, de Miguel Abanto MÁ, Reyes Martínez ML, Gutiérrez Valentín P, Gómez Ciriano J, Calzada Benito R, Torrijos Bravo C, Ferreiro González D, León González J, Tomás García N, Alcalá Faúndez A, Fernández López E, Melero Redondo I, González Gascón R, Sánchez Yépez J, Fernández Girón Mdel P, López Serrano B, Rodríguez Monje MT, Morso Pelaez P, Cortes Duran M, López Olmeda C, García-Uceda Sevilla A, Serrano González D, Santamaría López I, García De Blas González F, López García-Franco A, Azcoaga Lorenzo A, Álvarez Villalba M, Pose García B, Fernández García R, de Alba Gómez F, Redondo Horcajo A, Pajuelo Márquez B, Gala Paniagua JL, Cidoncha Calderón E, Delgado Delgado Á, Gómez Martín MJ, Ávila Tomas JF, Mariño Suárez JE, Quintana Gómez JL, González-Posada Delgado JA, Revilla Pascual E, Duralde Rodríguez E, Beamud Lagos M, González Galán L, Verdugo Rosado M, Nistal Martín de Serranos L, López Barroso MJ, Rivera Moreno M, Torres Parras M, Delgado Pulpon MR, Alcalá Llorente E, Muñoz Moreno S, Ribao Verdugo AM, Fidalgo Baz MJ, Vaquero Turiño I, Fidalgo Baz AM, Sanz Sanchez C, Sánchez Sempere AM, Martínez Sanz J, Arratibel Elizondo MI, González Escobar P, Muñoz Gutiérrez J, Baños Morras R, Molins Santos C, Ibarra Sánchez AM, Gómez Almodóvar C, Cassinello Espinosa C.

Author information

1
Unidad de Apoyo a la Investigación, Gerencia Atención Primaria, Servicio Madrileño de Salud, Calle Espronceda 24, Madrid 28003, Spain. teresa.sanzcu@salud.madrid.org

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 arms. In the intramuscular treatment arm, vitamin B12 will be administered as follows: 1 mg on alternate days in weeks 1 and 2, 1 mg/week in weeks 3-8,and 1 mg/month in weeks 9-52. In the oral arm, the vitamin will be administered as: 1 mg/day in weeks 1-8 and 1 mg/week in weeks 9-52. The main outcome variable to be monitored in both treatment arms is the normalisation of the serum vitamin B12 concentration at weeks 8, 26 and 52; the secondary outcome variables include the serum concentration of vitamin B12 (in pg/ml), adherence to treatment, quality of life (EuroQoL-5D questionnaire), patient 3satisfaction and patient preferences. All statistical tests will be performed with intention to treat and per protocol. Logistic regression with random effects will be used to adjust for prognostic factors. Confounding factors or factors that might alter the effect recorded will be taken into account in analyses.

DISCUSSION:

The results of this study should help establish, taking quality of life into account, whether the oral administration of vitamin B12 is an effective alternative to its intramuscular administration. If this administration route is effective, it should provide a cheaper means of treating vitamin B12 deficiency while inducing fewer adverse effects. Having such an alternative would also allow patient preferences to be taken into consideration at the time of prescribing treatment.

TRIAL REGISTRATION:

This trial has been registered with ClinicalTrials.gov, number NCT 01476007, and under EUDRACT number 2010-024129-20.

PMID:
22650964
PMCID:
PMC3403849
DOI:
10.1186/1471-2458-12-394
[Indexed for MEDLINE]
Free PMC Article

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