Oral/Intramuscular B12 to Treat Cobalamin Deficiency

Summary

Objective: To determine the effectiveness of oral versus intramuscular Cobalamin (vitamin B12) by restore cobalamin parameter in blood at 8, 26 and 52 weeks in ≥ 65 aged patients with Cobalamin Deficiency. Design: Noninferiority randomised controlled trial, pragmatic and multi-center in the primary healthcare setting (Madrid Region). Participants: ≥ 65 aged patients with Cobalamin Deficiency. Patients give inform consent. Number of patients: 320 (160 each arm). Assignment: randomized simple (automatic system). Variables. Main outcome variable: Cobalamin level standardization (yes/no). Secondary outcome variables: Adverse events. Adherence measurement of treatment. Health related quality of life questionnaire (Euroqol-5D). Satisfaction and preferences. Other variables: Gender. Age. Live alone. Vegetarian diet. Alcohols consume. Clinic Variables (symptoms and physical examination) and blood parameters. Drugs consume. Causes of all losses and withdrawals. Number of patients (age and gender) who declined to participate. All data (excluding patient identification data) will be record in an electronic database. Intervention group: oral Optovite® B12 1000 gammas. Control group: idem intramuscular. Analysis: Descriptive analysis (screening phase). Baseline comparison of the two intervention groups. Effect of cobalamin (main outcome variable). Security. Quality of life. Adherence measurement of treatment.

Timeline

Start

2014-07

Primary completion

2017-11-28

Completion

2017-11-28

Publications

• Background Sanz-Cuesta T, Gonzalez-Escobar P, Riesgo-Fuertes R, Garrido-Elustondo S, del Cura-Gonzalez I, Martin-Fernandez J, Escortell-Mayor E, Rodriguez-Salvanes F, Garcia-Solano M, Gonzalez-Gonzalez R, Martin-de la Sierra-San Agustin MA, Olmedo-Luceron C, Sevillano Palmero ML, Mateo-Ruiz C, Medina-Bustillo B, Valdivia-Perez A, Garcia-de Blas-Gonzalez F, Marino-Suarez JE, Rodriguez-Barrientos R, Ariza-Cardiel G, Cabello-Ballesteros LM, Polentinos-Castro E, Rico-Blazquez M, Rodriguez-Monje MT, Soto-Diaz S, Martin-Iglesias S, Rodriguez-Gonzalez R, Breton-Lesmes I, Vicente-Herrero M, Sanchez-Diaz J, Gomez-Gascon T, Drake-Canela M, Asunsolo-del Barco A; OB12 Group. 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). BMC Public Health. 2012 May 31;12:394. doi: 10.1186/1471-2458-12-394.
• Sanz-Cuesta T, Escortell-Mayor E, Cura-Gonzalez I, Martin-Fernandez J, Riesgo-Fuertes R, Garrido-Elustondo S, Marino-Suarez JE, Alvarez-Villalba M, Gomez-Gascon T, Gonzalez-Garcia I, Gonzalez-Escobar P, Vargas-Machuca Cabanero C, Noguerol-Alvarez M, Garcia de Blas-Gonzalez F, Banos-Morras R, Diaz-Laso C, Caballero-Ramirez N, Herrero de-Dios A, Fernandez-Garcia R, Herrero-Hernandez J, Pose-Garcia B, Sevillano-Palmero ML, Mateo-Ruiz C, Medina-Bustillo B, Aguilar-Jimenez M; OB12 Group. Oral versus intramuscular administration of vitamin B12 for vitamin B12 deficiency in primary care: a pragmatic, randomised, non-inferiority clinical trial (OB12). BMJ Open. 2020 Aug 20;10(8):e033687. doi: 10.1136/bmjopen-2019-033687.

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