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dc.contributor.authorSanz-Cuesta, Teresa
dc.contributor.authorEscortell-Mayor, Esperanza
dc.contributor.authorCura-Gonzalez, Isabel
dc.contributor.authorMartin-Fernandez, Jesus
dc.contributor.authorRiesgo-Fuertes, Rosario
dc.contributor.authorGarrido-Elustondo, Sofía
dc.contributor.authorMariño-Suárez, Jose Enrique
dc.contributor.authorÁlvarez-Villalba, Mar
dc.contributor.authorGómez-Gascón, Tomás
dc.contributor.authorGonzález-García, Inmaculada
dc.contributor.authorGonzález-Escobar, Paloma
dc.contributor.authorVargas-Machuca Cabañero, Concepción
dc.contributor.authorNoguerol-Álvarez, Mar
dc.contributor.authorGarcía de Blas-González, Francisca
dc.contributor.authorBaños-Morras, Raquel
dc.contributor.authorDíaz-Laso, Concepción
dc.contributor.authorCaballero-Ramírez, Nuria
dc.contributor.authorHerrero de-Dios, Alicia
dc.contributor.authorFernández-García, Rosa
dc.contributor.authorHerrero-Hernández, Jesús
dc.contributor.authorPose-García, Belen
dc.contributor.authorSevillano-Palmero, María Luisa
dc.contributor.authorMateo-Ruiz, Carmen
dc.contributor.authorMedina-Bustillo, Beatriz
dc.contributor.authorAguilar-Jiménez, Monica
dc.contributor.authorOB12 Group
dc.contributor.authorAzcoaga-Lorenzo, Amaya
dc.date.accessioned2020-08-25T12:30:01Z
dc.date.available2020-08-25T12:30:01Z
dc.date.issued2020-08-20
dc.identifier.citationSanz-Cuesta , T , Escortell-Mayor , E , Cura-Gonzalez , I , Martin-Fernandez , J , Riesgo-Fuertes , R , Garrido-Elustondo , S , Mariño-Suárez , J E , Álvarez-Villalba , M , Gómez-Gascón , T , González-García , I , González-Escobar , P , Vargas-Machuca Cabañero , C , Noguerol-Álvarez , M , García de Blas-González , F , Baños-Morras , R , Díaz-Laso , C , Caballero-Ramírez , N , Herrero de-Dios , A , Fernández-García , R , Herrero-Hernández , J , Pose-García , B , Sevillano-Palmero , M L , Mateo-Ruiz , C , Medina-Bustillo , B , Aguilar-Jiménez , M , OB12 Group & Azcoaga-Lorenzo , A 2020 , ' Oral versus intramuscular administration of vitamin B12 for vitamin B12 deficiency in primary care : a pragmatic, randomised, non-inferiority clinical trial (OB12) ' , BMJ Open , vol. 10 , no. 8 , e033687 . https://doi.org/10.1136/bmjopen-2019-033687en
dc.identifier.issn2044-6055
dc.identifier.otherPURE: 269783232
dc.identifier.otherPURE UUID: 99771fd4-5bcf-456a-9edc-8d6cdcce68c7
dc.identifier.otherORCID: /0000-0003-3307-878X/work/79565050
dc.identifier.otherScopus: 85089769686
dc.identifier.urihttps://hdl.handle.net/10023/20511
dc.descriptionThe trial was financed by Ministerio de Sanidad y Consumo Español through their call for independent clinical research, Orden Ministerial SAS/2377, 2010 (EC10-115, EC10-116, EC10-117, EC10-119, EC10-122); CAIBER—Spanish Clinical Research Network, Instituto de Salud Carlos III (ISCIII) (CAI08/010044); and Gerencia Asistencial de Atención Primaria de Madrid. This study is also supported by the Spanish Clinical Research Network (SCReN), funded by ISCIII-Subdirección General de Evaluación y Fomento de la Investigación, project number PT13/0002/0007, within the National Research Program I+D+I 2013-2016 and co-funded with European Union ERDF funds (European Regional Development Fund). This project received a grant for the translation and publication of this article from the Foundation for Biomedical Research and Innovation in Primary Care (FIIBAP) Call 2017 for grants to promote research programs.en
dc.description.abstractObjectives To compare the effectiveness of oral versus intramuscular (IM) vitamin B12 (VB12) in patients aged ≥65 years with VB12 deficiency. Design Pragmatic, randomised, non-inferiority, multicentre trial in 22 primary healthcare centres in Madrid (Spain). Participants 283 patients ≥65 years with VB12 deficiency were randomly assigned to oral (n=140) or IM (n=143) treatment arm. Interventions The IM arm received 1 mg VB12 on alternate days in weeks 1–2, 1 mg/week in weeks 3–8 and 1 mg/month in weeks 9–52. The oral arm received 1 mg/day in weeks 1–8 and 1 mg/week in weeks 9–52. Main outcomes Serum VB12 concentration normalisation (≥211 pg/mL) at 8, 26 and 52 weeks. Non-inferiority would be declared if the difference between arms is 10% or less. Secondary outcomes included symptoms, adverse events, adherence to treatment, quality of life, patient preferences and satisfaction. Results The follow-up period (52 weeks) was completed by 229 patients (80.9%). At week 8, the percentage of patients in each arm who achieved normal B12 levels was well above 90%; the differences in this percentage between the oral and IM arm were −0.7% (133 out of 135 vs 129 out of 130; 95% CI: −3.2 to 1.8; p>0.999) by per-protocol (PPT) analysis and 4.8% (133 out of 140 vs 129 out of 143; 95% CI: −1.3 to 10.9; p=0.124) by intention-to-treat (ITT) analysis. At week 52, the percentage of patients who achieved normal B12 levels was 73.6% in the oral arm and 80.4% in the IM arm; these differences were −6.3% (103 out of 112 vs 115 out of 117; 95% CI: −11.9 to −0.1; p=0.025) and −6.8% (103 out of 140 vs 115 out of 143; 95% CI: −16.6 to 2.9; p=0.171), respectively. Factors affecting the success rate at week 52 were age, OR=0.95 (95% CI: 0.91 to 0.99) and having reached VB12 levels ≥281 pg/mL at week 8, OR=8.1 (95% CI: 2.4 to 27.3). Under a Bayesian framework, non-inferiority probabilities (Δ>−10%) at week 52 were 0.036 (PPT) and 0.060 (ITT). Quality of life and adverse effects were comparable across groups. 83.4% of patients preferred the oral route. Conclusions Oral administration was no less effective than IM administration at 8 weeks. Although differences were found between administration routes at week 52, the probability that the differences were below the non-inferiority threshold was very low.
dc.format.extent11
dc.language.isoeng
dc.relation.ispartofBMJ Openen
dc.rightsCopyright © Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. http://creativecommons.org/licenses/by-nc/4.0/This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.en
dc.subjectRA0421 Public health. Hygiene. Preventive Medicineen
dc.subjectNDASen
dc.subjectSDG 3 - Good Health and Well-beingen
dc.subject.lccRA0421en
dc.titleOral versus intramuscular administration of vitamin B12 for vitamin B12 deficiency in primary care : a pragmatic, randomised, non-inferiority clinical trial (OB12)en
dc.typeJournal articleen
dc.description.versionPublisher PDFen
dc.contributor.institutionUniversity of St Andrews. School of Medicineen
dc.contributor.institutionUniversity of St Andrews. Population and Behavioural Science Divisionen
dc.identifier.doihttps://doi.org/10.1136/bmjopen-2019-033687
dc.description.statusPeer revieweden


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