Oral versus intramuscular administration of vitamin B12 for vitamin B12 deficiency in primary care: a pragmatic, randomised, non-inferiority clinical trial (OB12).

ABSTRACT:

Objectives

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 les

SUBMITTER: Sanz-Cuesta T 

PROVIDER: S-EPMC7440823 | biostudies-literature | 2020 Aug

REPOSITORIES: biostudies-literature