Oral versus intramuscular administration of vitamin B12 for vitamin B12 deficiency in primary care: a pragmatic, randomised, non-inferiority clinical trial (OB12)
Sanz-Cuesta T, Escortell-Mayor E, Cura-Gonzalez I, Martin-Fernandez J, Riesgo-Fuertes R, Garrido-Elustondo S, et al.
Published in BMJ Open, Vol. 10 (8), pp. e033687
Methodology
Pragmatic, randomised, non-inferiority, open-label trial in 22 primary care centres in Madrid of oral (1 mg/day for 8 weeks, then weekly) versus intramuscular B12 in adults aged 65 or older with deficiency.
Key Findings
At 8 weeks, more than 90% in each arm had normal serum B12. At 52 weeks, 73.6% (oral) vs 80.4% (IM) had normal levels in the per-protocol analysis; non-inferiority at 52 weeks was not shown. 83.4% preferred the oral route.
Conclusions
Oral B12 was no less effective at 8 weeks; the 52-week difference means long-term oral dosing needs monitoring.
Limitations
Open-label; 19% did not complete follow-up; serum B12 was the main outcome, not symptoms.
Related Health Concerns
Study Details
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