The Effect of Daily Vitamin B-12 Supplementation on the Incidence of Common Childhood Infections in Nepal: Secondary Outcomes from a Double-Blind Randomized Controlled Trial.
Strand T, Chandyo R, et al. • The Journal of nutrition • 2026
Daily vitamin B-12 supplementation for 1 year in infants at risk of vitamin B-12 deficiency did not reduce the burden of common infections, with an incidence rate ratio for health clinic visits of 0.99 (95% CI: 0.85, 1.14).
Key Findings
Results
Vitamin B-12 supplementation had no statistically significant effect on health clinic visit incidence compared to placebo.
There were 1474 visits to health clinics in the vitamin B-12 group and 1498 in the placebo group.
The incidence rate ratio for clinic visits was 0.99 (95% CI: 0.85, 1.14).
The trial enrolled 600 infants aged 6-11 months randomized 1:1 to treatment or placebo.
The intervention period was 12 months with daily dosing.
Results
No statistically significant effect of vitamin B-12 supplementation was found on any of the 20 clinical infection outcomes measured.
The study recorded signs and symptoms of 20 common illnesses throughout the intervention period.
This was a predefined exploratory secondary analysis of a double-blind, placebo-controlled trial.
The trial was conducted in Bhaktapur, Nepal, in a population at risk of vitamin B-12 deficiency with prevalent childhood infections.
Methods
Trial retention and compliance were high, with only 26 children lost to follow-up and nearly 95% of scheduled doses taken.
Only 26 children out of 600 were lost to follow-up.
Almost 95% of scheduled daily vitamin B-12 doses or placebo were taken.
The community-based, individually randomized design was conducted in Bhaktapur, Nepal.
The dose used was 2 μg of vitamin B-12 daily.
Results
The study also reassessed the effect of supplementation on biomarker concentrations stratified by baseline vitamin B-12 status.
The reassessment of biomarker concentrations by baseline vitamin B-12 status was included in this report.
Primary and other key secondary outcomes including growth, neurodevelopment, cobalamin status, and hemoglobin concentration had been previously published.
The trial was registered at clinicaltrials.gov as NCT02272842.
Background
The study population was characterized by risk of vitamin B-12 deficiency and prevalent childhood infections, making it a relevant context for testing the supplementation hypothesis.
Infants were aged 6-11 months at enrollment and identified as being at risk of vitamin B-12 deficiency.
The study was conducted in Nepal, a setting with common childhood infections.
Vitamin B-12 deficiency is known to affect cell division and differentiation, erythropoiesis, and immune function, providing the biological rationale for the study.
What This Means
This research studied whether giving young infants in Nepal a daily vitamin B-12 supplement for one year would reduce how often they got sick. The study enrolled 600 babies aged 6 to 11 months who were at risk of having low vitamin B-12 levels — a common nutritional problem in this region. Half received a small daily dose of vitamin B-12 (2 micrograms) and half received a placebo (inactive pill), and neither the families nor the researchers knew which each child was getting. Researchers tracked clinic visits and signs of 20 different common illnesses over the year.
The results showed no meaningful difference between the two groups. Children in the vitamin B-12 group made 1,474 health clinic visits, while those in the placebo group made 1,498 — essentially the same rate. None of the 20 individual illness outcomes showed a statistically significant difference between groups. The study had very good participation, with nearly 95% of doses taken and very few children dropping out, meaning the results are reliable.
This research suggests that giving vitamin B-12 supplements to infants at risk of deficiency does not reduce their likelihood of getting common childhood infections, even in a setting where such deficiency and infections are widespread. This is notable because vitamin B-12 plays a role in immune function, so there was a reasonable scientific basis to expect a benefit. The findings add to previously published results from the same trial showing effects (or lack thereof) on growth, brain development, and blood health markers.
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Strand T, Chandyo R, McCann A, Ranjitkar S, Ulak M, Kvestad I, et al.. (2026). The Effect of Daily Vitamin B-12 Supplementation on the Incidence of Common Childhood Infections in Nepal: Secondary Outcomes from a Double-Blind Randomized Controlled Trial.. The Journal of nutrition. https://doi.org/10.1016/j.tjnut.2026.101534