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Maternal supplementation of vitamin B12 in predominantly vegetarian pregnant women improves their vitamin B12 status and the neurodevelopment of their infants: the MATCOBIND multicentric double-blind randomised control trial.

  • 2026-03
  • BMJ paediatrics open 10(1)
    • Jitender Nagpal
    • Manu Mathur
    • Swapnil Rawat
    • Atul Singhal
    • Rajendra Pant
    • Anita Shah
    • Laura Nixon
    • Vijay Kumar Mishra
    • Deepti Nagrath
    • Michelle Heys
    • Mario Cortina-Borja
    • Colin Michie
    • Jageshwor Gautam
    • Shailendra Bir Karmacharya
    • Snighda Rai
    • Monica Lakhanpaul

Study Design

Type
Randomized Controlled Trial (RCT)
Sample size
n = 276
Population
531 pregnant women in their first trimester, following a vegetarian diet, in India and Nepal
Methods
Double-blind, randomised controlled trial; daily oral supplement of 250 µg or 50 µg of methyl-cobalamin from enrolment to 6 months post partum
Blinding
Double-blind
Duration
from first trimester to 6 months post partum
Funding
Unclear
  • Large Human Trial

Background

Vitamin B12 deficiency is common in populations with limited animal-source foods and has been linked to delayed infant neurodevelopment and adverse pregnancy outcomes. Evidence on the benefits of maternal B12 supplementation for improving infant neurodevelopment remains mixed, particularly in low-income and middle-income countries where deficiency is prevalent.

Methods

This double-blind, randomised controlled trial was conducted in two tertiary maternity care centres in India and Nepal. Pregnant women in their first trimester, following a vegetarian diet, were enrolled and randomised to receive either a daily oral supplement of 250 µg (group A) or 50 µg (group B) of methyl-cobalamin from enrolment to 6 months post partum. The primary outcomes were infant neurodevelopment assessed at 9-12 months using the Development Assessment Scale of Indian Infants and biochemical B12 status in mothers and infants measured through blood tests.

Results

531 mothers completed the study (group A n=255; group B n=276). There were no significant differences in baseline characteristics between mothers at both centres or in groups A and B. Mental developmental quotients (DQs) were higher in the infants of group A: 103.7 (7.7) than group B: 101.7 (8.8); p=0.008). This corresponds to a mean difference of 7.8 centiles (p=0.007). Mean motor DQs were not significantly different between the groups. Maternal vitamin B12 levels rose from the first to third trimester in both groups, with a larger increase in group A (104.9 pg/mL (SD 159.1)) than group B (47.5 pg/mL (SD 118.0)), p<0.001. Holotranscobalamin levels improved similarly (p<0.001). All infant levels of vitamin B12 were within the normal range. Newborn anthropometry, APGAR scores and morbidity profiles were similar in both groups (p>0.05). Serum ferritin, vitamin D and folate were similar (p>0.05).

Conclusions

Daily supplementation with 250 µg of vitamin B12 during pregnancy in vegetarian mothers significantly improved infant mental DQ and maternal B12 status compared with a 50 µg dose.

Research Insights

  • Vitamin B12→Improved Mental Developmental Quotient

    Mental developmental quotients (DQs) were higher in the infants of group A: 103.7 (7.7) than group B: 101.7 (8.8); p=0.008). This corresponds to a mean difference of 7.8 centiles (p=0.007).

    Effect
    Beneficial
    Effect size
    Moderate
    Dose
    250 µg/day
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