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.

Infants of mothers receiving 250 µg daily vitamin B12 had significantly higher mental developmental quotients than infants of mothers receiving 50 µg.

• Mental developmental quotients (DQs) were higher in infants of group A (250 µg): 103.7 (SD 7.7) than group B (50 µg): 101.7 (SD 8.8); p=0.008
• This corresponds to a mean difference of 7.8 centiles (p=0.007)
• Neurodevelopment was assessed at 9-12 months using the Development Assessment Scale of Indian Infants
• 531 mothers completed the study (group A n=255; group B n=276)

Motor developmental quotients were not significantly different between the two supplementation groups.

• Mean motor DQs were not significantly different between groups A and B (p>0.05 implied by lack of reported significance)
• Both groups received daily oral methyl-cobalamin supplementation from first trimester through 6 months post partum
• The trial was conducted in two tertiary maternity care centres in India and Nepal

Maternal vitamin B12 levels increased from first to third trimester in both groups, with a significantly larger increase in the 250 µg group.

• Increase in group A (250 µg): 104.9 pg/mL (SD 159.1)
• Increase in group B (50 µg): 47.5 pg/mL (SD 118.0)
• Difference between groups was statistically significant: p<0.001
• Holotranscobalamin levels also improved significantly in both groups (p<0.001)

All infant vitamin B12 levels were within the normal range regardless of maternal supplementation dose.

• Both supplementation groups (250 µg and 50 µg) produced infants with normal vitamin B12 levels
• No significant differences in infant B12 levels between groups were reported as clinically abnormal
• Participants were predominantly vegetarian pregnant women enrolled in their first trimester

Newborn anthropometry, APGAR scores, morbidity profiles, and levels of serum ferritin, vitamin D, and folate were similar between the two supplementation groups.

• Newborn anthropometry, APGAR scores and morbidity profiles were similar in both groups (p>0.05)
• Serum ferritin, vitamin D and folate were similar between groups (p>0.05)
• No significant differences in baseline characteristics between mothers at both centres or in groups A and B were observed

The trial was a double-blind randomised controlled design conducted in two tertiary maternity care centres across India and Nepal, enrolling predominantly vegetarian pregnant women.

• Participants were pregnant women in their first trimester following a vegetarian diet
• Women were randomised to receive either 250 µg (group A) or 50 µg (group B) of methyl-cobalamin daily
• Supplementation ran from enrolment through 6 months post partum
• 531 mothers completed the study (group A n=255; group B n=276)
• Primary outcomes were infant neurodevelopment at 9-12 months and biochemical B12 status in mothers and infants