In a recent study published in scalpelResearchers evaluated the effects of maternal vitamin b12 (cyanocobalamin) supplementation on the neurodevelopment and development of children born in nepal.
Stady: Effect of vitamin B12 supplementation during pregnancy on infant growth and development in Nepal: a community-based, double-blind, randomized, placebo-controlled trial. Image credit: NatchaS/Shutterstock.com
Children born in low- and middle-income countries may not achieve full growth and neurodevelopment due to the prevalence of low or marginal levels of cyanocobalamin in the blood.
Cyanocobalamin is critical in various physiological processes in the human body, especially neurological functions.
Cyanocobalamin is especially essential during pregnancy and early lactation to improve pregnancy outcomes and promote the growth and neurological development of infants.
Assessment of neurological outcomes among infants after administration of cyanocobalamin to mothers during pregnancy can inform decision-making and policy regarding antenatal care.
In this study, researchers investigated whether giving vitamin b12 supplements to mothers from the initial gestation period until six months postpartum could improve neurodevelopmental outcomes in neonates born in nepal.
This double-blind, community-based, placebo-controlled clinical trial included 800 expecting women, ages 20.0 to 40.0 years, who had completed a maximum of 15.0 weeks’ gestation.
Participants were randomly assigned in a 1:1 ratio (1:1) to receive 50.0 μg of oral cyanocobalamin daily (intervention group, n = 400) or placebo (placebo group, n = 400) until six months after birth.
Participants were recruited from home visits and ambulatory health departments of three Nepalese hospitals between 28 March 2017 and 15 October 2020. The scientists generated the allocation list independently, and associated PINs of the participants.
Participants and investigators were blinded to the intervention, and the participants were followed until May 18, 2022. Serum samples were obtained from the participants to measure vitamin B12 levels, expressed in mol/L.
The primary study outcomes were linear growth, assessed using height-for-age (LAZ) scores at 1 year from age 12, and neurological development, assessed using the Bayley Scales of Infant and Toddler Development, Third Edition (Bayley-III). Composite cognitive scores of six months and one year of age.
Secondary outcomes included stillbirths, infant deaths, and adverse events (AEs). The team evaluated the results of the study among the intent-to-treat (ITT) sample population.
Stillbirths, miscarriages, births lost to follow-up and those born to mothers who chose to discontinue the study were excluded. In addition, individuals were excluded from the analysis of outcomes at six months of age because the infant was born outside the window period or if their mothers were unwilling to travel due to the COVID-19 pandemic.
At study entry, 569 women (71.0%) had serum vitamin B12 levels less than 221.0 pmol/L, indicative of marginal or low vitamin B12 status.
In the intervention group, of the 400 women, 23 were lost to follow-up, three women refused to continue, 19 women experienced miscarriage or medical termination of pregnancy, and 377 live births were reported.
In the placebo group of 400 women, 17 women were lost to follow-up, one woman refused to continue, eight women had miscarriages or had their pregnancies medically terminated, and 383 live births were reported.
In both groups, 47 participants (6.0%) were lost to follow-up, largely due to spontaneous abortion or medical termination of pregnancy. Infant deaths or stillbirths were noted for three (1.0%) and nine (2.0%) women in the intervention and placebo groups, respectively.
Vitamin b12 supplementation did not significantly affect the results of the primary study, despite significant improvements in serum vitamin b12 levels among the mothers.
The mean height-versus-age Z-scores obtained at 1 year of age were -0.570 and -0.550 for the intervention (366 neonates) and placebo (363 neonates) groups, respectively, with a difference of 0.020 in mean.
Mean Bayley-III scores were slightly greater among participants treated with vitamin B12 (97.70, 364 infants) than among participants treated with placebo (97.10, 361 infants), with a difference of 0.50 in mean.
Overall, the results of the study showed that despite vitamin B12 deficiency among Nepalese pregnant women and significant improvement in serum vitamin B12 levels after administration of vitamin B12 to mothers between early pregnancy and six months postpartum, vitamin B12 supplementation (50.0 mcg of vitamin (B12 daily) did not significantly improve newborn growth and development.
The study findings support current prenatal guidelines published by the World Health Organization (WHO) against regular vitamin B12 supplementation for mothers during pregnancy.