1. A 1-year Vitamin B12 supplementation program did not improve neurodevelopment, growth, and hemoglobin levels in stunted children, compared to a placebo.
Evidence Rating Level: 1 (Excellent)
Vitamin B12 is necessary in numerous metabolic processes in the body. Deficiency of this vitamin in children is associated with failure to thrive, stunted growth, poorer neurodevelopment, and macrocytic anemia. However, studies that have implemented B12 supplementation programs for children with B12 deficiency have yielded mixed results, with improved motor development observed in two facility-based RCTs, but no improvement found in a community-based RCT. The current study was a community-based, double-blind randomized controlled trial, with the aim of investigating the effectiveness of a 1-year B12 supplementation program. The study population consisted of 600 children (300 in each group), aged between 6 and 11 months old, with a length for age score below 1 standard deviation of the mean. The children were from Bhaktapur and surrounding areas of Kathmandu, in Nepal: These are low and middle-income communities know to have high rates of Vitamin B12 deficiency. For one year, children received 2 ug daily of a placebo or Vitamin B12 orally, with a reported 94% of doses being consumed. The primary outcomes were neurodevelopment (as measured by the Bayley-III scale), growth, and hemoglobin levels. The results did not find any significant differences in the primary outcomes between the placebo and Vitamin B12 groups. For instance, on the Bayley-III subscale, cognitive composite scores were 0.73 points higher in the placebo group than in the B12 group (95% CI -0.55 to 2.02, p = 0.261). Additionally, both groups had a mean growth of 12.5 cm (SD 1.8), with a mean difference of 0.20 cm (95% CI -0.23 to 0.63, p = 0.354). However, there was a difference in the secondary outcome: The metabolic profile in the B12 group showed improved B12 nutritional status, with lower levels of homocysteine and methylmalonic acid. For example, the placebo group had higher levels of methylmalonic acid by 60% (GMR 1.60, 95% CI 1.20-2.14, p < 0.001). Overall though, the study findings do not demonstrate that a 1-year Vitamin B12 supplementation program improves neurodevelopment, growth, and hemoglobin levels in the short-term.
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