Milk-cereal mix supplementation during infancy and impact on neurodevelopmental outcomes at 12 and 24 months of age: a randomized controlled trial in India.

Inadequate protein intake and lack of micronutrients may affect neurodevelopment in infants. This randomized controlled trial was conducted to measure the effect of two milk-cereal mixes with modest and high amounts of protein and enriched with multiple micronutrients (MMN), given between 6-12 months, on cognitive, language, motor and behavioural scores at 12 and 24 months of age, compared to no-supplementation. The two supplements were also compared with each other. The study was conducted in urban Delhi, India and the infants were randomized in a 1:1:1 ratio to the three study groups. At 12 and 24 months of age, 1134 and 1214 children were available, respectively. At 12 months of age, compared to no supplement group, an increase in the motor scores (mean difference, MD 1.52, 95% CI: 0.28, 2.75) and a decrease in the infant temperament scores (mean difference, MD -2.76, 95% CI: -4.23, -1.29) in the modest protein group was observed. Those in the high protein group had lower socio-emotional scores (MD -1.40, 95% CI: -2.43, -0.37) and higher scores on infant temperament scale (MD 2.05, 95% CI: 0.62, 3.48) when compared to modest protein group. At 24 months, no significant differences in any of the neurodevelopment scores between the three study groups was found. In conclusion, supplementation with modest amount of protein and MMN may lead to short term small improvements in motor function and infant temperament. There appears no advantage of supplementing with high protein, rather negative effects on infant behaviour were observed.