Effect of Vitamin B12 Supplementation on Neurodevelopment and Growth in Breastfed Infants Aged 1 to 2 Months

What this Trial Is About

Vitamin B12 deficiency is a common micronutrient shortage worldwide, including in places like Norway. Vitamin B12 is essential for healthy cell growth and brain development, especially in infants. This research investigates the effects of daily oral vitamin B12 supplements on infants brain development and growth. The study is a randomized, controlled trial enrolling breastfed infants to assess neurodevelopment, growth, and other health outcomes related to vitamin B12 status. Infants aged between 1 and 2 months will be screened for high plasma total homocysteine levels. Those with elevated levels will receive a 400 microgram dose of vitamin B12 cyanocobalamin via intramuscular injection. Infants without elevated levels will have their blood samples stored and analyzed after one year without receiving the supplement. Pregnant women are informed about the study early, and infants with confirmed deficiency receive treatment outside the randomized trial. Participants will be monitored with various assessments including neurodevelopmental evaluations at 12 months and later in childhood, growth measurements, and measures of nervous system function. Blood samples will be collected at 1 to 3 months and 12 months to check vitamin levels. Safety is tracked with reports of any adverse events three months after treatment. The study will last at least 12 months with ongoing follow-up to understand the impact of vitamin B12 supplementation on infant health.

Early Infant Micronutrition and Development