Supplementing Iron and Development in Breastfed Infants (SIDBI Study)
Status:
Unknown status
Trial end date:
2019-06-01
Target enrollment:
Participant gender:
Summary
INTRODUCTION Exclusively breastfed infants are at risk of iron deficiency. American Academy
of Pediatrics (AAP) recommends iron supplementation in exclusively breastfed infants
beginning at 4 months of age. Uncertainty exists regarding the effects of iron
supplementation during infancy on neurodevelopmental outcomes in the absence of anemia.
AIM To establish whether psychomotor and mental development is influenced by early iron
supplementation in healthy, non-anemic, exclusively or predominantly breastfed infants.
METHODS Healthy term newborns will be recruited shortly after birth. If predominantly
breastfed (>50% daily feedings) and non-anemic at 4 months, they will be randomized to
receive either an iron supplement (approx.1mg/kg/day) or placebo until 9 months of age.
Participants will be assessed with use of Bayley Scales of Infant and Toddler Development
(Bayley III) at 12, 24 and 36 months of age.