Supplementing Iron and Development in Breastfed Infants (SIDBI Study)

• Status: Unknown status
• Trial end date: 2019-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Medical University of Warsaw
• Treatments: Iron

Criteria

Inclusion Criteria:

• Term singleton infants (>37 weeks gestational age)

• Birth weight > 2500g

• Healthy at inclusion

• Breastfed exclusively or predominantly (>50% meals) at inclusion

• No previous iron supplementation

• No previous blood transfusion

• Informed consent given

Exclusion Criteria:

• preterm delivery (<37 weeks of gestation)

• birth weight < 2500 g

• multiple pregnancy

• major illness or congenital anomaly

• being <50% breastfed at the time of inclusion

• food allergy

• anaemia (Hb <105 g/L [10.5 g/dL]) at inclusion, lack of informed consent