Supplementing Iron and Development in Breastfed Infants (SIDBI Study)

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.

Timeline

Start

2015-09

Primary completion

2019-01

Completion

2019-06

Publications

• Svensson LK, Chmielewski G, Domellof M, Konarska Z, Piescik-Lech M, Spath C, Szajewska H, Chmielewska A. Iron in breastfed infants and behavior at 3 years: a randomized trial. Sci Rep. 2026 Jun 16;16(1):18664. doi: 10.1038/s41598-026-56401-z.
• Svensson L, Chmielewski G, Czyzewska E, Domellof M, Konarska Z, Piescik-Lech M, Spath C, Szajewska H, Chmielewska A. Effect of Low-Dose Iron Supplementation on Early Development in Breastfed Infants: A Randomized Clinical Trial. JAMA Pediatr. 2024 Jul 1;178(7):649-656. doi: 10.1001/jamapediatrics.2024.1095.
• Chmielewska A, Chmielewski G, Domellof M, Lewandowski Z, Szajewska H. Effect of iron supplementation on psychomotor development of non-anaemic, exclusively or predominantly breastfed infants: a randomised, controlled trial. BMJ Open. 2015 Nov 24;5(11):e009441. doi: 10.1136/bmjopen-2015-009441.

Drugs

Indications