title: Effect of iron supplementation on psychomotor development of non-anaemic, exclusively or predominantly breastfed infants: a randomised, controlled trial.
abstract: BACKGROUND
  Uncertainty exists regarding the effects of iron supplementation during infancy on neurodevelopmental outcomes in the absence of anaemia. The aim of the study is to establish whether psychomotor and mental development is influenced by early iron supplementation in healthy, non-anaemic, exclusively or predominantly breastfed infants.
  
  
  METHODS
  Healthy term infants will be recruited. If exclusively or predominantly breast fed (>50% of daily feedings) and not anaemic at 4 months, they will be randomised to receive either iron pyrophosphate (approximately 1 mg/kg) or placebo daily until 9 months of age. The primary outcome measure is neurodevelopment assessed with the Bayley Scales of Infant and Toddler Development (Bayley-III) at 12 months, and repeated at 24 and 36 months of age. Haematological parameters of iron metabolism also will be measured.
  
  
  BACKGROUND
  The Bioethics Committee of the Medical University of Warsaw approved the study protocol before recruitment started. Study results will be submitted to peer-reviewed journals in the fields of paediatrics and nutrition, and presented at relevant conferences.
  
  
  BACKGROUND
  NCT02242188.
authors.affiliation: Department of Paediatrics, Medical University of Warsaw, Warsaw, Poland.
authors.forename: Anna
authors.initials: A
authors.lastname: Chmielewska
authors.affiliation: Second Department of Obstetrics and Gynaecology, Medical University of Warsaw, Warsaw, Poland.
authors.forename: Grzegorz
authors.initials: G
authors.lastname: Chmielewski
authors.affiliation: Department of Clinical Sciences, Pediatrics, Umea University, Umea, Sweden.
authors.forename: Magnus
authors.initials: M
authors.lastname: Domellöf
authors.affiliation: Department of Epidemiology, Medical University of Warsaw, Warsaw, Poland.
authors.forename: Zbigniew
authors.initials: Z
authors.lastname: Lewandowski
authors.affiliation: Department of Paediatrics, Medical University of Warsaw, Warsaw, Poland.
authors.forename: Hania
authors.initials: H
authors.lastname: Szajewska
mesh_terms: D018798:Anemia, Iron-Deficiency / Q000517:prevention & control; D001942:Breast Feeding; D002657:Child Development / Q000187:drug effects*; D002985:Clinical Protocols; D019587:Dietary Supplements; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D007501:Iron / Q000494:pharmacology*; D019266:Iron, Dietary / Q000494:pharmacology*; D011597:Psychomotor Performance; D012016:Reference Values; D012107:Research Design
chemical_list: D019266:Iron, Dietary; D007501:Iron
keywords: RCT; children; iron