title: Docosahexaenoic acid supplementation and time at achievement of gross motor milestones in healthy infants: a randomized, prospective, double-blind, placebo-controlled trial.
abstract: BACKGROUND
  Docosahexaenoic acid (DHA) intake throughout the first year of life is associated with neurodevelopmental and neuropsychological benefits. Few studies have evaluated the role of DHA intakes on age at achievement of gross motor milestones.
  
  
  OBJECTIVE
  The objective was to assess the effects of DHA supplementation throughout the first year of life on the achievement of four gross motor milestones in healthy infants.
  
  
  METHODS
  In this multicenter prospective, randomized, double-blind, placebo-controlled trial, 1160 healthy neonates were assigned to receive supplementation with either 20 mg liquid DHA (n = 580) or placebo (n = 580) orally once daily throughout the first year of life. The primary endpoint was the time at achievement of 4 gross motor milestones (sitting without support, hands-and-knees crawling, standing alone, and walking alone). All analyses were performed on an intention-to-treat basis.
  
  
  RESULTS
  The time to achievement of sitting without support was shorter (P < 0.001) in infants who received DHA [median: 26 wk; interquartile range (IQR): 24-29 wk] than in those who received placebo (27 wk; 26-31 wk). No significant difference between infants who received DHA or placebo was found for hands-and-knees crawling [39 wk (34-44 wk) compared with 40 wk (35-44 wk), respectively], standing alone [49 wk (43-55 wk) compared with 49 wk (44-57 wk), respectively], and walking alone [55 wk (50-60 wk) compared with 56 wk (52-61 wk), respectively].
  
  
  CONCLUSIONS
  Despite the 1-wk advance in sitting without support associated with DHA supplementation, no demonstrable persistent effects of DHA supplementation on later motor development milestones were found. Thus, the long-term clinical significance of the 1-wk change in sitting without support, if any, remains unknown. This trial is registered at (clinicaltrials.gov) as NCT00610922.
authors.affiliation: Department of Pediatrics, San Paolo Hospital, University of Milan, Milan, Italy. carlo.agostoni@unimi.it
authors.forename: Carlo
authors.initials: C
authors.lastname: Agostoni
authors.forename: Gian Vincenzo
authors.initials: GV
authors.lastname: Zuccotti
authors.forename: Giovanni
authors.initials: G
authors.lastname: Radaelli
authors.forename: Roberto
authors.initials: R
authors.lastname: Besana
authors.forename: Alberto
authors.initials: A
authors.lastname: Podestà
authors.forename: Andrea
authors.initials: A
authors.lastname: Sterpa
authors.forename: Amilcare
authors.initials: A
authors.lastname: Rottoli
authors.forename: Enrica
authors.initials: E
authors.lastname: Riva
authors.forename: Marcello
authors.initials: M
authors.lastname: Giovannini
mesh_terms: D002657:Child Development / Q000187:drug effects; D019587:Dietary Supplements; D004281:Docosahexaenoic Acids / Q000494:pharmacology*; D004311:Double-Blind Method; D015525:Fatty Acids, Omega-3 / Q000494:pharmacology*; D005260:Female; D006801:Humans; D007223:Infant; D007227:Infant Nutritional Physiological Phenomena / Q000502:physiology*; D007231:Infant, Newborn; D008297:Male; D009048:Motor Skills / Q000187:drug effects* / Q000502:physiology*; D011446:Prospective Studies; D016896:Treatment Outcome
chemical_list: D015525:Fatty Acids, Omega-3; D004281:Docosahexaenoic Acids