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Docosahexaenoic acid supplementation and time at achievement of gross motor milestones in healthy infants: a randomized, prospective, double-blind, placebo-controlled trial^1,2,3

¹ From the Department of Pediatrics, San Paolo Hospital, University of Milan, Milan, Italy (CA, ER, and MG); the Department of Pediatrics, Luigi Sacco Hospital, University of Milan, Milan, Italy (GVZ); the Unit of Medical Statistics, San Paolo Hospital, University of Milan, Milan, Italy (GR); the Unit of Pediatrics and Neonatology, Presidio Ospedaliero di Desio, Desio, Italy (RB); the Department of Pediatrics and Neonatology, San Carlo Borromeo Hospital, Milan, Italy (AP); the Unit of Pediatrics and Neonatology, Presidio Ospedaliero di Carate Brianza, Carate Brianza, Italy (AS); and the Unit of Pediatrics and Neonatology, Presidio Ospedaliere di Cernusco sul Naviglio and Presidio Ospedaliero di Melzo, Cernusco sul Naviglio and Melzo, Italy (AR).

² Humana Italia SpA kindly supplied the intervention and control products free of charge.

³ Address reprint requests and correspondence to C Agostoni, Department of Pediatrics, San Paolo Hospital, University of Milan, Via A Di Rudinì 8, I-20142 Milan, Italy. E-mail: carlo.agostoni{at}unimi.it.

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.

Design: 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.