Docosahexaenoic acid supplementation and time at achievement of gross motor milestones in healthy infants: a randomized, prospective, double-blind, placebo-controlled trial.
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.
Agostoni
Carlo
C
Department of Pediatrics, San Paolo Hospital, University of Milan, Milan, Italy. carlo.agostoni@unimi.it
Zuccotti
Gian Vincenzo
GV
Radaelli
Giovanni
G
Besana
Roberto
R
Podestà
Alberto
A
Sterpa
Andrea
A
Rottoli
Amilcare
A
Riva
Enrica
E
Giovannini
Marcello
M
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
D015525:Fatty Acids, Omega-3; D004281:Docosahexaenoic Acids