title: Does n-3 LCPUFA supplementation during pregnancy increase the IQ of children at school age? Follow-up of a randomised controlled trial.
abstract: Despite recommendations that pregnant women increase their docosahexaenoic acid (DHA) intake to support fetal brain development, a recent systematic review found a lack of high-quality data to support the long-term effects of DHA supplementation on children's neurodevelopment.
  
  
  
  We will assess child neurodevelopment at 7 years of age in follow-up of a multicentre double-blind randomised controlled trial of DHA supplementation in pregnancy. In 2010-2012, n=2399 Australian women with a singleton pregnancy <21 weeks' gestation were randomised to receive 3 capsules daily containing a total dose of 800 mg DHA/day or a vegetable oil placebo until birth. N=726 children from Adelaide (all n=97 born preterm, random sample of n=630 born at term) were selected for neurodevelopmental follow-up and n=638 (preterm n=85) are still enrolled at 7 years of age. At the 7-year follow-up, a psychologist will assess the primary outcome, IQ, with the Wechsler Abbreviated Scale of Intelligence, Second Edition. Specific measures of executive functioning (Fruit Stroop and the Rey Complex Figure), attention (Test of Everyday Attention for Children), memory and learning (Rey Auditory Verbal Learning Test), language (Clinical Evaluation of Language Fundamentals, Fourth Edition) and basic educational skills (Wide Range Achievement Test, Fourth Edition) will also be administered. Caregivers will be asked to complete questionnaires measuring behaviour and executive functioning. Families, clinicians and research personnel are blinded to group assignment with the exception of families who requested unblinding prior to the follow-up. All analyses will be conducted according to the intention-to-treat principal.
  
  
  
  All procedures will be approved by the relevant institutional ethics committees prior to start of the study. The results of this study will be disseminated in peer-reviewed journal publications and academic presentations.
  
  
  
  ACTRN12605000569606 and ACTRN12614000770662.
authors.affiliation: Women's & Children's Health Research Institute, North Adelaide, South Australia, Australia South Australian Health and Medical Research Institute, Adelaide, Australia.
authors.forename: Jacqueline F
authors.initials: JF
authors.lastname: Gould
authors.affiliation: Victorian Infant Brain Studies (VIBeS), Murdoch Children's Research Institute, Royal Children's Hospital, Parkville, Victoria, Australia.
authors.forename: Karli
authors.initials: K
authors.lastname: Treyvaud
authors.affiliation: Women's & Children's Health Research Institute, North Adelaide, South Australia, Australia School of Public Health, The University of Adelaide, South Australian Health and Medical Research Institute, Adelaide, Australia.
authors.forename: Lisa N
authors.initials: LN
authors.lastname: Yelland
authors.affiliation: Victorian Infant Brain Studies (VIBeS), Murdoch Children's Research Institute, Royal Children's Hospital, Parkville, Victoria, Australia.
authors.forename: Peter J
authors.initials: PJ
authors.lastname: Anderson
authors.affiliation: School of Public Health, The University of Adelaide, South Australian Health and Medical Research Institute, Adelaide, Australia.
authors.forename: Lisa G
authors.initials: LG
authors.lastname: Smithers
authors.affiliation: FOODplus Research Centre, School of Agriculture, Food and Wine, Discipline of Paediatrics, The University of Adelaide, Glen Osmond, South Australia, Australia.
authors.forename: Robert A
authors.initials: RA
authors.lastname: Gibson
authors.affiliation: Neonatal Services, Women's and Children's Hospital, North Adelaide, South Australia, Australia.
authors.forename: Andrew J
authors.initials: AJ
authors.lastname: McPhee
authors.affiliation: Women's & Children's Health Research Institute, North Adelaide, South Australia, Australia South Australian Health and Medical Research Institute, Adelaide, Australia.
authors.forename: Maria
authors.initials: M
authors.lastname: Makrides
mesh_terms: D000284:Administration, Oral; D000328:Adult; D001315:Australia / Q000453:epidemiology; D002648:Child; D002657:Child Development / Q000187:drug effects* / Q000502:physiology; D019587:Dietary Supplements; D004281:Docosahexaenoic Acids / Q000008:administration & dosage; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007231:Infant, Newborn; D007360:Intelligence / Q000187:drug effects* / Q000502:physiology; D007858:Learning; D011247:Pregnancy; D037841:Pregnant People; D011295:Prenatal Care; D011297:Prenatal Exposure Delayed Effects
chemical_list: D004281:Docosahexaenoic Acids
keywords: Docosahexaenoic acid; LCPUFA; cognition; neurodevelopment; omega-3 fatty acids; prenatal