title: The Infant Fish Oil Supplementation Study (IFOS): design and research protocol of a double-blind, randomised controlled n--3 LCPUFA intervention trial in term infants.
abstract: METHODS
  The Infant Fish Oil Supplementation Study is a double-blind randomised controlled trial investigating whether the incidence of allergic disease can be reduced and developmental outcomes enhanced through supplementation with omega-3 fatty acids. Infants at high risk of developing allergic disease will be randomised to receive either fish oil or olive oil supplements until 6 months of age and followed up at six postnatal clinic visits to assess allergy outcomes and infant neurodevelopment.
  
  
  METHODS
  Study groups to consist of a treatment group allocated to receive 650 mg of fish oil daily (250-280 mg docosahexaenoic acid and at least 60 mg eicosapentaenoic acid and a placebo group (olive oil) from birth to 6 months of age.
  
  
  RESULTS
  Allergy outcomes will be assessed by clinical history, clinical assessments and allergen skin prick tests at the 12, 30 and 60 month visits. Neurodevelopmental assessments to be conducted at 18 months, and language questionnaires at 12, 18 and 30 months. Samples will be collected from mothers antenatally, from infants at birth, and at clinic visits from 6 months onwards for immunological assessments. Fatty acid composition to be measured in erythrocytes and plasma (at birth and after the supplementation period) to assess the effect of the intervention on fatty acid status. Information on medical history, diet and other lifestyle factors at an antenatal clinic visit and postnatal clinic visits will also be collected.
  
  
  CONCLUSIONS
  This study is designed to examine clinically relevant effects of a novel, non-invasive and potentially low cost approach to reduce the incidence of allergic disease and facilitate neurodevelopment during early childhood.
authors: School of Paediatrics and Child Health, University of Western Australia, Perth, WA, Australia. smeldrum@meddent.uwa.edu.au
authors: S J
authors: SJ
authors: Meldrum
authors: N
authors: N
authors: D'Vaz
authors: J
authors: J
authors: Dunstan
authors: T A
authors: TA
authors: Mori
authors: S L
authors: SL
authors: Prescott
mesh_terms: D002985:Clinical Protocols; D019587:Dietary Supplements; D004281:Docosahexaenoic Acids / Q000627:therapeutic use; D004311:Double-Blind Method; D015118:Eicosapentaenoic Acid / Q000627:therapeutic use; D015525:Fatty Acids, Omega-3 / Q000627:therapeutic use*; D005231:Fatty Acids, Unsaturated / Q000627:therapeutic use; D005260:Female; D005395:Fish Oils / Q000627:therapeutic use*; D006801:Humans; D006967:Hypersensitivity / Q000517:prevention & control*; D007223:Infant; D007229:Infant Welfare; D007231:Infant, Newborn; D008297:Male; D012107:Research Design
chemical_list: D015525:Fatty Acids, Omega-3; D005231:Fatty Acids, Unsaturated; D005395:Fish Oils; D004281:Docosahexaenoic Acids; D015118:Eicosapentaenoic Acid