Essential Fatty Acid Nutrition For 1-2 Yr-Olds
Condition: Infant Nutrition
Study type: Interventional

Summary: 
      This is a prospective longitudinal study that will involve 200 infants enrolled at 12-13
      months of age. The study will use a classic nutrition design to assess if infants' feeding
      practices in Canada place infants 1-2 years of age at risk for low long chain polyunsaturated
      fatty acid (LCPUFA), nutrients known to influence growth, and brain and immune system
      development. On enrollment, infants will be assigned at random to a nutrition supplement
      providing omega 6 and omega 3 LCPUFA or a PUFA placebo.
    

Detailed description: 
      The objectives are to1. determine the change in dietary fat and PUFA intakes, change in
      biochemical measures of fatty acid status prospectively from enrollment to 24 months-of-age
      and 2. to use a nutritional intervention with LCPUFA to address if limiting status of these
      nutrients impacts growth and development to 24 months-of-age. Primary Endpoints are
      distributions of developmental tests scores, growth quality and parental reports of child
      illness. The Bayley Mental and Motor Scales (BSID-III), Peabody Picture Test, Beery Buktenica
      Developmental Test, Auditory Continuous Performance Test and Test of Attention and
      Distractibility are used. Growth is assessed as height, weight, and adipose tissue mass and
      distribution. Child illness is reported by the parent. Secondary endpoints are physiologic
      measures of blood pressure, heart rate and heart rate variability, and the genetic variables
      in fatty acid metabolism on fatty acid status and outcome. Blood is collected at enrolment
      and at 24 months-of-age. Lipids and fatty acids are assessed on plasma and blood cells.
      Routine, potentially confounding nutrients including iron, vitamin D, choline, folate and B12
      are assessed. DNA is extracted from blood cells for genotyping. Dietary intake is assessed
      using a food frequency questionnaire (FFQ), 3 day food diaries and 24 hour recalls. A parent
      report illness dairy and questionnaire modified from the International Study of Asthma and
      Allergies in Childhood is used to assess illness incidence and duration. Descriptive
      statistics will be used to present subject characteristics, dietary intakes, growth and
      physiological measures and test results of total fat. Logistic regression, with
      multivariable-adjusted odds ratios (ORs) of a negative outcome and corresponding 95% CI will
      be sued to assess the effect of LCPUFA status on development, growth and health outcomes. For
      all multivariate models, potential confounders will be screened in stepwise fashion, and any
      covariate with a regression coefficient P-value < 0.05 (two-sided) will be retained.
      Performance on tests will be compared as LCPUFA status in the lowest quintile compared to
      highest quintile of outcome (i.e. the two ends of the distribution differ in LCPUFA status).
    

Intervention name(s): LCPUFA Supplement; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Children 12-13 months old will be assigned at random to receive either a nutrition supplement containing LCPUFA or a placebo until 24 months-of-age; Children 12-13 months old will be assigned at random to receive either a nutrition supplement containing LCPUFA or a placebo until 24 months-of-age
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: Polyunsaturated fatty acids; Cognitive development; Growth; Infection