Effect of Long-Chain Polyunsaturated Fatty Acid Supplementation on Toddler Cognition
Condition: Infant Development
Study type: Interventional

Summary: 
      The hypothesis to be examined is that dietary LCP-supplementation in the second and third
      years of life will improve cognitive and visual maturation in early childhood.
    

Detailed description: 
      A total number of 114 toddlers at 12 months ± 2 weeks of age will be recruited and randomized
      to two groups (placebo or LCP-supplemented). Cognition, visual function, anthropometric,
      immunologic and biochemical status, and health will be assessed upon entry to evaluate
      equality between study groups.

      The primary outcome measure for Part A will be maturation of cognition at 24 months ± 2 weeks
      of age (after 12 months of LCP dietary intervention) as assessed by the Bayley Scales of
      Infant Development (BSID)-version III. In Part B, maturation of cognition at 36 months of age
      (after 24 months of LCP dietary intervention) will be assessed using the Wechsler Preschool
      and Primary Scale of Intelligence (WPPSI-III).

      The study supplements are (1) a micro-encapsulated powder containing a 1:1 ratio of the
      omega-3 fatty acid, docosahexaenoic acid (DHA) and the omega-6 fatty acid, arachidonic acid
      (ARA) from algal and fungal sources, respectively; and (2) a micro-encapsulated powder
      containing corn oil placebo. Two foil-packets containing either active intervention or
      placebo will provide 200mg DHA and 200mg ARA or 400 mg placebo oil per day to the toddler.
      Two packets of the powders will be added each day to a selection of recommended foods (e.g.,
      yogurt). The duration of treatment will be from 12 to 24 months of age in Part A and in Part
      B will be from 24 to 36 months and followed to 42 months of age.

      Secondary outcome measures are:

        -  COGNITION: Peabody Picture Vocabulary Test (PPVT-II; 42 mo) and the Bracken Basic
           Concept Scale (42 mo).

        -  VISION: Grating & stereoacuity (12, 24 & 36 mo); letter acuity at 36 mo.

        -  ANTHROPOMETRICS, HEALTH INDICES & DIETARY STATUS: Weight, height, head circumference,
           waist & hip measures, body mass index (BMI), skin fold fat deposition, heart rate (HR),
           blood pressure (BP), omega-3-targeted food questionnaire (at 12,18, 24, 30, 36, & 42
           mo), childhood illnesses from birth to 36 months with emphasis on allergy and asthma
           chart review and a questionnaire to determine family history of asthma and allergy as
           well as the child's exposure to smoking (12, 24 & 36 mo).

        -  EXECUTIVE FUNCTION: Behavior Rating Inventory of Executive Function - Preschool Version
           (BRIEF-P questionnaire; 24 & 36 mo), Kansas Reflection-Impulsivity Scale for
           Preschoolers (KRISP; 42 mo), Dimensional Change Card Sort (DCCS; 42 mo), three Stroop
           Tasks (42 mo), the Grass/Snow task (42 months), and the Day/Night Task (42 months).

        -  SLEEP: Brief Infant Sleep Questionnaire (BSIQ;12 & 24 mo), Children's Sleep Habits
           Questionnaire (CSHQ; 36 & 42 mo).

        -  IMMUNE FUNCTION: plasma cytokine levels (12 & 24 mo), skin prick tests for specific IgEs
           (12 & 24 mo), plasma total IgE, salivary (secretory) IgA (12 & 24 mo), plasma C-reactive
           protein (CRP;12 & 24 mo).

        -  INDICES OF NEURAL TISSUE COMPOSITION AND COMPLIANCE: Total RBC fatty acid analysis (12 &
           24 mo), buccal cheek cell phospholipids fatty acid analysis (12, 24, & 36 mo).
    

Intervention name(s): Docosahexaenoic acid (DHA) and arachidonic acid (ARA); Corn oil placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Micro-encapsulated powder containing the long-chain polyunsaturated fatty acids, DHA to ARA in a 1:1 ratio. Two foil-packets containing active intervention (200mg DHA+200mg ARA) or placebo (400 mg corn oil) per day added to a selection of recommended foods.; Micro-encapsulated powder containing corn oil as the placebo.
Other intervention name(s): Long-chain polyunsaturated fatty acids; omega-3 fatty acids; omega-6 fatty acids; Long-chain polyunsaturated fatty acids; Omega-6 fatty acids
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: cognition; vision; immunology; DHA; ARA; infant; nutrition