N-3 Fatty Acid Requirements for Human Development
Condition: Pregnancy
Study type: Interventional
Phase: Phase 1

Summary: 
      Polyunsaturated fatty acids known as n-3 fatty acids are essential dietary nutrients for
      humans, and are known to be important to reducing the risk of certain diseases, particularly
      those related to neural system, cardiovascular system and immune system. Among the different
      n-3 fatty acids, docosahexaenoic acid (DHA) is present in particularly high amounts in the
      brain and retina, and is accumulated in large amounts in these organs during the last
      trimester of fetal development and first few months after birth. The n-3 fatty acids are
      present in the diet as linolenic acid which is found in vegetable and seed oils, and as DHA
      which is only found in animal tissue fats, with fatty fish being the richest dietary source.
      Humans are able to convert linolenic acid to DHA, but the conversion is believed to be slow
      in human and possibly inadequate to support the needs for DHA for the developing brain.
      Information from our work and those of others has suggested that DHA is important during
      pregnancy, however specific evidence is lacking to show that the DHA status of pregnant women
      in low, or that improvement in the DHA status of Canadian women during pregnancy will have
      benefit to early infant an child development. There is no evidence that infants of vegans and
      vegetarians, or women who do not eat DHA are at risk for developmental delays. The purpose of
      this study is to investigate whether a dietary supplement of DHA during pregnancy has any
      effect on infant birth weight, or indices of infant growth, visual, mental and motor skill
      development.
    

Detailed description: 
      This is a randomized, blinded prospective study with 2 groups: placebo and group supplemented
      with DHA. Women are randomized at 16 weeks gestation without knowledge of their dietary fatty
      acid intake. Only healthy women expecting to deliver a single infant with no known or
      anticipated maternal or fetal complications are enrolled. Maternal venous blood is collected
      at 16 and 36 weeks of gestation and used to assess the maternal DHA status and effect of DHA
      supplementation. Dietary information is collected at 16 and 36 weeks of gestation to
      determine usual fatty acid intakes. Following delivery, fetal cord blood is collected to
      assess transfer of DHA from mother to fetus. Breast milk samples are collected from all
      breast feeding mothers at 1 and 2 months postpartum. The mother -infant pairs are followed
      for 18 months. Measures include visual acuity, language, motor and mental development, and
      growth and dietary intakes.
    

Intervention name(s): omega 3 fatty acids; vegetable oil
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): The supplements are taken orally with a meal, each day. The amount of the omega 3 fatty acid docosahexaenoic acid is 400 mg/day; taken in two 500 mg capsules each providing 200 mg docosahexaenoic acid. The placebo is two 500 mg capsules soybean/canola oil. Both the supplement and placebo are a total of 1 gm/day (2x500 mg) and about 10 calories per day.; The supplement is a dietary supplement of vegetable oil as a placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Prevention
Keywords: n-3 supplementation during pregnancy; DHA and pregnancy, infant development; n-3 status and gestation; DHA and visual acuity and cognition during infancy