Effects of Prenatal DHA Supplements on Infant Development
Condition: Pregnancy
Study type: Interventional

Summary: 
      This research study research is about the significance of polyunsaturated fatty acids (PUFAs)
      for human development. Specifically, the study team will assess the effect of docosahexanoic
      acid (DHA) supplementation during pregnancy on infant growth and development through a
      randomized controlled intervention trial in Cuernavaca, Mexico. This is a collaborative
      effort between the Rollins School of Public Health, Emory University, the Instituto Nacional
      de Salud Publica (INSP) and the Instituto Mexicano del Seguro Social (IMSS), Cuernavaca,
      Mexico. Pregnant women attending the IMSS General Hospital I are recruited between 18-22
      weeks gestation and assigned randomly to receive either DHA (400 mg) or a placebo daily until
      delivery. The main study outcomes include a) birth outcomes: birth size, gestational age,
      cord blood levels of DHA and neurodevelopment b) maternal blood and breast milk DHA levels at
      1 and 3 months post-partum, c) postnatal growth and development during the first 5 years of
      age and d) infant DHA status at 3, 12 and 18 months.
    

Detailed description: 
      This research study is about the significance of polyunsaturated fatty acids (PUFAs) for
      human development. Specifically, the study team will assess the effect of docosahexanoic acid
      (DHA) supplementation during pregnancy on infant growth and development through a randomized
      controlled intervention trial in Cuernavaca, Mexico. This is a collaborative effort between
      the Rollins School of Public Health, Emory University, the Instituto Nacional de Salud
      Publica (INSP) and the Instituto Mexicano del Seguro Social (IMSS), Cuernavaca, Mexico.
      Pregnant women attending the IMSS General Hospital I are recruited between 18-22 wks
      gestation and assigned randomly to receive either DHA (400 mg) or a placebo daily until
      delivery. The main study outcomes include a) birth outcomes: birth size, gestational age,
      cord blood levels of DHA and neurodevelopment b) maternal blood and breast milk DHA levels at
      1 and 3 mo post-partum c) postnatal growth and development during the first 5 years of age
      and d) infant DHA status at 3, 12 and 18 mo. All data collection is carried out at the study
      headquarters (IMSS) except for home environment that is assessed during home visits. Physical
      growth (length, weight, and head circumference) and infant and child development (visual and
      auditory evoked potentials, visual attention, Bayley scales of infant development, McCarthy
      child development score, Hearts and Flowers stroop test, and other computerized child
      development tests) are measured at birth, 1, 3, 6, 9, 12, 18, 24, 36 months and at 4 and 5
      years of age by trained workers. Data are also obtained on socioeconomic status, obstetric
      history, maternal diet, anthropometry and intelligence, quality of home environment and
      infant feeding practices. Data analysis will include group comparisons (intent-to-treat)
      after ensuring effectiveness of randomization, and structural equation modeling to examine
      the various pathways by which DHA supplementation during pregnancy affects child growth and
      development. The findings of this project will contribute significantly to our understanding
      of the functional consequences of DHA supplementation during pregnancy.
    

Intervention name(s): DHA; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 400 mg/d of docosahexanoic acid (DHA) during pregnancy; 2 tablets daily during pregnancy
Other intervention name(s): Martek Algal DHA; Specially formulated by Martek Biosciences
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: birth size, gestational age, development, child growth,; prenatal nutrition, DHA