Skip to main content
OpenTrials
Completed

NCT Number: NCT00646360

Effects of Prenatal DHA Supplements on Infant Development

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

IMSS General Hospital I

Cuernavaca, Morelos, Mexico

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18-22 weeks pregnant (based on last menstrual period)
  • 18 - 35 years old
  • Resident of Cuernavaca who intends to deliver at the IMSS General Hospital I and remain in the area for the 2 years following recruitment
  • Intends to predominantly breastfeed infant until 3 months of age
  • Agrees to participate with informed consent

Exclusion criteria

  • High risk pregnancy: If documented in the clinical record at recruitment and will include history and prevalence of abruptio placentae, any serious bleeding episode in the current pregnancy, gestational diabetes, pregnancy induced hypertension, maternal toxoplasmosis infection during pregnancy, coagulation disorders, thrombocytopenia or chronic vascular, renal or systemic disease and drug use.
  • Lipid metabolism (hyperlipidemia) and/or absorption disorders
  • Regular intake of fish oil or DHA supplements during pregnancy
  • Chronic use of medication for illnesses like epilepsy

Treatment and study plan

DHA

Dietary Supplement

400 mg/d of docosahexanoic acid (DHA) during pregnancy

Other names: Martek Algal DHA

Placebo

Dietary Supplement

2 tablets daily during pregnancy

Other names: Specially formulated by Martek Biosciences

Primary outcomes

  1. Birth size

    Time frame: Birth

    Birth size will be determined by measuring the newborn, a baby's length is measured from the top of their head to the bottom of one of their heels.

  2. Gestational age

    Time frame: Birth

    Gestational age is measured in weeks, from the first day of the woman's last menstrual cycle to the current date.

  3. Changes in visual evoked potentials

    Time frame: 3 and 6 months of age

    Visual evoked potential (VEP) is an electrical signal emanated from the brain while a visual stimulus is presented to the subject in a time locked manner. The VEP can be used as a diagnostic tool to detect ocular diseases in patients with visually impaired. VEP response can also be used to detect eye diseases like glaucoma, diabetic retinopathy, multiple sclerosis, ocular hypertension, loss of peripheral (side) vision, macular degeneration and color blindness.

  4. Changes in infant weight

    Time frame: Birth, months 1, 3, 6, 9, 12, 18, 24, 36 and at 4 and 5 years of age

    Infant weight is measured in kilograms (kg) and weight is measured in the hospital and at all check-ups.

  5. Changes in infant height

    Time frame: Birth, months 1, 3, 6, 9, 12, 18, 24, 36 and at 4 and 5 years of age

    Infants will be measured in the hospital and at all check-ups. Height is measured in centimeters (cm).

  6. Changes In infant head circumference

    Time frame: Birth, months 1, 3, 6, 9, 12, 18, 24, 36 and at 4 and 5 years of age

    Head circumference or OFC [occipital frontal circumference] is measured over the most prominent part on the back of the head (occiput) and just above the eyebrows (supraorbital ridges). This can be translated to mean the largest circumference of the head. Head circumference is measured in centimeters (cm).

  7. Changes in auditory evoked potentials

    Time frame: 1 and 3 months of age

    A brainstem auditory evoked response (BAER) test measures how the brain processes the sounds a person hears. The BAER test records the subject's brainwaves in response to clicks or other audio tones that are played for them.

  8. Changes in child development score

    Time frame: 1, 1.5 and 5 years of age

    The Bayley Scales of Infant Development -II are used to assess child development during the first two years of life while The McCarthy Scales of Children's Abilities (MSCA) is a psychological instrument for young children that measures cognitive ability in six domain areas: Verbal, Perceptual-Performance, Quantitative, General Cognitive, Memory, and Motor at age 5 y.

  9. Changes in Hearts and Flowers Stroop Test

    Time frame: 5 years of age

    This tests working memory, response inhibition, and task switching/cognitive flexibility . The task requires participants to press a response button that is either on the same side (congruent) or opposite side (incongruent) of an image. When children see an image of a heart, they are instructed to press the corresponding directional arrow button on a keyboard. When children see an image of a flower, they are instructed to press the opposite directional arrow button on the keyboard . The task consists of three separate levels that contain only congruent trials (12 trials total), only incongruent trials (12 trials total), and mixed congruent and incongruent trials respectively (33 trials total). Images are presented on a computer monitor. Before both the congruent and incongruent trial blocks, a training period is administered which consists of 5 trials. The child is unable to advance to the next question until they respond correctly.

Secondary outcomes

  1. Changes Immune function

    Time frame: first 6 months of life

  2. Changes in Morbidity

    Time frame: Birth, months 1, 3, 6, 9, 12, 18, 24, 36 and at 4 and 5 years of age

    Changes in morbidity (health) factors will be assessed.

  3. Cognitive outcomes at age 7 years of age

    Time frame: At 7 year follow up

    The cognitive intelligence test WAIS-IV offers compound scores that reflect the intellectual functioning of 4 cognitive areas (verbal understanding, perceptive reasoning, working memory and processing speed). It also offers a compound score that reflects intellectual aptitude in general (Intelligence quotient).

Sponsors and collaborators

Lead sponsor

Emory University

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • Instituto Mexicano del Seguro Social
  • Instituto Nacional de Salud Publica, Mexico

Registry information

Important dates

Study start
2005
Primary completion
2013
Study completion
2014
First posted
Mar 28, 2008
Registry last updated
Jun 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.