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Effects of Prenatal DHA Supplements on Infant Development

Effects of Prenatal DHA Supplements on Infant Development

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00646360
Enrollment
1094
Registered
2008-03-28
Start date
2005-02-28
Completion date
2014-08-16
Last updated
2022-06-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pregnancy

Keywords

birth size, gestational age, development, child growth,, prenatal nutrition, DHA

Brief 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.

Interventions

DIETARY_SUPPLEMENTDHA

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

DIETARY_SUPPLEMENTPlacebo

2 tablets daily during pregnancy

Sponsors

Instituto Nacional de Salud Publica, Mexico
CollaboratorOTHER
Instituto Mexicano del Seguro Social
CollaboratorOTHER_GOV
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
CollaboratorNIH
Emory University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 35 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Changes in Hearts and Flowers Stroop Test5 years of ageThis 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.
Changes In infant head circumferenceBirth, months 1, 3, 6, 9, 12, 18, 24, 36 and at 4 and 5 years of ageHead 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).
Changes in auditory evoked potentials1 and 3 months of ageA 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.
Changes in child development score1, 1.5 and 5 years of ageThe 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.
Birth sizeBirthBirth 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.
Gestational ageBirthGestational age is measured in weeks, from the first day of the woman's last menstrual cycle to the current date.
Changes in visual evoked potentials3 and 6 months of ageVisual 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.
Changes in infant weightBirth, months 1, 3, 6, 9, 12, 18, 24, 36 and at 4 and 5 years of ageInfant weight is measured in kilograms (kg) and weight is measured in the hospital and at all check-ups.
Changes in infant heightBirth, months 1, 3, 6, 9, 12, 18, 24, 36 and at 4 and 5 years of ageInfants will be measured in the hospital and at all check-ups. Height is measured in centimeters (cm).

Secondary

MeasureTime frameDescription
Changes in MorbidityBirth, months 1, 3, 6, 9, 12, 18, 24, 36 and at 4 and 5 years of ageChanges in morbidity (health) factors will be assessed.
Cognitive outcomes at age 7 years of ageAt 7 year follow upThe 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).
Changes Immune functionfirst 6 months of life

Countries

Mexico

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 20, 2026