Clinical trial NCT00646360: Effects of Prenatal DHA Supplements on Infant Development
Official title: Effects of Prenatal DHA Supplements on Infant Development
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy
Keywords: birth size, gestational age, development, child growth,
prenatal nutrition, DHA
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: Instituto Nacional de Salud Publica, Mexico
name: Instituto Mexicano del Seguro Social
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2008-03-28
Enrollment: 1094
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Birth size
timeFrame: Birth
measure: Gestational age
timeFrame: Birth
measure: Changes in visual evoked potentials
timeFrame: 3 and 6 months of age
measure: Changes in infant weight
timeFrame: Birth, months 1, 3, 6, 9, 12, 18, 24, 36 and at 4 and 5 years of age
measure: Changes in infant height
timeFrame: Birth, months 1, 3, 6, 9, 12, 18, 24, 36 and at 4 and 5 years of age
measure: Changes In infant head circumference
timeFrame: Birth, months 1, 3, 6, 9, 12, 18, 24, 36 and at 4 and 5 years of age
measure: Changes in auditory evoked potentials
timeFrame: 1 and 3 months of age
measure: Changes in child development score
timeFrame: 1, 1.5 and 5 years of age
measure: Changes in Hearts and Flowers Stroop Test
timeFrame: 5 years of age
Secondary outcomes:
measure: Changes Immune function
timeFrame: first 6 months of life
measure: Changes in Morbidity
timeFrame: Birth, months 1, 3, 6, 9, 12, 18, 24, 36 and at 4 and 5 years of age
measure: Cognitive outcomes at age 7 years of age
timeFrame: At 7 year follow up
Other outcomes:
Locations:
city: Cuernavaca
country: Mexico
facility: IMSS General Hospital I
state: Morelos
Study officials:
affiliation: Emory University
name: Usha Ramakrishnan, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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