Effects of Prenatal DHA Supplements on Infant Development

Pregnancy Clinical Trial

Official title: Effects of Prenatal DHA Supplements on Infant Development

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Pregnancy

• NCT number: NCT00646360
• Study type: Interventional
• Source: Emory University
• Status: Completed
• Phase: N/A
• Start date: February 2005
• Completion date: August 16, 2014