Effects of Prenatal DHA Supplements on Infant Development - Full Text View

Sponsor:	Emory University
Collaborators:	Instituto Nacional de Salud Publica, Mexico Instituto Mexicano del Seguro Social
Information provided by:	Emory University
ClinicalTrials.gov Identifier:	NCT00646360

Purpose

Our research is about the significance of polyunsaturated fatty acids (PUFAs) for human development. Specifically, we 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 18 mo 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 development (visual and auditory evoked potentials, visual attention and Bayley scales of infant development) are measured at birth, 1, 3, 6, 9, 12 and 18 mo 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.

Condition	Intervention	Phase
Pregnancy	Dietary Supplement: DHA Dietary Supplement: Placebo	Phase III

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Effects of Prenatal DHA Supplements on Infant Development

Resource links provided by NLM:

MedlinePlus related topics: Dietary Supplements Diets Prenatal Care

U.S. FDA Resources

Further study details as provided by Emory University:

Primary Outcome Measures:

Birth size and gestational age [ Time Frame: Birth ] [ Designated as safety issue: No ]
Infant growth and development in the first 18 mo of life [ Time Frame: first 18 mo of life ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Immune function and morbidity [ Time Frame: first 6 mo of life ] [ Designated as safety issue: No ]

Enrollment:	1094
Study Start Date:	February 2005
Estimated Study Completion Date:	January 2009
Primary Completion Date:	July 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental DHA	Dietary Supplement: DHA 400 mg/d of docosahexanoic acid (DHA) during pregnancy
2: Placebo Comparator	Dietary Supplement: Placebo 2 tablets daily during pregnancy

Eligibility

Ages Eligible for Study:	18 Years to 35 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00646360

Locations

Mexico, Morelos
IMSS General Hospital I
Cuernavaca, Morelos, Mexico

Sponsors and Collaborators

Emory University

Instituto Nacional de Salud Publica, Mexico

Instituto Mexicano del Seguro Social

Investigators

Principal Investigator:

Usha Ramakrishnan, Ph.D.

Emory University

More Information

No publications provided

Responsible Party:	Emory University ( Usha Ramakrishnan )
Study ID Numbers:	028-2004, HD43099
Study First Received:	March 25, 2008
Last Updated:	March 25, 2008
ClinicalTrials.gov Identifier:	NCT00646360 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Emory University:

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

ClinicalTrials.gov processed this record on November 20, 2009