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Effects of Prenatal DHA Supplements on Infant Development

NCT00646360 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1094

Last updated 2022-06-07

No results posted yet for this study

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.

Conditions

  • Pregnancy

Interventions

DIETARY_SUPPLEMENT

DHA

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

DIETARY_SUPPLEMENT

Placebo

2 tablets daily during pregnancy

Sponsors & Collaborators

  • Instituto Nacional de Salud Publica, Mexico

    collaborator OTHER

  • Instituto Mexicano del Seguro Social

    collaborator OTHER_GOV

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • Emory University

    lead OTHER

Principal Investigators

  • Usha Ramakrishnan, Ph.D. · Emory University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2005-02-28
Primary Completion
2013-01-03
Completion
2014-08-16

Countries

  • Mexico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00646360 on ClinicalTrials.gov