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Effects of Prenatal DHA Supplements on Infant Development

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00646360
Recruitment Status : Active, not recruiting
First Posted : March 28, 2008
Last Update Posted : December 30, 2020
Instituto Nacional de Salud Publica, Mexico
Instituto Mexicano del Seguro Social
Information provided by (Responsible Party):
Usha Ramakrishnan, Emory University

Brief Summary:
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 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 mo 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.

Condition or disease Intervention/treatment Phase
Pregnancy Dietary Supplement: DHA Dietary Supplement: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1094 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effects of Prenatal DHA Supplements on Infant Development
Study Start Date : February 2005
Actual Primary Completion Date : July 2007
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1
Docosahexonic acid (400 mg/day)
Dietary Supplement: DHA
400 mg/d of docosahexanoic acid (DHA) during pregnancy
Other Name: Martek Algal DHA

Placebo Comparator: 2 Dietary Supplement: Placebo
2 tablets daily during pregnancy
Other Name: Specially formulated by Martek Biosciences

Primary Outcome Measures :
  1. Birth size and gestational age [ Time Frame: Birth ]
  2. Infant growth and development in the first 5 years of life [ Time Frame: first 5 years of life ]

Secondary Outcome Measures :
  1. Immune function and morbidity [ Time Frame: first 6 mo of life ]
  2. Cognitive outcomes at age 7 y

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00646360

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IMSS General Hospital I
Cuernavaca, Morelos, Mexico
Sponsors and Collaborators
Emory University
Instituto Nacional de Salud Publica, Mexico
Instituto Mexicano del Seguro Social
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Principal Investigator: Usha Ramakrishnan, Ph.D. Emory University
Publications automatically indexed to this study by Identifier (NCT Number):

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Responsible Party: Usha Ramakrishnan, Professor, Emory University Identifier: NCT00646360    
Other Study ID Numbers: IRB00024976
First Posted: March 28, 2008    Key Record Dates
Last Update Posted: December 30, 2020
Last Verified: December 2020
Keywords provided by Usha Ramakrishnan, Emory University:
birth size, gestational age, development, child growth,
prenatal nutrition, DHA