Effects of Prenatal DHA Supplements on Infant Development

NCT ID: NCT00646360

Last Updated: 2022-06-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1094 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-02-28
• Study Completion Date: 2014-08-16

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.

Conditions

Pregnancy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

DHA arm

Docosahexonic acid (DHA) (400 mg/day). 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.

Group Type: EXPERIMENTAL

DHA

Intervention Type: DIETARY_SUPPLEMENT

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

Placebo arm

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

2 tablets daily during pregnancy

Interventions

DHA

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

Intervention Type: DIETARY_SUPPLEMENT

Placebo

2 tablets daily during pregnancy

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Martek Algal DHA; Specially formulated by Martek Biosciences

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Instituto Nacional de Salud Publica, Mexico

OTHER

Sponsor Role: collaborator

Instituto Mexicano del Seguro Social

OTHER_GOV

Sponsor Role: collaborator

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

NIH

Sponsor Role: collaborator

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Usha Ramakrishnan

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Usha Ramakrishnan, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

IMSS General Hospital I

Cuernavaca, Morelos, Mexico

Countries

Mexico

References

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Other Identifiers

5R01HD043099

Identifier Type: NIH

Identifier Source: secondary_id

View Link

5R03HD087606

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00024976

Identifier Type: -

Identifier Source: org_study_id