Overview

This trial is active, not recruiting.

Condition pregnancy
Treatments dha, placebo
Phase phase 3
Sponsor Emory University
Collaborator Instituto Nacional de Salud Publica, Mexico
Start date February 2005
End date July 2007
Trial size 1094 participants
Trial identifier NCT00646360, HD43099, IRB00024976

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose prevention
Arm
(Experimental)
Docosahexonic acid (400 mg/day)
dha Martek Algal DHA
400 mg/d of docosahexanoic acid (DHA) during pregnancy
(Placebo Comparator)
placebo Specially formulated by Martek Biosciences
2 tablets daily during pregnancy

Primary Outcomes

Measure
Birth size and gestational age
time frame: Birth
Infant growth and development in the first 5 years of life
time frame: first 5 years of life

Secondary Outcomes

Measure
Immune function and morbidity
time frame: first 6 mo of life

Eligibility Criteria

Female participants from 18 years up to 35 years old.

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

Additional Information

Official title Effects of Prenatal DHA Supplements on Infant Development
Principal investigator Usha Ramakrishnan, Ph.D.
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by Emory University.