Status:
COMPLETED
Effects of Prenatal DHA Supplements on Infant Development
Lead Sponsor:
Emory University
Collaborating Sponsors:
Instituto Nacional de Salud Publica, Mexico
Instituto Mexicano del Seguro Social
Conditions:
Pregnancy
Eligibility:
FEMALE
18-35 years
Phase:
NA
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) su...
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) supplementa...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
February 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 16 2014
Estimated Enrollment :
1094 Patients enrolled
Trial Details
Trial ID
NCT00646360
Start Date
February 1 2005
End Date
August 16 2014
Last Update
June 7 2022
Active Locations (1)
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1
IMSS General Hospital I
Cuernavaca, Morelos, Mexico