Status:
COMPLETED
Effect of Omega-3 Supplementation During Pregnancy on Regulation of Stress
Lead Sponsor:
University of Chicago
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Healthy Pregnant Women
Eligibility:
FEMALE
20-34 years
Phase:
NA
Brief Summary
This will be the first study of the effect of essential fatty acid supplementation in pregnant women living in inner-city poverty on the stress response system during pregnancy. The investigators prop...
Detailed Description
Significance: Pregnant women living in poverty often experience chronic stress, and consequently higher levels of stress hormones. In utero exposure to high levels of stress hormones can negatively af...
Eligibility Criteria
Inclusion
- African American race
- age between 20 and 34 years
- 16-21 weeks gestation
- household receipt of public assistance (e.g., Medicaid insurance) due to -low-income
- low levels of DHA consumption as defined as less than two fish servings per week.
Exclusion
- known medical complications (e.g., gestational diabetes, pre-eclampsia), -regular use of steroid medications
- alcohol use
- cigarettes or use of illegal substances (by maternal report)
- use of blood thinners or anti-coagulants
- use of psychotropic medications
- Body Mass Index \>40
- allergy to iodine and/or soy.
Key Trial Info
Start Date :
December 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT01158976
Start Date
December 1 2009
End Date
June 1 2013
Last Update
May 30 2018
Active Locations (2)
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1
University of Chicago
Chicago, Illinois, United States, 60637
2
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213