University of Chicago Medicine
Chicago, Illinois, 60637, United States
NCT Number: NCT02647723
The purpose of the study is to test whether nutritional supplementation during pregnancy is associated with 1) improved maternal health during pregnancy; 2) improved infant birth and neurodevelopmental outcomes, and 3) whether the association between nutritional supplementation during pregnancy and infant outcomes is partially mediated by reductions in maternal perceived stress and stress reactivity during pregnancy.
This study is active but is not currently recruiting participants.
Notify Me18 year–34 year
Female
Interventional
Not applicable
Chicago, Illinois, 60637, United States
Low-income pregnant women often experience chronic stress and consequently higher levels of stress hormones. In utero exposure to high levels of stress hormones can negatively affect the developing fetus and the infant's capacity for emotion and behavioral regulation. This program of research is designed to reduce the negative impact of prenatal stress on infant health and development via nutritional supplementation of docosahexaenoic acid (DHA) during pregnancy. DHA is a long-chain polyunsaturated fatty acid member of the omega-3 fatty acid family. DHA is found in its highest concentrations in neural cell membranes, affecting receptor function, neurotransmitter uptake, and signal transmission. There is growing evidence that low levels of dietary DHA intake are associated with suboptimal response to stress and that DHA supplementation can modulate stress response.
One hundred sixty-two pregnant women will be randomly assigned to receive 450 mg/daily of DHA or placebo beginning at 9-12 weeks of gestation through the end of pregnancy. Perceived stress, stressful life events, anxiety, and depression, inflammatory markers, DHA levels and response to a laboratory stressor will be assessed at baseline and at 24, 30, and 36 weeks of pregnancy. Neonatal outcomes (e.g., gestational age, birth weight, delivery complications) will be collected from medical records, and infant neurodevelopmental outcomes and stress reactivity will be assessed at 1, 4 and 9 months of age. Coded data will be analyzed by the Investigators at University of Chicago and University of Pittsburgh
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
2 dietary supplement gel capsules providing 450 mg of DHA twice daily by oral intake for 24 weeks
Other names: Omega-3, docosahexaenoic acid
2 dietary supplement gel capsules providing 450 mg of soybean oil twice daily by oral intake for 24 weeks
Other names: soybean oil
Time frame: 16 months
Will be assessed at baseline and at 24, 30, and 36 weeks of pregnancy, and at 1, 4 and 9 months after giving birth.
The Perceived Stress Scale score is obtained by summing the points awarded to the 10 items and it ranges from 0 to 40 where:
0-13 - Low stress 14-26 - Moderate stress 27-40 - High perceived stress
Time frame: 12 months
Will be assessed at baseline and at 24, 30, and 36 weeks of pregnancy, and at 1, 4 and 9 months after giving birth.
The Perceived Stress Scale score is obtained by summing the points awarded to the 10 items and it ranges from 0 to 40 where:
0-13 - Low stress 14-26 - Moderate stress 27-40 - High perceived stress
University of Chicago
Other
Improving Maternal and Child Health Through Prenatal Fatty Acid Supplementation: A Randomized Controlled Study in African American Women Living in Low-income Urban Environments
Acronym: NAPS
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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