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NCT Number: NCT02647723

Improving Maternal and Child Health Through Prenatal Fatty Acid Supplementation

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.

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This study is active but is not currently recruiting participants.

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Key information

Age range

18 year–34 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Chicago Medicine

Chicago, Illinois, 60637, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age between 18 and 34
  • Household recipient 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 criteria

  • Reports of known medial complications
  • Regular use of steroid medications, alcohol, cigarettes, or illegal substances (by maternal report)
  • Use of blood thinners or anti-coagulants
  • Use of psychotropic medications
  • Allergy to iodine and/or soy

Treatment and study plan

DHA

Dietary Supplement

2 dietary supplement gel capsules providing 450 mg of DHA twice daily by oral intake for 24 weeks

Other names: Omega-3, docosahexaenoic acid

Sugar Pill

Dietary Supplement

2 dietary supplement gel capsules providing 450 mg of soybean oil twice daily by oral intake for 24 weeks

Other names: soybean oil

Primary outcomes

  1. Average Change in Perceived Stress Scale (PSS) Score From Visit 1 to Visit 4

    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

  2. Average Change in Perceived Stress Scale (PSS) Score From Visit 1 to Visit 3

    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

Sponsors and collaborators

Lead sponsor

University of Chicago

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2027
Study completion
2027
First posted
Jan 6, 2016
Registry last updated
Jul 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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