Improving Maternal and Child Health Through Prenatal Fatty Acid Supplementation (NAPS)

Improving Maternal and Child Health Through Prenatal Fatty Acid Supplementation: A Randomized Controlled Study in African American Women Living in Low-income Urban Environments

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Pregnancy; Child Development
• Intervention / Treatment: Dietary supplement: DHA; Dietary supplement: Sugar pill

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 161
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60637
      • University of Chicago Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 34 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Oral supplement for pregnant women; 450 mg/daily of DHA beginning at 10-16 weeks of gestation through the end of pregnancy	Dietary supplement: DHA; 2 dietary supplement gel capsules providing 450 mg of DHA twice daily by oral intake for 24 weeks; Other Names: docosahexaenoic acid; Omega-3
Placebo Comparator: Sugar pill; 450 mg/daily of sugar pill beginning at 10-16 weeks of gestation through the end of pregnancy	Dietary supplement: Sugar pill; 2 dietary supplement gel capsules providing 450 mg of soybean oil twice daily by oral intake for 24 weeks; Other Names: soybean oil

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average change in Perceived Stress Scale (PSS) score	Will be assessed at baseline and at 24, 30, and 36 weeks of pregnancy, and at 1, 4 and 9 months after giving birth	16 months

Collaborators and Investigators

• Sponsor: University of Chicago
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); University of Pittsburgh
• Investigators: Principal Investigator: Kathryn Keenan, Ph.D, University of Chicago

Study record dates

Study Major Dates

• Study Start: January 1, 2016
• Primary Completion (Anticipated): January 1, 2022
• Study Completion (Anticipated): January 1, 2022

Study Registration Dates

• First Submitted: January 4, 2016
• First Submitted That Met QC Criteria: January 4, 2016
• First Posted (Estimate): January 6, 2016

Study Record Updates

• Last Update Posted (Actual): June 18, 2021
• Last Update Submitted That Met QC Criteria: June 16, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: nutrition; mental health; stress; Omega-3; supplement; urban; neurodevelopment; Pregnant; Fatty acid; docosahexaenoic; african-american
• Other Study ID Numbers: IRB15-0392; R01HD084586 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO