Improving Maternal and Child Health Through Prenatal Fatty Acid Supplementation

Pregnancy Clinical Trial

— NAPS  

Official 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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02647723
• Other study ID #: IRB15-0392
• Secondary ID: R01HD084586
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 2016
• Est. completion date: January 2022

Study information

• Verified date: June 2021
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 161
• Est. completion date: January 2022
• Est. primary completion date: January 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 34 Years

Eligibility

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

Related Conditions & MeSH terms

• Child Development
• Pregnancy

Intervention

Dietary Supplement:
• DHA
2 dietary supplement gel capsules providing 450 mg of DHA twice daily by oral intake for 24 weeks
• Sugar pill
2 dietary supplement gel capsules providing 450 mg of soybean oil twice daily by oral intake for 24 weeks

Locations

Country	Name	City	State
United States	University of Chicago Medicine	Chicago	Illinois

Sponsors (3)

Lead Sponsor	Collaborator
University of Chicago	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), University of Pittsburgh

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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