Clinical trial NCT02647723: Improving Maternal and Child Health Through Prenatal Fatty Acid Supplementation
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Pregnancy
Child Development
Keywords: Omega-3
Fatty acid
docosahexaenoic
Pregnant
neurodevelopment
stress
urban
african-american
supplement
nutrition
mental health
Lead sponsor: University of Chicago
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
name: University of Pittsburgh
First posted: 2016-01-06
Enrollment: 168
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 34
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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

Eligibility criteria: 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

Primary outcomes:
measure: Average Change in Perceived Stress Scale (PSS) Score From Visit 1 to Visit 4
timeFrame: 16 months
measure: Average Change in Perceived Stress Scale (PSS) Score From Visit 1 to Visit 3
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago Medicine
state: Illinois
Study officials:
affiliation: University of Chicago
name: Kathryn Keenan, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: