Clinical trial NCT01158976: Effect of Omega-3 Supplementation During Pregnancy on Regulation of Stress
Official title: Impact of Omega-3 Intake During Pregnancy on Maternal Stress and Infant Outcome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Pregnant Women
Lead sponsor: University of Chicago
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2010-07-08
Enrollment: 64
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 34
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This will be the first study of the effect of essential fatty acid supplementation in pregnant women living in inner-city poverty on the stress response system during pregnancy. The investigators proposed that essential fatty acid supplementation will be associated with reductions in the experience of stress, more modulated hormonal response to stress, and more optimal regulation of emotion and attention in the infant, even within the context inner-city poverty.

Detailed description: Significance: Pregnant women living in poverty 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 later, the infant's capacity for emotion and behavioral regulation. In this proposal we describe a developing program of research 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. Aims: The goals of the proposed study are to explore whether DHA supplementation during pregnancy is associated with 1) a reduction in maternal perceived stress during pregnancy; 2) a more modulated maternal cortisol response to a stress stimulus during pregnancy, and 3) more optimal regulation of emotion and behavior in the infant. Approach: Sixty-five pregnant women living in inner-city poverty, who consume less than two servings of fish per week, will be randomly assigned to receive 450 mg/daily of DHA or placebo beginning at 16-20 weeks gestation through the end of pregnancy. Perceived stress, pregnancy related stress, stressful life events, anxiety, and depression will be assessed at baseline and at 24, 30, and 36 weeks of pregnancy and at 4 months post-partum. DHA levels will be assessed at baseline and at 36 weeks of pregnancy. Cortisol response to the Trier Social Stress Test will be measured at baseline, 24, and 30 weeks. At 4 months post-partum infant temperament, cognitive development and stress reactivity will be assessed in the laboratory. Investigators: This proposal stems from an National Institute of Mental Health R21 Translational Science Network on prenatal stress and mental health outcomes in the offspring. Three members of that network, Drs. Keenan, Carter, and Glover, are all funded investigators in the area of prenatal stress and child mental health, which is a prioritized area of exploratory research that could directly impact clinical care. They are collaborating on the present application. Innovation: This will be the first randomized controlled study of the effect of DHA supplementation on stress response in pregnant women living in inner-city poverty, and the first study of maternal DHA supplementation on emotion and stress regulation in their infants. Relevance: If DHA supplementation is associated with reductions in perceived stress, more modulated maternal cortisol response to stress, and more optimal emotional and behavioral regulation in the infant, even within the context inner-city poverty, then a comprehensive program of research on the mechanisms by which these associations evolve and the potential for broad-based prevention of poor developmental outcomes among children born to women living in poverty can be launched.

Eligibility criteria: Inclusion Criteria:

* African American race
* age between 20 and 34 years
* 16-21 weeks gestation
* household receipt 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:

* known medical complications (e.g., gestational diabetes, pre-eclampsia), -regular use of steroid medications
* alcohol use
* cigarettes or use of illegal substances (by maternal report)
* use of blood thinners or anti-coagulants
* use of psychotropic medications
* Body Mass Index \>40
* allergy to iodine and/or soy.

Primary outcomes:
measure: Maternal Cortisol Levels
timeFrame: Baseline (pre-stressor)
measure: Maternal Cortisol Levels
timeFrame: 20 minutes post-stressor
measure: Maternal Cortisol Levels
timeFrame: 45 minutes post stressor
measure: Infant Cortisol Levels
timeFrame: 4 months post-partum
measure: Infant Cortisol Levels
timeFrame: 4 months post-partum
measure: Infant Cortisol Levels
timeFrame: 4 months post-partum
Secondary outcomes:
measure: Maternal Depression Symptoms
timeFrame: 16-21 weeks gestation
measure: Maternal Depression Symptoms
timeFrame: 24 weeks
measure: Maternal Depression Symptoms
timeFrame: 30 weeks gestation
measure: Maternal Perceived Stress Scale (PSS) Score
timeFrame: Baseline: 16 - 21 weeks
measure: Maternal Perceived Stress Scale Score
timeFrame: 24 weeks gestation
measure: Maternal Perceived Stress Scale Score
timeFrame: 30 weeks gestation
measure: Infant Birth Weight
timeFrame: Time of birth, total sample range: 27.60 to 41.60 weeks gestation
measure: Percentage of Infants Who Had a 1-minute Apgar Scores of 9
timeFrame: Time of birth, total sample range: 27.60 to 41.60 weeks gestation
measure: Gestational Age (GA)
timeFrame: Time of birth, total sample range: 27.60 to 41.60 weeks gestation
measure: Infant's Receptive Communication Scaled Score
timeFrame: 3 months old
measure: Infant's Expressive Communication Scaled Score
timeFrame: At approximately 3 months of age
measure: Infant's Fine Motor Skills Scaled Score
timeFrame: Approximately 3 months of age
measure: Infant's Gross Motor Skills Scaled Score
timeFrame: Approximately 3 months of age
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
Study officials:
References:
citation: Keenan K, Hipwell AE, Bortner J, Hoffmann A, McAloon R. Association between fatty acid supplementation and prenatal stress in African Americans: a randomized controlled trial. Obstet Gynecol. 2014 Dec;124(6):1080-1087. doi: 10.1097/AOG.0000000000000559.