Effect of Omega-3 Supplementation During Pregnancy on Regulation of Stress (NAPS)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Chicago
ClinicalTrials.gov Identifier:
NCT01158976
First received: June 28, 2010
Last updated: September 4, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention
Healthy Pregnant Women
Dietary Supplement: Docosahexanoic Acid
Other: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Impact of Omega-3 Intake During Pregnancy on Maternal Stress and Infant Outcome

Resource links provided by NLM:


Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • Maternal cortisol response to a laboratory stressor [ Time Frame: Baseline: 17-20 weeks gestation ] [ Designated as safety issue: No ]
    Maternal stress regulation

  • Maternal cortisol response to a laboratory stressor [ Time Frame: 24 weeks gestation ] [ Designated as safety issue: No ]
    Maternal stress regulation

  • Maternal cortisol response to a laboratory stressor [ Time Frame: 30 weeks gestation ] [ Designated as safety issue: No ]
    Maternal stress regulation

  • DHA Levels [ Time Frame: 36 weeks ] [ Designated as safety issue: No ]
    Amount of DHA in blood

  • Infant cortisol response to the Still-Face paradigm [ Time Frame: 4 months post-partum ] [ Designated as safety issue: No ]
    Infant stress regulation


Secondary Outcome Measures:
  • Maternal anxiety and depression [ Time Frame: Baseline: 17-21 weeks gestation ] [ Designated as safety issue: No ]
    depression and anxiety symptoms

  • Maternal anxiety and depression [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    depression and anxiety symptoms

  • Maternal anxiety and depression [ Time Frame: 30 weeks gestation ] [ Designated as safety issue: No ]
    anxiety and depression symptoms

  • Maternal anxiety and depression [ Time Frame: 36 weeks ] [ Designated as safety issue: No ]
    anxiety and depression symptoms


Enrollment: 66
Study Start Date: December 2009
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: DHA supplementation Dietary Supplement: Docosahexanoic Acid
450 mg DHA daily beginning at 16-21 weeks gestation and continuing up to time of delivery
Other Name: Nordic Naturals ProDHA
Placebo Comparator: Soybean Oil Other: Placebo
soybean oils with strawberry flavoring

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

Ages Eligible for Study:   20 Years to 34 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01158976

Locations
United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
United States, Pennsylvania
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Chicago
  More Information

No publications provided

Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT01158976     History of Changes
Other Study ID Numbers: 09-190A, R21HD058269
Study First Received: June 28, 2010
Last Updated: September 4, 2013
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on July 20, 2014