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Completed

NCT Number: NCT01158976

Effect of Omega-3 Supplementation During Pregnancy on Regulation of Stress

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.

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Key information

Conditions

Healthy Pregnant Women

Age range

20 year–34 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Chicago, Chicago, Illinois, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Docosahexanoic Acid

Dietary Supplement

450 mg DHA daily beginning at 16-21 weeks gestation and continuing up to time of delivery

Other names: Nordic Naturals ProDHA

Placebo

Other

soybean oils with strawberry flavoring

Primary outcomes

  1. Maternal Cortisol Levels

    Time frame: Baseline (pre-stressor)

    Maternal stress regulation at 30 weeks gestation

  2. Maternal Cortisol Levels

    Time frame: 20 minutes post-stressor

    Maternal stress regulation at 30 weeks gestation

  3. Maternal Cortisol Levels

    Time frame: 45 minutes post stressor

    Maternal stress regulation at 30 weeks gestation

  4. Infant Cortisol Levels

    Time frame: 4 months post-partum

    Infant cortisol response to the Still-Face paradigm before stressor

  5. Infant Cortisol Levels

    Time frame: 4 months post-partum

    Infant cortisol response to the Still-Face paradigm 20 minutes post-stressor

  6. Infant Cortisol Levels

    Time frame: 4 months post-partum

    Infant cortisol response to the Still-Face paradigm 45 mins post-stressor

Secondary outcomes

  1. Maternal Depression Symptoms

    Time frame: 16-21 weeks gestation

    Maternal depression symptoms at 16 to 24 weeks gestation, as measured by the Edinburgh Postnatal Depression Scale, a 10-item measure designed to assess pre- and postnatal depression.

    Maximum score: 30 Minimum score: 0 Possible Depression: 10 or greater Mothers who score above 13 are likely to be suffering from a depressive illness of varying severity.

  2. Maternal Depression Symptoms

    Time frame: 24 weeks

    Maternal depression symptoms at 24 weeks gestation as measured by the Edinburgh Postnatal Depression Scale, a 10-item measure designed to assess pre- and postnatal depression.

    Maximum score: 30 Minimum score: 0 Possible Depression: 10 or greater Mothers who score above 13 are likely to be suffering from a depressive illness of varying severity.

  3. Maternal Depression Symptoms

    Time frame: 30 weeks gestation

    Maternal depression symptoms at 30 weeks gestation, as measured by the Edinburgh Postnatal Depression Scale, a 10-item measure designed to assess pre- and postnatal depression.

    Maximum score: 30 Minimum score: 0 Possible Depression: 10 or greater Mothers who score above 13 are likely to be suffering from a depressive illness of varying severity.

  4. Maternal Perceived Stress Scale (PSS) Score

    Time frame: Baseline: 16 - 21 weeks

    Perceived stress as measured by the Perceived Stress Scale (Cohen et al, 1983) at baseline. There are 10 questions in this scale and they all refer to typical life stressors.

    Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress.

    • Scores ranging from 0-13 would be considered low stress.
    • Scores ranging from 14-26 would be considered moderate stress.
    • Scores ranging from 27-40 would be considered high perceived stress

  5. Maternal Perceived Stress Scale Score

    Time frame: 24 weeks gestation

    Perceived stress as measured by the Perceived Stress Scale (Cohen et al, 1983) at 24 weeks gestation.

    There are 10 questions in this scale and they all refer to typical life stressors.

    Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress.

    • Scores ranging from 0-13 would be considered low stress.
    • Scores ranging from 14-26 would be considered moderate stress.
    • Scores ranging from 27-40 would be considered high perceived stress

  6. Maternal Perceived Stress Scale Score

    Time frame: 30 weeks gestation

    Perceived stress as measured by the Perceived Stress Scale (Cohen et al, 1983) at 30 weeks gestation.

    There are 10 questions in this scale and they all refer to typical life stressors.

    Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress.

    • Scores ranging from 0-13 would be considered low stress.
    • Scores ranging from 14-26 would be considered moderate stress.
    • Scores ranging from 27-40 would be considered high perceived stress

  7. Infant Birth Weight

    Time frame: Time of birth, total sample range: 27.60 to 41.60 weeks gestation

    Weight of infant

  8. Percentage of Infants Who Had a 1-minute Apgar Scores of 9

    Time frame: Time of birth, total sample range: 27.60 to 41.60 weeks gestation

    Percentage of infants who had a 1-minute Apgar scores of 9 Sub scores from 5 categories( Breathing effort, Heart rate, Muscle tone, Reflexes, Skin color) are added together Score range: 1-10 A higher score is better where 7,8,9 are normal

  9. Gestational Age (GA)

    Time frame: Time of birth, total sample range: 27.60 to 41.60 weeks gestation

    Gestational Age at time of birth Total sample range: 27.60 to 41.60 weeks Below 37 considered premature Mothers typically induced after 41 weeks due to increased pregnancy risks after this time

  10. Infant's Receptive Communication Scaled Score

    Time frame: 3 months old

    Scaled Score on Receptive Communication subscale of Bayley Scale for Infant Development that determines how well a child recognizes sounds and how much a child understands spoken words and directions compared to a group of children within the same age range from across the United States. Subscale consists of 49 items. Child'e scaled score is calculated from total raw scores.

    Scaled score range: 1 - 12 Lower scores indicate more developmental delay.

  11. Infant's Expressive Communication Scaled Score

    Time frame: At approximately 3 months of age

    Scaled Score for Expressive Communication subscale of Bayley Scale for Infant Development that determines how well a child recognizes sounds and how much a child communicates using sounds, gestures, or words compared to a group of children within the same age range from across the United States. Subscale consists of 48 items. Child'e scaled score is calculated from total raw scores.

    Scaled score range: 2 - 9 Lower scores indicate more developmental delay.

  12. Infant's Fine Motor Skills Scaled Score

    Time frame: Approximately 3 months of age

    Fine motor skills subscale score from Bayley Scale for Infant Development. Determines how well a child recognizes sounds and how much a child can use his or her hands and fingers to do things compared to a group of children within the same age range from across the United States. Subscale consists of 66 items. Child's scaled score is calculated from total raw scores.

    Scaled score range: 1 - 8 Lower scores indicate more developmental delay.

  13. Infant's Gross Motor Skills Scaled Score

    Time frame: Approximately 3 months of age

    Infants Gross Motor skills subscale score from Bayley Scale for Infant Development. Determines how well a child well your child can move his or her body compared to a group of children within the same age range from across the United States. Subscale consists of 72 items. Child's scaled score is calculated from total raw scores.

    Scaled score range: 1 - 6 'Lower scores indicate more developmental delay.

Sponsors and collaborators

Lead sponsor

University of Chicago

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Registry information

Official study title

Impact of Omega-3 Intake During Pregnancy on Maternal Stress and Infant Outcome

Acronym: NAPS

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
Jul 8, 2010
Registry last updated
May 30, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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