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

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ClinicalTrials.gov Identifier: NCT01158976
Recruitment Status : Completed
First Posted : July 8, 2010
Results First Posted : May 30, 2018
Last Update Posted : May 30, 2018
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
University of Chicago

June 28, 2010
July 8, 2010
May 2, 2017
May 30, 2018
May 30, 2018
December 2009
June 2013   (Final data collection date for primary outcome measure)
  • Maternal Cortisol Levels [ Time Frame: Baseline (pre-stressor) ]
    Maternal stress regulation at 30 weeks gestation
  • Maternal Cortisol Levels [ Time Frame: 20 minutes post-stressor ]
    Maternal stress regulation at 30 weeks gestation
  • Maternal Cortisol Levels [ Time Frame: 45 minutes post stressor ]
    Maternal stress regulation at 30 weeks gestation
  • Infant Cortisol Levels [ Time Frame: 4 months post-partum ]
    Infant cortisol response to the Still-Face paradigm before stressor
  • Infant Cortisol Levels [ Time Frame: 4 months post-partum ]
    Infant cortisol response to the Still-Face paradigm 20 minutes post-stressor
  • Infant Cortisol Levels [ Time Frame: 4 months post-partum ]
    Infant cortisol response to the Still-Face paradigm 45 mins post-stressor
  • Maternal cortisol response to a laboratory stressor [ Time Frame: Baseline: 17-20 weeks gestation ]
    Maternal stress regulation
  • Maternal cortisol response to a laboratory stressor [ Time Frame: 24 weeks gestation ]
    Maternal stress regulation
  • Maternal cortisol response to a laboratory stressor [ Time Frame: 30 weeks gestation ]
    Maternal stress regulation
  • DHA Levels [ Time Frame: 36 weeks ]
    Amount of DHA in blood
  • Infant cortisol response to the Still-Face paradigm [ Time Frame: 4 months post-partum ]
    Infant stress regulation
Complete list of historical versions of study NCT01158976 on ClinicalTrials.gov Archive Site
  • 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.

  • 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.

  • 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.

  • 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
  • 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
  • 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
  • Infant Birth Weight [ Time Frame: Time of birth, total sample range: 27.60 to 41.60 weeks gestation ]
    Weight of infant
  • 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
  • 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
  • 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.

  • 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.

  • 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.

  • 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.

  • Maternal anxiety and depression [ Time Frame: Baseline: 17-21 weeks gestation ]
    depression and anxiety symptoms
  • Maternal anxiety and depression [ Time Frame: 24 weeks ]
    depression and anxiety symptoms
  • Maternal anxiety and depression [ Time Frame: 30 weeks gestation ]
    anxiety and depression symptoms
  • Maternal anxiety and depression [ Time Frame: 36 weeks ]
    anxiety and depression symptoms
Not Provided
Not Provided
 
Effect of Omega-3 Supplementation During Pregnancy on Regulation of Stress
Impact of Omega-3 Intake During Pregnancy on Maternal Stress and Infant Outcome
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.
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.
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Healthy Pregnant Women
  • 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
  • Other: Placebo
    soybean oils with strawberry flavoring
  • Experimental: DHA supplementation
    Intervention: Dietary Supplement: Docosahexanoic Acid
  • Placebo Comparator: Soybean Oil
    Intervention: Other: Placebo
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):1080-7. doi: 10.1097/AOG.0000000000000559.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
64
66
June 2013
June 2013   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: Female
20 Years to 34 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01158976
09-190A
R21HD058269 ( U.S. NIH Grant/Contract )
Yes
Not Provided
Not Provided
University of Chicago
University of Chicago
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Not Provided
University of Chicago
April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP