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临床试验/NCT01158976
NCT01158976已完成不适用

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

University of Chicago4 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2009年12月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
64
试验地点
4
主要终点
Maternal Cortisol Levels

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
20 Years 至 34 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

研究组 & 干预措施

Soybean Oil

Placebo Comparator

干预措施: Placebo (Other)

DHA supplementation

Experimental

干预措施: Docosahexanoic Acid (Dietary Supplement)

结局指标

主要结局

Maternal Cortisol Levels

时间窗: 45 minutes post stressor

Maternal stress regulation at 30 weeks gestation

Infant Cortisol Levels

时间窗: 4 months post-partum

Infant cortisol response to the Still-Face paradigm before stressor

次要结局

  • Infant Birth Weight(Time of birth, total sample range: 27.60 to 41.60 weeks gestation)
  • Infant's Expressive Communication Scaled Score(At approximately 3 months of age)
  • Maternal Depression Symptoms(30 weeks gestation)
  • Maternal Perceived Stress Scale (PSS) Score(Baseline: 16 - 21 weeks)
  • Maternal Perceived Stress Scale Score(30 weeks gestation)
  • Percentage of Infants Who Had a 1-minute Apgar Scores of 9(Time of birth, total sample range: 27.60 to 41.60 weeks gestation)
  • Infant's Receptive Communication Scaled Score(3 months old)
  • Gestational Age (GA)(Time of birth, total sample range: 27.60 to 41.60 weeks gestation)
  • Infant's Fine Motor Skills Scaled Score(Approximately 3 months of age)
  • Infant's Gross Motor Skills Scaled Score(Approximately 3 months of age)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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