Эта страница была переведена автоматически, точность перевода не гарантируется. Пожалуйста, обратитесь к английской версии для исходного текста.

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

30 апреля 2018 г. обновлено: University of Chicago

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.

Обзор исследования

Статус

Завершенный

Условия

Вмешательство/лечение

Подробное описание

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.

Тип исследования

Интервенционный

Регистрация (Действительный)

64

Фаза

  • Непригодный

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Места учебы

  • Соединенные Штаты
    • Illinois
      • Chicago, Illinois, Соединенные Штаты, 60637
        • University of Chicago
    • Pennsylvania
      • Pittsburgh, Pennsylvania, Соединенные Штаты, 15213
        • University of Pittsburgh Medical Center

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

От 20 лет до 34 года (Взрослый)

Принимает здоровых добровольцев

Да

Полы, имеющие право на обучение

Женский

Описание

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.

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

  • Основная цель: Фундаментальная наука
  • Распределение: Рандомизированный
  • Интервенционная модель: Параллельное назначение
  • Маскировка: Тройной

Оружие и интервенции

Группа участников / Армия
Вмешательство/лечение
Экспериментальный: DHA supplementation
Диетическая добавка: Docosahexanoic Acid
450 mg DHA daily beginning at 16-21 weeks gestation and continuing up to time of delivery
Другие имена:
  • Nordic Naturals ProDHA
Плацебо Компаратор: Soybean Oil
Другой: Placebo
soybean oils with strawberry flavoring

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Maternal Cortisol Levels
Временное ограничение: Baseline (pre-stressor)
Maternal stress regulation at 30 weeks gestation
Baseline (pre-stressor)
Maternal Cortisol Levels
Временное ограничение: 20 minutes post-stressor
Maternal stress regulation at 30 weeks gestation
20 minutes post-stressor
Maternal Cortisol Levels
Временное ограничение: 45 minutes post stressor
Maternal stress regulation at 30 weeks gestation
45 minutes post stressor
Infant Cortisol Levels
Временное ограничение: 4 months post-partum
Infant cortisol response to the Still-Face paradigm before stressor
4 months post-partum
Infant Cortisol Levels
Временное ограничение: 4 months post-partum
Infant cortisol response to the Still-Face paradigm 20 minutes post-stressor
4 months post-partum
Infant Cortisol Levels
Временное ограничение: 4 months post-partum
Infant cortisol response to the Still-Face paradigm 45 mins post-stressor
4 months post-partum

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Maternal Depression Symptoms
Временное ограничение: 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.
16-21 weeks gestation
Maternal Depression Symptoms
Временное ограничение: 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.
24 weeks
Maternal Depression Symptoms
Временное ограничение: 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.
30 weeks gestation
Maternal Perceived Stress Scale (PSS) Score
Временное ограничение: 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
Baseline: 16 - 21 weeks
Maternal Perceived Stress Scale Score
Временное ограничение: 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
24 weeks gestation
Maternal Perceived Stress Scale Score
Временное ограничение: 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
30 weeks gestation
Infant Birth Weight
Временное ограничение: Time of birth, total sample range: 27.60 to 41.60 weeks gestation
Weight of infant
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
Временное ограничение: 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
Time of birth, total sample range: 27.60 to 41.60 weeks gestation
Gestational Age (GA)
Временное ограничение: 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
Time of birth, total sample range: 27.60 to 41.60 weeks gestation
Infant's Receptive Communication Scaled Score
Временное ограничение: 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.
3 months old
Infant's Expressive Communication Scaled Score
Временное ограничение: 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.
At approximately 3 months of age
Infant's Fine Motor Skills Scaled Score
Временное ограничение: 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.
Approximately 3 months of age
Infant's Gross Motor Skills Scaled Score
Временное ограничение: 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.
Approximately 3 months of age

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

University of Chicago

Соавторы

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

Публикации и полезные ссылки

Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.

Общие публикации

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования

1 декабря 2009 г.

Первичное завершение (Действительный)

1 июня 2013 г.

Завершение исследования (Действительный)

1 июня 2013 г.

Даты регистрации исследования

Первый отправленный

28 июня 2010 г.

Впервые представлено, что соответствует критериям контроля качества

7 июля 2010 г.

Первый опубликованный (Оценивать)

8 июля 2010 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

30 мая 2018 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

30 апреля 2018 г.

Последняя проверка

1 апреля 2018 г.

Дополнительная информация

Термины, связанные с этим исследованием

Другие идентификационные номера исследования

  • 09-190A
  • R21HD058269 (Грант/контракт NIH США)

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

Подписаться