Improving Maternal and Child Health Through Prenatal Fatty Acid Supplementation: A Randomized Controlled Study in African American Women Living in Low-income Urban Environments
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 入组人数
- 168
- 试验地点
- 2
- 主要终点
- Average Change in Perceived Stress Scale (PSS) Score From Visit 1 to Visit 4
研究概览
简要总结
The purpose of the study is to test whether nutritional supplementation during pregnancy is associated with 1) improved maternal health during pregnancy; 2) improved infant birth and neurodevelopmental outcomes, and 3) whether the association between nutritional supplementation during pregnancy and infant outcomes is partially mediated by reductions in maternal perceived stress and stress reactivity during pregnancy.
详细描述
Low-income pregnant women 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 the infant's capacity for emotion and behavioral regulation. This program of research is 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.
One hundred sixty-two pregnant women will be randomly assigned to receive 450 mg/daily of DHA or placebo beginning at 9-12 weeks of gestation through the end of pregnancy. Perceived stress, stressful life events, anxiety, and depression, inflammatory markers, DHA levels and response to a laboratory stressor will be assessed at baseline and at 24, 30, and 36 weeks of pregnancy. Neonatal outcomes (e.g., gestational age, birth weight, delivery complications) will be collected from medical records, and infant neurodevelopmental outcomes and stress reactivity will be assessed at 1, 4 and 9 months of age. Coded data will be analyzed by the Investigators at University of Chicago and University of Pittsburgh
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 34 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age between 18 and 34
- •Household recipient 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
- •Reports of known medial complications
- •Regular use of steroid medications, alcohol, cigarettes, or illegal substances (by maternal report)
- •Use of blood thinners or anti-coagulants
- •Use of psychotropic medications
- •Allergy to iodine and/or soy
研究组 & 干预措施
Oral supplement for pregnant women
450 mg/daily of DHA beginning at 10-16 weeks of gestation through the end of pregnancy
干预措施: DHA (Dietary Supplement)
Sugar pill
450 mg/daily of sugar pill beginning at 10-16 weeks of gestation through the end of pregnancy
干预措施: Sugar pill (Dietary Supplement)
结局指标
主要结局
Average Change in Perceived Stress Scale (PSS) Score From Visit 1 to Visit 4
时间窗: 16 months
Will be assessed at baseline and at 24, 30, and 36 weeks of pregnancy, and at 1, 4 and 9 months after giving birth. The Perceived Stress Scale score is obtained by summing the points awarded to the 10 items and it ranges from 0 to 40 where: 0-13 - Low stress 14-26 - Moderate stress 27-40 - High perceived stress
Average Change in Perceived Stress Scale (PSS) Score From Visit 1 to Visit 3
时间窗: 12 months
Will be assessed at baseline and at 24, 30, and 36 weeks of pregnancy, and at 1, 4 and 9 months after giving birth. The Perceived Stress Scale score is obtained by summing the points awarded to the 10 items and it ranges from 0 to 40 where: 0-13 - Low stress 14-26 - Moderate stress 27-40 - High perceived stress
次要结局
未报告次要终点
