DHA Supplementation and Pregnancy Outcome

DHA 补充和怀孕结果

• 批准号: 7218658
• 负责人: SUSAN E CARLSON
• 金额: $ 52.2万
• 依托单位: UNIVERSITY OF KANSAS MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-04-04 至 2011-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7218658
• 关键词: Address; Adverse event; Affect; Age-Months; Attention; Birth; Birth Weight; Brain; Cell membrane; Childhood; Clinical; Clinical Trials; Cognitive; Competence; Condition; Conduct Clinical Trials; Corn Oil; Daily; Data; Development; Dietary intake; Docosahexaenoic Acids; Dose; Double-Blind Method; Erythrocytes; Event; Family; Fetal Growth; Frequencies; Gestational Diabetes; Glycine max; Health; Human; Incidence; Individual Differences; Infant; Intake; Intervention; Length; Life; Longevity; Low Birth Weight Infant; Measures; Mothers; Oils; Omega-3 Fatty Acids; Outcome; Patient currently pregnant; Phase; Phase III Clinical Trials; Phospholipids; Placebo Control; Placebos; Population; Population Study; Pre-Eclampsia; Pregnancy; Pregnancy Complications; Pregnancy Outcome; Pregnancy Trimesters; Pregnant Women; Premature Birth; Premature Infant; Randomized Clinical Trials; Research; Research Personnel; Retina; Risk; Role; Safety; Sampling; Soybeans; Supplementation; Testing; Third Pregnancy Trimester; Visual; Visual Acuity; Visual evoked cortical potential; Woman; Work; base; capsule; cognitive function; day; design; dosage; early childhood; egg; fetal; infancy; member; postnatal; prenatal; respiratory; surfactant

DESCRIPTION (provided by applicant): Docosahexaenoic acid (DHA) is a member of the omega-3 fatty acid family; it is found in all cell membranes, and is accumulated in especially large quantities in the retina and brain. Over the past decades, evidence has accumulated in support of the hypothesis that DHA may have an important role in pregnancy health and outcome, as well as in the postnatal development of perceptual and cognitive function in infancy. However, prior work on this topic has focused on postnatal supplementation and the amelioration of risk in premature infants; this is in contrast to evidence indicating that DHA is accumulated in the fetal brain during gestation, probably through maternal dietary intake. The current proposal is therefore based on the possibility that prenatal supplementation may be an especially efficacious means of affecting positive pregnancy and postnatal outcomes. An earlier clinical trial conducted by our research team provided a relatively low level of DHA supplementation (approximately 100 mg/day) during the last trimester of pregnancy. This supplementation produced an increase of 6 days in the duration of gestation. In addition, higher maternal RBC DHA at delivery in a subset of this population was related to infant cognitive outcomes (more mature infant attention and lower infant distractibility through 18 months of age). In the current application, we propose a Phase III Clinical Trial (randomized, double blind, placebo-controlled) with a larger supplement of DHA (600 mg/day vs 100 mg/day) and longer duration of supplementation (2 vs 1 trimester of pregnancy). This increased dosage and period of exposure is designed to increase gestation duration and intrauterine growth in the same population studied in the previous clinical trial. Reviewers of the initial submission felt the value of the study would be increased by infant followup. An extensive postnatal followup was included in the revision, designed to determine the effect of experimentally increasing maternal DHA intake on visual and cognitive outcomes in infancy and early childhood. Reviewers indicated approval of the added postnatal followup, however, they raised several new questions about compliance with capsule intake and possibly high attrition from the postnatal followup portion of the study and requested operational definitions of some measures. These have been addressed here in detail in the Introduction and body of the proposal.

描述（由申请人提供）：二十二碳六烯酸（DHA）是omega-3脂肪酸家族的成员；它存在于所有细胞膜中，在视网膜和大脑中积聚的量尤其大。在过去的几十年里，越来越多的证据支持DHA可能在怀孕健康和结局以及婴儿出生后的感知和认知功能发展中发挥重要作用的假设。然而，关于这一主题的先前工作主要集中在产后补充和改善早产儿的风险；这与有证据表明DHA在怀孕期间可能通过母亲的饮食摄入在胎儿大脑中积累形成对比。因此，目前的建议是基于产前补充可能是影响妊娠和产后结果的特别有效的手段的可能性。我们的研究小组进行的早期临床试验提供了一个相对较低水平的DHA补充（约100毫克/天）在怀孕的最后三个月。这种补充使妊娠期增加了6天。此外，在这一人群的一个子集中，分娩时较高的母亲红细胞DHA与婴儿的认知结果有关（到18个月大时，婴儿的注意力更成熟，注意力更分散）。在目前的申请中，我们建议进行III期临床试验（随机、双盲、安慰剂对照），增加DHA的补充量（600毫克/天vs 100毫克/天），延长补充时间（2个月vs 1个月）。增加剂量和暴露时间的目的是增加先前临床试验中研究的同一人群的妊娠持续时间和宫内生长。最初提交的审稿人认为，通过对婴儿进行随访，这项研究的价值将会增加。修订中包括了一项广泛的产后随访，旨在确定实验性地增加母亲DHA摄入量对婴儿和幼儿期视觉和认知结果的影响。审稿人表示同意增加产后随访，然而，他们提出了一些关于胶囊摄入依从性的新问题，以及研究中产后随访部分可能出现的高损耗，并要求对一些措施进行操作定义。这些问题已在本建议的导言和正文中详细讨论。