Carotenoid Supplementation During Pregnancy: Ocular and Systemic Effects

项目摘要/摘要 产前补充维生素和微量营养素是全世界孕妇的标准护理； 然而，除了少数成分外，大多数产前补充指南还没有 得到大量前瞻性临床研究的支持。最近，添加叶黄素和黄体素的产前补充剂 玉米黄质已经进入美国市场，声称其意图是增强婴儿的视觉和神经 发展。尽管从未进行过临床试验来支持这一论点，但从生理上讲 从新生儿的角度来看是合理的，因为这些饮食中的类胡萝卜素选择性地集中在 人的眼睛和神经组织在子宫中，特别是在怀孕的第三个月期间，有 越来越多的证据表明，叶黄素和玉米黄质不仅可以预防老年人的黄斑变性，而且 它们还可以增强对比敏感度，减少眩光障碍，并增加视力和 认知贯穿一生。黄斑类胡萝卜素在出生时就可以检测到，而且水平随着年龄的增长而增加。 在他们可以对视觉功能和中心凹发育做出贡献的时候。从母亲的角度来看， 怀孕的最后三个月是她必须将她的一些类胡萝卜素储备转移到 发育中的婴儿，可能会使她面临全身和眼组织衰竭的风险。 由于对母亲和他们的婴儿的长期健康的重要性，随机、对照的 建议使用最先进的量化评估工具进行研究；然而，在开始 潜在的非常大的多中心临床试验，适宜进行较小规模的先导研究来探索 研究招聘和留用的可行性，并开发信息，以便为今后的研究提供适当的支持。 目前，所有关于类胡萝卜素在产前健康中的作用的现有数据都是横断面的或观察性的， 拟议的研究旨在检验以下假设：[a]怀孕的第三个三个月确实是一个 母体和眼部类胡萝卜素耗竭的时期；[b]商业化的产前补充 可获得的含有叶黄素和玉米黄质的产前补充剂将抵消这种减少； 与产前补充类胡萝卜素相关的母亲类胡萝卜素状况增强将增加 新生儿全身类胡萝卜素水平和黄斑色素。 这项R21研究将提供必要的初步数据，为未来更大规模的前景提供设计和动力 进一步优化配方以确定产前和出生后类胡萝卜素的临床试验 补充剂可以对母亲的视觉功能和婴儿的视觉和认知产生有益的影响 正常妊娠和高危妊娠的发育。研究结果还可能为以下方面提供循证支持 指导关于提高母婴类胡萝卜素的产前营养建议的决策 特别是在世界上有营养不良风险的地区。

Project Summary/Abstract Prenatal vitamin and micronutrient supplementation is standard-of-care for pregnant women worldwide; however, with the exception of a few ingredients, most prenatal supplementation guidelines are not yet supported by substantial prospective clinical research. Recently, prenatal supplements with added lutein and zeaxanthin have entered the American market with the stated intentions of enhancing infant visual and neural development. Although clinical trials were never performed to support this contention, it is physiologically plausible from the neonate's perspective because these dietary carotenoids are selectively concentrated in human ocular and neural tissue in utero, especially during the third trimester of pregnancy, and there is increasing evidence that lutein and zeaxanthin not only protect against macular degeneration in the elderly, but they may also function to enhance contrast sensitivity, decrease glare disability, and increase visual acuity and cognition throughout life. The macular carotenoid pigment is detectable at birth, and levels increase with age at a time when they can contribute to visual function and foveal development. From the mother's perspective, the last trimester of pregnancy is a time when she must transfer some of her carotenoid stores to the developing infant, potentially putting her at risk for depletion systemically and in her ocular tissues. Because of the importance to the long-term health of both mothers and their infants, a randomized, controlled study using state-of-the-art quantitative assessment tools is indicated; however, before embarking on a potentially very large multi-center clinical trial, it is appropriate to conduct a smaller-scale pilot study to explore the feasibility of recruitment and retention and to develop the information to properly power future studies. Currently, all available data on the role of carotenoids in prenatal health are cross-sectional or observational, The proposed study is designed to test the hypotheses that: [a] the third trimester of pregnancy is indeed a period of maternal systemic and ocular carotenoid depletion; [b] prenatal supplementation with commercially available prenatal supplements containing lutein and zeaxanthin will counteract this reduction; [c] the enhanced maternal carotenoid status associated with prenatal carotenoid supplementation will increase systemic carotenoid levels and macular pigment in their newborn infants. This R21 study will provide necessary preliminary data to design and power future, larger-scale prospective clinical trials with further optimized formulations to determine whether prenatal and postnatal carotenoid supplementation can have beneficial effects on maternal visual function and on infant visual and cognitive development in normal and high-risk pregnancies. The results may also provide evidence-based support to guide policy decisions about prenatal nutritional recommendations to enhance maternal and infant carotenoid status, especially in regions of the world at risk for malnutrition.