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.
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.
