Effect of iodized salt in pregnancy and lactation on infant neurodevelopment in rural Ethiopia

项目总结 轻度至中度缺碘(ID)在全世界孕妇和哺乳期妇女中仍然普遍存在 他们对饮食的要求比一般人高。碘是合成的必需品。 甲状腺激素，这是人类大脑发育所必需的，特别是视觉注意力，精细运动 发展、语言和记忆。妊娠期补碘对重度缺碘的益处 在童年时期就已经建立起来了。然而，在轻度-肥胖人群中补充碘的效果。 到中度缺铁和哺乳期仍不清楚。此外，到目前为止，很少有试验检验这种影响。 孕期或哺乳期补碘对碘专一性神经功能的影响。对NICHD的回应 NOSI(非HD-19-039)，我们提供了一个独特的机会来建立正在进行的随机对照试验 (RCT)解决缺碘对人群中胎儿和婴儿神经发育的影响 埃塞俄比亚农村地区存在轻度至中度缺碘。在资助的父母怀孕试验中，妇女在早期 孕妇随机接受一揽子强化营养支持(包括每月供应 加碘食盐)和/或一揽子感染控制措施。资助的双亲怀孕试验将决定其效果 关于婴儿出生结局的干预措施。在这个奖项的支持下，我们建议增加一个哺乳期 干预采用有效的2x2析因设计，并在分娩后随机选择妇女接受a)和 强化加碘食盐干预，包括每月供应高质量、充分加碘的食盐 盐和关于适当储存和使用的咨询，或b)标准护理，直到6个月后- 分娩期。我们的总体目标是研究孕期和哺乳期碘对婴儿大脑功能的影响， 以及母婴的碘状况和甲状腺功能。本项目的具体目标是：(1) 确定孕期和哺乳期强化盐干预对婴儿视觉诱发的影响 潜伏期(主要结果)，以及6个月时的视觉注意力、运动功能和头围 (2)确定加碘盐干预对母亲母乳碘浓度的影响，如 以及婴儿的碘状况和甲状腺功能；以及(3)检查铁和碘在 妊娠和哺乳期的甲状腺功能。在全球范围内，食盐加碘是防治艾滋病的主要干预战略 碘递送。据我们所知，这项试验将是第一个严格的、足够强大的高保真RCT 在轻度-中度碘环境中沿妊娠和哺乳期连续供应碘盐 缺乏症。这些发现将提高我们对碘在早期人类大脑中的作用的理解 制定有效的针对性干预战略，以改善碘状况和 全球儿童的神经发育结果。

PROJECT SUMMARY Mild-to-moderate iodine deficiency (ID) remains widespread worldwide among pregnant and lactating women who have higher dietary requirements than the general population. Iodine is required for the synthesis of thyroid hormone, which is essential for human brain development, particularly visual attention, fine motor development, language and memory. The benefits of iodine supplementation for severe ID during pregnancy and in childhood have been established. However, the effects of iodine supplementation in settings with mild- to-moderate ID and during lactation remain unclear. Furthermore, few trials to date have examined the effects of iodine supplementation in pregnancy or lactation on iodine-specific neural functions. In response to NICHD NOSI (NOT-HD-19-039), we present a unique opportunity to build upon an ongoing, randomized controlled trial (RCT) to address the consequences of iodine deficiency on fetal and infant neurodevelopment in a population of mild-to-moderate iodine deficiency in rural Ethiopia. In the funded parent pregnancy trial, women in early pregnancy are randomized to receive a package of strengthened nutrition support (including monthly supply of iodized salt) and/or a package of infection control. The funded parent pregnancy trial will determine the effect of the interventions on infant birth outcomes. With support from this award, we propose to add a lactation intervention utilizing an efficient 2x2 factorial design and randomize women after delivery to receive a) an intensive iodized salt intervention, including provision of a monthly supply of high-quality, adequately iodized salt and counseling regarding appropriate storage and use, or b) standard care, until 6 months post- partum. Our overall goal is to examine the effects of iodine in pregnancy and lactation on infant brain function, as well as maternal and infant iodine status and thyroid function. The specific aims of this project are to: (1) determine the effects of an intensive salt intervention in pregnancy and lactation on infant visual evoked potentials (primary outcome), as well as visual attention, motor function, and head circumference at 6 months of age; (2) determine the effect of the iodized salt intervention on maternal breast milk iodine concentration, as well as infant iodine status and thyroid function; and (3) examine interactions between iron and iodine on thyroid function in pregnancy and lactation. Globally, salt iodization is the primary intervention strategy for iodine delivery. To our knowledge, this trial will be the first rigorous, adequately powered RCT of high-fidelity iodized salt provision along the continuum of pregnancy and lactation in a setting of mild-moderate iodine deficiency. These discoveries will improve our understanding of the role of iodine in early human brain development in order to develop effective targeted intervention strategies to improve iodine status and neurodevelopmental outcomes in children worldwide.