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

妊娠期和哺乳期碘盐对埃塞俄比亚农村婴儿神经发育的影响

• 批准号: 10345892
• 负责人: Anne Shee CC Lee
• 金额: $ 69.84万
• 依托单位: BRIGHAM AND WOMEN'S HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-07-01 至 2027-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10345892
• 关键词: Address; Age-Months; Alberta province; Award; Behavioral; Birth; Blood; Brain; Child; Childhood; Counseling; Development; Dietary intake; Electroencephalogram; Electrophysiology (science); Ethiopia; Feeding Patterns; Ferritin; Food; Foundations; Funding; General Population; Goals; Grant; Head circumference; Human; Human Milk; Infant; Infection; Infection Control; Infectious Pregnancy Complications; Intervention; Iodine; Iron; Knowledge; Lactation; Language; Life; Measures; Memory; Mothers; Motor; National Institute of Child Health and Human Development; Neurocognitive Deficit; Neurodevelopmental Impairment; Neurophysiology - biologic function; Outcome; Parents; Pattern; Play; Population; Postpartum Period; Pregnancy; Pregnant Women; Prenatal Nutrition; Randomized; Randomized Controlled Trials; Research; Role; Rural; Selenium; Sodium Chloride; Spottings; Supplementation; TFRC gene; Testing; Third Pregnancy Trimester; Thyroglobulin; Thyroid Function Tests; Thyroid Hormones; Thyrotropin; Thyroxine; Urine; Variant; Visual attention; Visual evoked cortical potential; Woman; adverse birth outcomes; antenatal; arm; behavior measurement; cost efficient; design; dietary requirement; early pregnancy; fetal; group intervention; improved; intervention delivery; intervention effect; iodine deficiency syndrome; iodized salt; multimodality; myelination; neurodevelopment; novel; nutrition; pregnant; primary outcome; relating to nervous system; response; standard care

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.

项目摘要 在怀孕和哺乳期妇女中，温和到中度碘缺陷（ID）在全球范围内仍然广泛 比一般人群更高的饮食要求。碘是必需的 甲状腺激素，这对于人类脑发育至关重要，尤其是视觉注意力，精细电机 发展，语言和记忆。怀孕期间对严重ID补充碘的好处 并在童年时期建立了。但是，在有轻度的环境中补充碘的影响 待机ID和泌乳期间尚不清楚。此外，迄今为止很少有试验检查效果 在妊娠或泌乳特异性神经功能上补充碘的。回应NICHD NOSI（NOT-HD-19-039），我们提供了一个独特的机会，以构建正在进行的随机对照试验 （RCT）解决碘缺乏对人群中胎儿和婴儿神经发育的后果 埃塞俄比亚农村地区的轻度至中度碘缺陷。在资助的父母怀孕试验中，妇女早期 怀孕是随机的 碘化盐）和/或一包感染控制。资助的父母怀孕试验将确定效果 关于婴儿出生结果的干预措施。在该奖项的支持下，我们建议增加哺乳 使用高效的2x2阶乘设计的干预措施并在分娩后随机对妇女进行随机分组，以接收a） 密集的碘化盐干预，包括每月提供高质量的供应，充分碘化 盐和有关适当存储和使用的咨询，或b）标准护理，直到6个月后 - 零件。我们的总体目标是检查碘在妊娠和泌乳对婴儿脑功能的影响， 以及母体和婴儿碘状况和甲状腺功能。该项目的具体目的是：（1） 确定强化盐干预对妊娠和泌乳对婴儿视觉诱发的影响 电位（主要结果）以及6个月时视觉注意力，运动功能和头圆周 年龄； （2）确定碘化盐干预对母乳碘浓度的影响，如 以及婴儿碘状态和甲状腺功能； （3）检查铁与碘之间的相互作用 甲状腺功能在妊娠和哺乳期。在全球范围内，盐碘化是主要的干预策略 碘交付。据我们所知，该试验将是第一个严格的高保真性RCT 在温和碘的情况下，沿着怀孕和哺乳的连续体提供的碘盐提供 不足。这些发现将提高我们对碘在早期人大脑中的作用的理解 开发以制定有效的有针对性的干预策略，以提高碘状况和 全球儿童的神经发育结果。