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.

项目概要 轻度至中度碘缺乏症 (ID) 在全世界孕妇和哺乳期妇女中仍然普遍存在 饮食要求高于一般人群的人。合成需要碘 甲状腺激素，对人类大脑发育至关重要，特别是视觉注意力、精细运动 发育、语言和记忆。怀孕期间补充碘对严重ID的好处 并在童年时期就已确立。然而，在轻度的环境中补充碘的效果 至中度 ID 和哺乳期间仍不清楚。此外，迄今为止，很少有试验检验其影响 妊娠期或哺乳期补充碘对碘特异性神经功能的影响。回应 NICHD NOSI (NOT-HD-19-039)，我们提供了一个独特的机会来构建正在进行的随机对照试验 （随机对照试验）解决碘缺乏对人群胎儿和婴儿神经发育的影响 埃塞俄比亚农村地区轻度至中度缺碘的情况。在资助的父母怀孕试验中，早期妇女 怀孕者被随机分配接受一揽子强化营养支持（包括每月供应 碘盐）和/或感染控制包。资助的父母怀孕试验将确定效果 对婴儿出生结局的干预措施。在该奖项的支持下，我们建议增加哺乳期 利用有效的 2x2 析因设计进行干预，并在分娩后对妇女进行随机分组，以接受 a) 强化碘盐干预，包括每月供应高质量、充分碘化的食盐 盐和有关适当储存和使用的咨询，或 b) 标准护理，直至使用后 6 个月 产妇。我们的总体目标是检查怀孕和哺乳期碘对婴儿大脑功能的影响， 以及母婴碘状况和甲状腺功能。该项目的具体目标是：（1） 确定怀孕和哺乳期强化盐干预对婴儿视觉诱发的影响 6 个月时的潜力（主要结果）以及视觉注意力、运动功能和头围 年龄； (2)确定加碘盐干预对母乳碘浓度的影响，为 以及婴儿的碘状况和甲状腺功能； (3) 检查铁和碘之间的相互作用 妊娠期和哺乳期的甲状腺功能。在全球范围内，食盐加碘是主要的干预策略 碘输送。据我们所知，这项试验将是第一个严格的、动力充足的高保真随机对照试验 在轻度至中度碘的环境下，在怀孕和哺乳期间提供碘盐 不足。这些发现将增进我们对碘在早期人类大脑中的作用的理解 制定有效的有针对性的干预策略，以改善碘状况和 全世界儿童的神经发育结果。