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 轻度至中度碘缺乏症（ID）在全世界范围内仍然普遍存在于孕妇和哺乳期妇女中 他们的饮食需求比普通人群高。碘是合成 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。孕期补碘对重度碘缺乏症的益处 在童年时期，然而，在轻度- 至中度ID和哺乳期仍不清楚。此外，迄今为止，很少有试验研究了 妊娠期或哺乳期补碘对碘特异性神经功能的影响。关于NICHD NOSI（NOT-HD-19-039），我们提供了一个独特的机会，以建立在一个正在进行的随机对照试验 (RCT)为了解决碘缺乏对人群中胎儿和婴儿神经发育的影响， 埃塞俄比亚农村的轻度到中度碘缺乏症。在受资助的父母怀孕试验中， 孕妇随机接受一揽子强化营养支持（包括每月供应的 碘盐）和/或感染控制包。受资助的父母怀孕试验将决定效果 对婴儿出生结果的干预。在这个奖项的支持下，我们建议增加一个哺乳期 采用有效2x2析因设计进行干预，并在分娩后随机分配妇女接受a） 强化碘盐干预措施，包括每月供应高质量、适当加碘的 盐和关于适当储存和使用的咨询，或B）标准护理，直到术后6个月。 分娩的时候。我们的总体目标是检查妊娠期和哺乳期碘对婴儿脑功能的影响， 以及母亲和婴儿的碘状况和甲状腺功能。该项目的具体目标是：（1） 确定妊娠期和哺乳期强化盐干预对婴儿视觉诱发电位的影响， 6个月时的电位（主要结局）以及视觉注意力、运动功能和头围 （2）确定碘盐干预对母亲母乳碘浓度的影响， 以及婴儿碘状态和甲状腺功能;（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战略， 碘输送。据我们所知，这项试验将是第一个严格的，充分把握度的高保真随机对照试验。 在轻度-中度碘环境中，沿着妊娠期和哺乳期连续提供碘盐 缺陷这些发现将提高我们对碘在早期人类大脑中作用的理解 制定有效的有针对性的干预战略，以改善碘营养状况， 世界各地儿童的神经发育结果。