Zn & Maternal-Infant Brain Function in S. Ethiopia: Randomized Controlled Trials

描述（由申请人提供）：本研究项目的总体目标是确定预防/治疗食物不安全高危人群营养不良对母婴大脑功能和发育的益处。本建议的具体目的是确定母婴锌（Zn）补充对母婴认知，气质和结合以及产前和产后大脑发育的影响。该提案包括进一步开发德布大学的研究资源。研究设计是一项随机对照试验（RCT），从妊娠中期早期到哺乳期9个月，对母亲补充3种不同剂量（0、12.5和25mg锌/天）的锌，并在此基础上，对6-9个月大的婴儿给予低剂量（0或3mg锌/天）的锌。这项研究将包括埃塞俄比亚南部五个相邻的农村Sidama社区的900名妇女及其后代。所有母亲每天都将获得多种维生素和能量蛋白质的补充。在基线、妊娠24 - 2周和34 - 2周以及哺乳期6 - 9月，采用Raven’s Colored Progressive Matrices和Kaufman-ABC在社区环境中对产妇的认知能力进行纵向评估。采用爱丁堡产后抑郁量表评估产后抑郁，采用护理儿童评估-喂养和教学量表（NCAST）评估母婴互动。在6岁（补充前）和9个月时，婴儿神经认知发展将通过新奇偏好来评估；气质采用实验室气质评估电池加贝利行为记录法；用贝利PDI评估运动功能。产后3天测量婴儿头围、体重和身长，然后每月测量一次。次要结局指标是：传染病发病率；产前和产后生长；母体血浆和母乳中锌的浓度及锌的吸收量。将使用一系列统计分析来检验第一个RCT（3组的单向设计）和第二个RCT （2 × 3的阶乘）的效果，p=0.05为双侧显著性。提高对锌的作用的理解对于全面了解营养不良对母婴脑功能和发育的影响至关重要，从而制定最佳的公共卫生战略，以预防与营养有关的脑功能紊乱。

DESCRIPTION (provided by applicant): The broad objective of this research program is to determine the benefits for maternal-young child brain function and development that can be achieved by preventing/treating malnutrition in a population at high risk from food insecurity. The specific aims of this proposal are to determine the effects of maternal and infant zinc (Zn) supplementation on: maternal-infant cognition, temperament and bonding and on pre-and post-natal brain growth. The proposal includes further development of research resources at Debub University. The research design is a randomized controlled trial (RCT) of 3 different doses (0,12.5 and 25mg Zn/d) of maternal Zn supplementation from early 2nd trimester of pregnancy until 9 months lactation and, nested within this, a second RCT of a low dose of Zn (0 or 3 mg Zn/d) administered to their infants from age 6-9 months. The study will include 900 women and their offspring in five adjacent rural Sidama communities in southern Ethiopia. All mothers will receive a daily multivitamin and energy-protein supplement. Maternal cognition will be assessed longitudinally in the community setting at baseline, 24¿2 and 34¿2 wks gestation and 6 and 9 mo lactation by Raven's Colored Progressive Matrices and Kaufman-ABC. Post-partum depression will be assessed by the Edinburgh Post-Partum Depression Scale and maternal-infant interaction by the Nursing Child-Assessment-Feeding and Teaching Scales (NCAST). At age 6 (prior to supplementation) and 9 mo, infant neurocognitive development will be assessed by Novelty Preference; temperament by Laboratory Temperament Assessment Battery plus Bayley Behavior Record; motor function will be assessed by Bayley PDI. Infant head circumference, weight and length will be measured 3 days post- delivery and then monthly. Secondary outcome measures are: incidence of infectious disease morbidity; pre- and post-natal growth; Zn concentrations in maternal plasma and breast milk and the quantity of Zn absorbed. A range of statistical analyses will be used to examine the effects of the 1st RCT (one-way design with 3 groups) and the 2nd RCT (2x3 factorial) with two-sided significance at p=0.05. Improved understanding of the role of Zn is essential to overall understanding of the impact of malnutrition on maternal-infant brain function and development and, thence, to developing optimal public health strategies for the prevention of nutrition-related disorders of brain function.