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

描述(申请人提供)：这项研究计划的广泛目标是确定通过预防/治疗食品不安全高危人群中的营养不良可以实现的对母婴大脑功能和发育的好处。这项建议的具体目的是确定母婴补锌对母婴认知、性情和凝聚力的影响，以及对出生前和出生后大脑发育的影响。该提案包括进一步开发Debub大学的研究资源。研究设计是一项随机对照试验(RCT)，从怀孕早期到哺乳9个月，每天补充0、12.5和25 mg锌，并在此基础上，从6-9个月开始给婴儿补充低剂量锌(0或3 mg/d)。这项研究将包括埃塞俄比亚南部五个邻近的Sidama农村社区的900名妇女及其子女。所有母亲每天都将获得多种维生素和能量蛋白质补充剂。母体认知将在基线、妊娠24周和34周以及哺乳6个月和9个月时在社区环境中通过乌鸦有色渐进矩阵和考夫曼-ABC进行纵向评估。产后抑郁症将通过爱丁堡产后抑郁量表进行评估，母婴互动将通过护理儿童评估-喂养和教学量表(NCAST)进行评估。在6岁(补充前)和9个月时，婴儿的神经认知发育将通过新颖性偏好进行评估；气质将通过实验室气质评估组合加上贝利行为记录进行评估；运动功能将通过贝利PDI进行评估。婴儿头围、体重和身长将在产后3天测量，然后每月测量。次要观察指标是：传染病发病率；出生前和出生后生长；母体血浆和母乳中的锌浓度以及锌的摄入量。一系列的统计分析将被用来检验第一次随机对照试验(三组单向设计)和第二次随机对照试验(2x3因子)的效果，具有双侧显著性，p=0.05。更好地了解锌的作用，对于全面了解营养不良对母婴大脑功能和发育的影响，从而制定预防营养相关脑功能障碍的最佳公共卫生策略至关重要。

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.