A Trial of Zinc and Micronutrients in Tanzanian Children

描述(由申请人提供)：越来越多的证据支持单一和最近的多种微量营养素补充剂在降低易感人群的发病率和死亡率方面的有效性。我们在艾滋病毒阳性的坦桑尼亚妇女中进行的多种微量营养素补充试验显示，早产、胎儿丢失和低出生体重显著减少。此外，补充母亲所生婴儿的艾滋病毒传播率和发病率也有所降低。由于多种微量营养素缺乏症同时发生的可能性，以及营养补充剂之间可能存在的协同作用，我们的下一个优先事项是评估多种微量营养素补充剂在易感儿童中的疗效。在这项应用中，我们建议研究补充锌或多种微量营养素在降低坦桑尼亚2400名婴幼儿感染疾病和发育迟缓风险方面的效果。HIV阴性妇女所生的婴儿(n=2400)将被招募，并按析因设计随机分配到锌、微量营养素(维生素C、E、B1、B2、烟酸、B6、叶酸和B12)加锌、不含锌的微量营养素或每日服用安慰剂。儿童将在6周至18个月的每月门诊中接受跟踪，家访将在研究访问之间的中点进行。获得的数据将包括社会经济状况、人体测量数据(体重、身高、头围和手臂人体测量)、饮食摄入量(包括母乳喂养持续时间和频率)、血红蛋白、铁蛋白。以及疟疾的血液涂片。主要结果将是腹泻和呼吸道感染的发生率。次要结果将是体重和长度增加。一组儿童将接受血液中维生素A、E、锌和C反应蛋白浓度的测试，以及肠道通透性的测量。根据坦桑尼亚的护理标准，所有儿童将每6个月接受一次大剂量的定期维生素A治疗。坦桑尼亚研究人员和哈佛大学公共卫生学院之间的合作历史悠久，Duggan博士和Fawzi博士在各种发展中国家环境中进行合作研究的记录也很长。作为营养、儿科、流行病学和妇幼健康领域的专家，我们的团队致力于进一步评估微量营养素在改善儿童健康方面可能发挥的作用。

DESCRIPTION (provided by applicant): An increasing body of evidence supports the efficacy of single and, more recently, multiple micronutrient supplementation in reducing morbidity and mortality in susceptible populations. Our multiple micronutrient supplementation trial in HIV-positive Tanzanian women showed a significant reduction in pre-term birth, fetal loss, and low birth weight. In addition, reduced rates of HIV transmission and morbidity were seen in subsets of infants born to supplemented mothers. Because of the likelihood of multiple micronutrient deficiencies occurring simultaneously, and because of likely synergism among nutrient supplementation, our next priority is to evaluate the efficacy of multiple micronutrient supplementation in susceptible children. In this application, we propose to study the efficacy of zinc or multiple micronutrient supplementation in reducing the risk of infectious diseases and growth faltering among 2400 infants and young children in Tanzania. Infants (n=2400) born to HIV-negative women will be recruited and randomly assigned in a factorial design to either zinc, micronutrients (vitamins C, E, B1, B2, niacin, B6, folate, and B12) plus zinc, micronutrients without zinc, or a placebo given daily. Children will be followed at monthly clinic visits from age 6 weeks to 18 months, and home visits will occur at the midpoint between study visits. Data obtained will include socioeconomic status, anthropometric data (weight, length, head circumference, and arm anthropometries), dietary intake (including breastfeeding duration and frequency), hemoglobin, ferritin. and blood smear for malaria. The primary outcomes will be the incidence of diarrhea and respiratory tract infections. Secondary outcomes will be weight and length gain. A subset of children will be tested for blood concentrations of vitamin A, E, zinc and C-reactive protein, as well as measures of intestinal permeability. All children will receive a large periodic dose of vitamin A every 6 months as per standard of care in Tanzania. There is a longstanding history of collaboration between Tanzanian researchers and the Harvard School of Public Health, and Drs. Duggan and Fawzi have a long record of collaborative research in a variety of developing country settings. As experts in the fields of nutrition, pediatrics, epidemiology and maternal and child health, our team is committed to further evaluating the possible role of micronutrients in improving child health.