A Trial of Zinc and Micronutrients in Tanzanian Children

描述（由申请方提供）：越来越多的证据支持单一微量营养素补充剂以及最近的多种微量营养素补充剂在降低易感人群发病率和死亡率方面的疗效。我们在坦桑尼亚HIV阳性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，艾滋病毒的传播率和发病率下降，在婴儿的子集补充母亲。由于多种微量营养素缺乏症可能同时发生，并且由于营养素补充之间可能存在协同作用，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功效。在本申请中，我们建议研究锌或多种微量营养素补充剂在降低坦桑尼亚2400名婴幼儿感染性疾病和生长迟缓风险方面的功效。将招募HIV阴性女性所生婴儿（n=2400），并按析因设计随机分配至锌、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给予安慰剂组。将在6周至18个月的每月诊所访视时对儿童进行随访，并在研究访视之间的中点进行家访。获得的数据将包括社会经济状况、人体测量数据（体重、身长、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。血涂片检查疟疾主要结局为腹泻和呼吸道感染的发生率。次要结局是体重和身长增加。一部分儿童将接受维生素A、E、锌和C反应蛋白的血液浓度以及肠道通透性的检测。根据坦桑尼亚的护理标准，所有儿童每6个月将定期接受大剂量的维生素A。坦桑尼亚研究人员与哈佛公共卫生学院之间有着长期的合作历史，Duggan博士和Fawzi博士在各种发展中国家环境中有着长期的合作研究记录。作为营养、儿科、流行病学和妇幼保健领域的专家，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的可能作用。

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.