A Trial of Zinc and Micronutrients in Tanzanian Children

坦桑尼亚儿童的锌和微量营养素试验

• 批准号: 7034788
• 负责人: CHRISTOPHER P DUGGAN
• 金额: $ 42.56万
• 依托单位: HARVARD SCHOOL OF PUBLIC HEALTH
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-08-10 至 2011-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7034788
• 关键词: ascorbate; clinical research; clinical trials; developmental nutrition; diarrhea; diet therapy; dietary supplements; enzyme linked immunosorbent assay; folate; human subject; human therapy evaluation; infant human (0-1 year); niacin; nutrition related tag; oral administration; respiratory disorder; riboflavin; thiamine; tocopherols; vitamin B12; vitamin B6; zinc

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.

描述（由申请人提供）：越来越多的证据支持单一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功效。我们对艾滋病毒呈阳性的坦桑尼亚妇女进行的多种微量营养素补充试验表明，早产、流产和低出生体重的情况显着减少。此外，补充补充剂的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对易感儿童的功效。在此应用中，我们计划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 阴性女性所生的婴儿 (n=2400)，并通过因子设计随机分配给锌、微量营养素（维生素 C、E、B1、B2、烟酸、B6、叶酸和 B12）以及锌、微量营养素不含锌，或每天服用安慰剂。儿童在 6 周至 18 个月大期间将每月进行一次诊所随访，并在研究访问的中间进行家访。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数据）、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。以及疟疾的血涂片。主要结果是腹泻和呼吸道感染的发生率。次要结果是体重和长度增加。将测试部分儿童的血液维生素 A、E、锌和 C 反应蛋白浓度，以及肠道通透性测量。根据坦桑尼亚的护理标准，所有儿童将每 6 个月定期接受大剂量的维生素 A。坦桑尼亚研究人员与哈佛大学公共卫生学院之间有着悠久的合作历史，博士。杜根和法齐在各种发展中国家环境中有着长期的合作研究记录。作为营养学、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的可能作用。