Trial of Vitamins among Children of HIV-infected Mothers

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发病率和死亡率方面的功效。例如，我们最近在艾滋病毒阳性的坦桑尼亚妇女中完成了一项多种微量营养素补充试验，结果显示早产、胎儿丢失和低出生体重显著减少。在儿童中，我们和其他人已经证明了补充维生素A在减少腹泻疾病和死亡率方面的有益作用。我们的下一个重点是评估在易感儿童中补充多种微量营养素的效果。感染艾滋病毒的妇女所生的孩子由于饮食摄入不足、吸收不良和代谢需要增加，有多种微量营养素缺乏的危险。此外，如果这些儿童本身感染了艾滋病毒，他们死于传染病的风险要比未感染的同龄人高得多。在这项应用中，我们建议研究微量营养素补充在降低艾滋病毒阳性坦桑尼亚妇女所生婴幼儿的死亡风险和其他不良健康后果方面的功效。婴儿将被招募并随机分配每天服用微量营养素或安慰剂液体。主要结果将是死亡率。次要结局包括腹泻的发生、呼吸道感染的发生、体重和身高的增加以及HIV的传播。一部分婴儿将接受肠通透性评估和生化营养评估。这项研究将作为哈佛大学公共卫生学院和坦桑尼亚达累斯萨拉姆Muhimbili大学卫生科学学院之间的一项合作努力进行。

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. For example, we have recently completed a multiple micronutrient supplementation trial in HIV-positive Tanzanian women that showed a significant reduction in pre-term birth, fetal loss, and low birthweight. In children, we and others have shown the beneficial effects of vitamin A supplementation in reducing diarrheal disease and mortality. Our next priority is to evaluate the efficacy of multiple micronutrient supplementation in susceptible children. Children born to HIV-infected women are at risk of multiple micronutrient deficiencies due to poor dietary intake, malabsorption, and increased metabolic needs. In addition, these children, if infected with HIV themselves, are at significantly higher risk of death due to infectious illnesses than their non-infected peers. In this application, we propose to study the efficacy of micronutrient supplementation in reducing the risk of death and other adverse health outcomes among infants and young children born to HIV-positive Tanzanian women. Infants will be recruited and randomly assigned to either micronutrients or a placebo liquid given daily. The primary outcome will be mortality. Secondary outcomes will include occurrence of diarrhea, occurrence of respiratory tract infection, weight and length gain, and HIV transmission. A subset of infants will undergo evaluation of intestinal permeability and biochemical nutritional assessment. The study will be carried out as a collaborative effort between the Harvard School of Public Health and Muhimbili University College of Health Sciences, Dar-es-Salaam, Tanzania.