Trial of Vitamins among Children of HIV-infected Mothers

对感染艾滋病毒的母亲的孩子进行维生素试验

• 批准号: 6591403
• 负责人: Wafaie W Fawzi
• 金额: $ 57.93万
• 依托单位: HARVARD SCHOOL OF PUBLIC HEALTH
• 依托单位国家: 美国
• 财政年份: 2003
• 资助国家: 美国
• 起止时间: 2003-06-09 至 2008-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6591403
• 关键词: AIDS /HIV diagnosis; Africa; HIV infections; ascorbate; breast feeding; child (0-11); child physical development; clinical research; clinical trials; cooperative study; diarrhea; dietary supplements; disease /disorder proneness /risk; human morbidity; human mortality; human subject; human therapy evaluation; longitudinal human study; outcomes research; pathologic process; patient oriented research; respiratory infections; tocopherols; vertical transmission; vitamin B12; vitamin therapy; women's health

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.

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。例如，我们最近在艾滋病毒呈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、流产和低出生体重的情况显着减少。我们和其他人已经在儿童中展示了补充维生素 A 对减少腹泻病和死亡率的有益作用。我们的下一个优先事项是评估多种微量营养素补充剂对易感儿童的功效。由于饮食摄入不良、吸收不良和代谢需求增加，感染艾滋病毒的妇女所生的孩子面临多种微量营养素缺乏的风险。此外，这些儿童如果自己感染了艾滋病毒，则因传染病死亡的风险明显高于未感染艾滋病毒的同龄人。在本申请中，我们建议研究微量营养素补充剂在降低艾滋病毒阳性坦桑尼亚妇女所生婴儿和幼儿的死亡风险和其他不良健康结果方面的功效。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、呼吸道感染、体重和身长增加以及艾滋病毒传播。一部分婴儿将接受肠道通透性评估和生化营养评估。该研究将由哈佛大学公共卫生学院和坦桑尼亚达累斯萨拉姆穆希姆比利大学健康科学学院合作进行。