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: 7062141
• 负责人: Wafaie W Fawzi
• 金额: $ 48.16万
• 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/7062141
• 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了单一和最近补充多种微量营养素在降低易感人群的发病率和死亡率方面的功效。例如，我们最近在HIV阳性坦桑尼亚妇女中完成了一项多种微量营养素补充试验，该试验显示出前期出生，胎儿丧失和低出生体重的显着减少。在儿童中，我们和其他人表现出补充维生素A在降低腹泻疾病和死亡率中的有益作用。我们的下一个优先级是评估易感儿童多种微量营养素补充剂的功效。艾滋病毒感染的妇女出生的儿童由于饮食不良，吸收不良和代谢需求增加而面临多种微量营养素缺陷的风险。此外，如果感染了艾滋病毒，这些儿童因传染病而与未感染的同龄人相比，死亡风险明显更高。在此应用中，我们建议研究补充微量营养素在降低死亡的风险和其他不良健康结果的疗效，以及HIV阳性坦桑尼亚妇女所生的幼儿。婴儿将被招募并随机分配给微量营养素或每天给予的安慰剂液体。主要结果将是死亡率。次要结局将包括腹泻，呼吸道感染的发生，体重和长度增益以及HIV传播。一部分婴儿将接受肠道通透性和生化营养评估的评估。这项研究将作为哈佛大学公共卫生学院与坦桑尼亚州达 - 萨拉姆的穆希姆比利大学健康科学学院之间的合作努力进行。