Effects of Supplementation With Zinc and Other Micronutrients on the Health and Development of African Children
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 612
- 试验地点
- 1
- 主要终点
- Febrile malaria episodes
研究概览
简要总结
The purpose of this study is to determine to what extent supplementation with zinc and other micronutrients are efficacious in preventing malaria in young Tanzanian children.
详细描述
Zinc is essential for the functioning of the immune system. Supplementation trials in Asia, Latin America, the Pacific and developed countries have shown that increasing zinc intake has great potential to control common infections in children, but the response to supplementation may be different in Africa, where the primary environmental challenge to children's health is malaria. Simultaneous supplementation with other potentially limiting nutrients may be required to overcome a lack of response when zinc is given alone. The project aims at measuring effects of daily oral supplementation with zinc and other micronutrients, given either alone or in combination, on malaria incidence and nutritional status, and on indicators of immunity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Months 至 60 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 6-60 months
- •Permanently residing in the study area
- •Being moderately or mildly stunted (height-for-age z-score <-1.5 SD)
- •Informed consent from parents or guardians obtained
排除标准
- •Severe wasting (weight-for-height z-score <-3 SD)
- •Hemoglobin concentration <70 g/L
- •Axillary temperature ≥37.50 °C with malaria antigenemia
- •Signs and symptoms at randomisation suggesting malaria, hepatitis, HIV/AIDS, tuberculosis, sickle cell disease or other severe condition
- •Unable to produce a venous blood sample (>1 mL)
结局指标
主要结局
Febrile malaria episodes
时间窗: 60 weeks
次要结局
- T cell immune responses to in vitro stimulation with a crude Plasmodium falciparum lysate(30 weeks after start of intervention)
- Haematologic and urinary indicators of micronutrient status(30 weeks after start of intervention)
- Anthropometric indices(57 weeks after start of intervention)
- Plasma immunoglobulin concentrations(2 weeks after malaria episodes)