Zinc, Mental Health, and School Performance
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 750
- 试验地点
- 2
- 主要终点
- Symptoms of depression
研究概览
简要总结
This study will determine whether supplements of the mineral zinc will improve mental health and school performance among schoolchildren in Guatemala.
详细描述
Mental health problems are an important cause of dysfunction throughout the world, accounting for 8.1% of the Global Burden of Disease. The need for interventions that can prevent mental health conditions, particularly among children, cannot be overemphasized. This study will determine whether zinc supplementation improves the mental health and school performance among children in Guatemala.
Participants will be randomly assigned to receive daily supplements of either zinc or placebo for 6 months. Participants will be assessed at study entry and after the 6-month treatment. Participants and their parents and teachers will complete questionnaires about the participants' symptoms of depression and anxiety, concentration and activity levels, school performance, and any environmental stressors to which the participants may be exposed to.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 7 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Attend a public school in specific Guatemalan community and has thorough and up-to-date school records
- •Currently in 2nd to 6th grade
- •Parent or guardian willing to provide informed consent
排除标准
- •Any illness that may affect participants' zinc levels
- •Any chronic illness
- •History of cancer
结局指标
主要结局
Symptoms of depression
时间窗: Baseline and post supplementation
次要结局
- attention problems and school performance(Baseline and post supplementation)
- zinc levels(Baseline and post supplementation)
- activity levels(Baseline and post supplementation)
- Symptoms of anxiety(Baseline and post supplementation)
研究者
Aryeh David Stein
Professor, Global Health
Emory University