Nutrition, Arsenic and Cognitive Function in Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 239
- 试验地点
- 1
- 主要终点
- Change in in blood arsenic
研究概览
简要总结
The main goals of this study are to evaluate whether supplementation with folate and vitamin B12 to 8 to 10 year old children, in conjunction with reduction in arsenic exposure, can increase arsenic methylation and lower blood arsenic and blood monomethyl arsenic (as previously observed in adults). The investigators will also explore whether folate and B12 can mitigate arsenic-related decrements in cognitive abilities.
详细描述
While reducing arsenic (As) exposure in Bangladesh and the U.S. must continue to be a top priority, this has proven difficult. After decades of efforts to reduce exposure, 42 million people in Bangladesh remain exposed to As above 10 µg/L, the WHO guideline for As in drinking water. Risk for arsenic-related health outcomes lingers for decades after exposure has been reduced. Innovative strategies to lower arsenic exposure and and reduce its potential adverse health effects of As are needed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
All participants, field staff, and investigators will be blinded to the intervention status of participants.
入排标准
- 年龄范围
- 8 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age-eligible children of parents enrolled in the Health Effects of Arsenic Longitudinal Study cohort
排除标准
- •children who are not attending school
- •children with known physical disability or known chronic illness
结局指标
主要结局
Change in in blood arsenic
时间窗: Up to 12 Weeks
Change in arsenic level in blood is to be measured in mg/L. This is an indicator of the body burden of arsenic and arsenic excretion
Change in arsenic methylation
时间窗: Up to 12 Weeks
Change in arsenic methylation patterns in blood and urine. The ability to methylate arsenic influences an individual's ability to excrete it in urine.
Change in blood monomethyl arsenic
时间窗: Up to 12 Weeks
Change in monomethyl arsenic level in blood is to be measured in units of ug/L. This is an indicator of the body burden of arsenic and arsenic methylation capacity.
次要结局
未报告次要终点
研究者
Mary Gamble
Associate Professor of Environmental Health Sciences
Columbia University