NCT02243904进行中（未招募）不适用
Study for Promotion of Health in Recycling Lead
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- KU Leuven
- 入组人数
- 270
- 试验地点
- 1
- 主要终点
- Annual change in systolic blood pressure as measured by 24-h ambulatory monitoring
研究概览
简要总结
Study for Promotion of Health in Recycling Lead (SPHERL) is a prospective 2-year follow-up study of lead workers with exposure levels varying between and within individuals. SPHERL addresses to what extent between-subject differences or within-subject changes in lead exposure may have a measurable impact on blood pressure, the cardiovascular system, renal function, the autonomic nervous system, peripheral nervous conduction velocity, and neurocognitive function.
At the beginning of December 2015, 70 participants were included in the study.
详细描述
Background
- Whether low-level lead exposure impacts on blood pressure, regulation of the cardiovascular system, glomerular or tubular renal function, sympathetic nervous modulation, peripheral nervous conduction velocity, and neurocognitive function remains uncertain.
Study Population
- SPHERL will enroll 500 lead recycling workers with changing lead exposure, who will be examined at baseline (2014-2015) and followed up at annual intervals for 2 years (2016-2017).
Methods
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Women and men are eligible.
- •New hires without previous occupational lead exposure who will be performing tasks with lead exposure or current employees without previous occupational lead exposure moving to tasks with exposure.
- •Informed written consent.
排除标准
- •Pregnancy.
- •Any serious health condition.
结局指标
主要结局
Annual change in systolic blood pressure as measured by 24-h ambulatory monitoring
时间窗: Baseline, 1 year and 2 years
次要结局
- Annual change in heart function(Baseline, 1 year and 2 years)
- Annual change in autonomic nervous function(Baseline, 1 year and 2 years)
- Annual change in peripheral nervous conduction velocity(Baseline, 1 year and 2 years)
- Annual change in quality of life(Baseline, 1 year and 2 years)
- Annual change in central hemodynamics(Baseline, 1 year and 2 years)
- Annual change in renal function(Baseline, 1 year and 2 years)
- Annual change in neurocognitive performance(Baseline, 1 year and 2 years)
研究者
研究点 (1)
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