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临床试验/NCT02719262
NCT02719262已完成不适用

Workplace Intervention and Reduced Ambient Melamine Exposure and Renal Damage in Melamine Tableware Manufacturing Workers

Kaohsiung Medical University Chung-Ho Memorial Hospital2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2016年3月26日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
24
试验地点
2
主要终点
Change of melamine in air and in urine

研究概览

简要总结

The investigators recent study has found that ambient melamine exposure can cause the increase of biomarkers of renal tubular injury in melamine manufacturing workers. Thus, in this year, the investigators will examine whether the intervention by installing ventilation in the workplace and providing personal protective equipment and education can decrease ambient melamine exposure and further decrease urinary biomarkers of renal tubular injury such as N-acetyl β-D-glucosaminidase (NAG) and β2-microglobulin (β2-MG).

详细描述

The investigators through intervention trial design to examine whether the use of ventilation in the workplace can decrease ambient melamine exposure, oxidative stress markers (such as 8-hydoxy-2-deoxyguanosine, malondialdehyde)and indicators of early renal damage (such as N-acetyl β-D-glucosaminidase, microalbumin and β2-microglobulin). The one week before intervention and the second week after intervention, the volunteers were asked to collect their urine samples for one consecutive week during mornings and afternoons. Blood samples were taken on Fridays morning, workplace air was sampled for 5 consecutive days. Then the investigators continued to trace the melamine concentration change of volunteers and workplace every three-month intervals after intervention, and blood samples were taken on 12th and 24th month.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

盲法说明

Blinded by lab. persons who analyzed biomarkers

入排标准

年龄范围
20 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • healthy adult over age of 20 years

排除标准

  • any hormone treatment or major chronic diseases (such as: cancer, hypertension, diabetes, chronic kidney disease and chronic liver disease) and patients with urinary calculi or family history of urinary calculi

结局指标

主要结局

Change of melamine in air and in urine

时间窗: 1 weeks

Measured by liquid chromatograph/tandem mass spectrometry

次要结局

  • oxidative stress markers malondialdehyde (MDA)(6 months)
  • Oxidative stress markers 8-hydoxy-2-deoxyguanosine (8-OHdG)(6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ming-Tsang Wu

Director of Center of Environmental & Occupational Medicine

Kaohsiung Medical University Chung-Ho Memorial Hospital

研究点 (2)

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