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临床试验/NCT02775890
NCT02775890Unknown不适用

A Prospective Observational Cohort Study Assessing the Feasibility of Measuring Serum Lead Levels in New Zealand Hunters Using Lead Projectiles

Nelson Marlborough Institute of Technology0 个研究点目标入组 68 人开始时间: 2019年2月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
68
主要终点
Lead levels

研究概览

简要总结

This is a clinical research protocol to determine the feasibility of assessing lead levels in hunters who use lead projectiles. This study will determine if it is possible to perform an interventional double-blind placebo-controlled study of lead levels in hunters using lead or lead-free projectiles following consumption of self-harvested wild game. The hypothesis for the subsequent study is that minute lead particles from shrapnel dispersed through the animal during harvest are ingested and result in increased lead serum levels. This current observational study establishes if this conclusive interventional study is possible through establishing if hunters using lead projectiles in New Zealand have elevated lead levels after eating animals harvested with lead projectiles. This study will be conducted in compliance with the protocol, Good Clinical Practice Standards, associated regulations and institutional research requirements.

This study aims to assess if hunters eating meat shot with lead projectiles experience elevated lead levels. Hunters will be asked to provide blood samples 2-4 days after they eat meat harvested with lead bullets and provide a subsequent sample when they have abstained from eating wild game harvested with lead bullets. We have chosen to use deer as the species for this study to reduce variation and New Zealand is the ideal place to conduct this study because of year-round hunting of deer. This design will allows paired testing of subject lead levels.

研究设计

研究类型
Observational
观察模型
Case Crossover
时间视角
Prospective

入排标准

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

入选标准

  • New Zealand firearms license

排除标准

  • Any type of kidney dysfunction
  • Individuals working in the following industries that may entail lead exposure:
  • lead-acid battery manufacture
  • lead smelting
  • non-ferrous smelting and casting (e.g. brass)
  • steel scrap smelting
  • scrap lead metal handling
  • cutting/welding steel scrap
  • machining or polishing lead-containing alloys
  • plastic production (where lead compounds are used as stabilisers)
  • lead soldering
  • plastic recycling
  • panel beating
  • paint removal
  • sandblasting
  • leadlight window manufacture
  • lead casting, e.g. fishing weights, toy soldiers
  • radiator repair,
  • car exhaust repair and engine reconditioning (for older makes and models of vehicles)
  • jewellery (silver) production
  • shooting range

结局指标

主要结局

Lead levels

时间窗: Within one year, after participants have eaten a meal (>85grams) of lead-shot meat

A paired t-test will be conducted comparing lead levels in participants when eating wild game harvested with lead projectiles and when participants have not eaten wild game harvested with lead projectiles.

次要结局

  • Complete blood cell counts(Within one year, after participants have eaten a meal (>85grams) of lead-shot meat)
  • Correlation between lead levels and complete blood cell counts(At close of study, within one year)
  • Correlation between lead bullet mass and blood lead levels(At close of study, within one year)

研究者

发起方
Nelson Marlborough Institute of Technology
申办方类型
Other
责任方
Sponsor

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