Potential Lead Exposure Through Eating Self-harvested Wild Game

• Conditions: Toxicology; Lead
• Interventions: Behavioral: Eating wild game shot with lead bullets

• Registration Number: NCT02775890
• Lead Sponsor: Nelson Marlborough Institute of Technology

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-05-10
• Study First Submitted QC: 2016-05-15
• Study First Posted: 2016-05-18
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-14
• Last Update Posted: 2017-09-18
• Study Start: 2019-02-01
• Primary Completion: 2021-02-01
• Study Completion: 2021-04-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 68

Inclusion Criteria

• New Zealand firearms license

Exclusion Criteria

• Smoker

• Any type of kidney dysfunction

• Individuals working in the following industries that may entail lead exposure:

  1. lead-acid battery manufacture
  2. lead smelting
  3. non-ferrous smelting and casting (e.g. brass)
  4. steel scrap smelting
  5. scrap lead metal handling
  6. cutting/welding steel scrap
  7. machining or polishing lead-containing alloys
  8. plastic production (where lead compounds are used as stabilisers)
  9. demolition
  10. lead soldering
  11. plastic recycling
  12. panel beating
  13. paint removal
  14. sandblasting
  15. leadlight window manufacture
  16. lead casting, e.g. fishing weights, toy soldiers
  17. radiator repair,
  18. car exhaust repair and engine reconditioning (for older makes and models of vehicles)
  19. jewellery (silver) production
  20. shooting range

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Eating lead-shot wild game	Eating wild game shot with lead bullets	Hunters that have eaten lead-shot in the past week will have blood lead levels measured.

Primary Outcome Measures

Name	Time	Method
Lead levels	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.

Secondary Outcome Measures

Name	Time	Method
Complete blood cell counts	Within one year, after participants have eaten a meal (>85grams) of lead-shot meat	Paired-t tests comparing data from the complete blood count will be performed
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