Potential Lead Exposure Through Eating Self-harvested Wild Game

Study Overview
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Brief Summary
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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.

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

Conditions
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Lead, Toxicology

Intervention / Treatment
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* Behavioral: Eating wild game shot with lead bullets


Participation Criteria
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Eligibility Criteria
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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: 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) demolition 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Eating lead-shot wild game<br>Hunters that have eaten lead-shot in the past week will have blood lead levels measured. | Behavioral: Eating wild game shot with lead bullets<br>* Participants will eat meat harvested with lead bullets, prepare mince meat and eat at least a standard serving (>85 grams).<br>|
| Not eating lead-shot wild game<br>Hunters that have not eaten lead-shot in the past week will have blood lead levels measured. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lead levels | 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. | Within one year, after participants have eaten a meal (>85grams) of lead-shot meat | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete blood cell counts | Paired-t tests comparing data from the complete blood count will be performed | 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 |