Potential Lead Exposure Through Eating Self-harvested Wild Game

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

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.

Study Overview

• Status: Unknown
• Conditions: Lead; Toxicology
• Intervention / Treatment: Behavioral: Eating wild game shot with lead bullets

• Study Type: Observational
• Enrollment (Anticipated): 68

Contacts and Locations

• Study Contact: Name: Matt Peacey, PhD; Phone Number: +64 3 546 9175; Email: Matt.Peacey@nmit.ac.nz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Hunters eating self-harvested wild game with lead bullets.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Crossover
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Nelson Marlborough Institute of Technology
• Collaborators: Mayo Clinic
• Investigators: Principal Investigator: Eric J Buenz, PhD, Nelson Marlborough Institute of Technology

Publications and helpful links

General Publications

• Buenz EJ. Lead Exposure Through Eating Wild Game. Am J Med. 2016 May;129(5):457-8. doi: 10.1016/j.amjmed.2015.12.022. Epub 2016 Jan 18. No abstract available.
• Buenz EJ. Eliminating potential lead exposure in imported New Zealand wild game. Public Health. 2016 Oct;139:236-237. doi: 10.1016/j.puhe.2016.06.025. Epub 2016 Jul 22. No abstract available.
• Buenz EJ, Parry GJ, Peacey M. Consumption of wild-harvested meat from New Zealand feral animals provides a unique opportunity to study the health effects of lead exposure in hunters. Ambio. 2016 Sep;45(5):629-31. doi: 10.1007/s13280-016-0798-1. Epub 2016 Jun 25. No abstract available.
• Buenz EJ. Non-lead ammunition may reduce lead levels in wild game. Environ Sci Pollut Res Int. 2016 Aug;23(15):15773. doi: 10.1007/s11356-016-7020-7. Epub 2016 Jun 8. No abstract available.
• Buenz EJ, Parry GJ, Bauer BA, Matheny LM, Breukel K. A prospective observational study assessing the feasibility of measuring blood lead levels in New Zealand hunters eating meat harvested with lead projectiles. Contemp Clin Trials Commun. 2017 Feb 8;5:137-143. doi: 10.1016/j.conctc.2017.02.002. eCollection 2017 Mar.

Study record dates

Study Major Dates

• Study Start (Anticipated): February 1, 2019
• Primary Completion (Anticipated): February 1, 2021
• Study Completion (Anticipated): April 1, 2021

Study Registration Dates

• First Submitted: May 10, 2016
• First Submitted That Met QC Criteria: May 15, 2016
• First Posted (Estimate): May 18, 2016

Study Record Updates

• Last Update Posted (Actual): September 18, 2017
• Last Update Submitted That Met QC Criteria: September 14, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: 1NMIT2016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No