Potential Lead Exposure Through Eating Self-harvested Wild Game

Lead Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02775890
• Other study ID #: 1NMIT2016
• Status: Not yet recruiting
• Phase: N/A
• First received: May 10, 2016
• Last updated: September 14, 2017
• Start date: February 1, 2019
• Est. completion date: April 1, 2021

Study information

• Verified date: September 2017
• Source: Nelson Marlborough Institute of Technology
• Contact: Matt Peacey, PhD
• Phone: +64 3 546 9175
• Email: Matt.Peacey[@]nmit.ac.nz
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 68
• Est. completion date: April 1, 2021
• Est. primary completion date: February 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lead
• Toxicology

Intervention

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).

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Nelson Marlborough Institute of Technology	Mayo Clinic

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Correlation between lead levels and complete blood cell counts		At close of study, within one year
Secondary	Correlation between lead bullet mass and blood lead levels		At close of study, within one year