Potential Lead Exposure Through Eating Self-harvested Wild Game

NCT02775890 | Unknown

• 1 other identifier: 1NMIT2016
• Study Type: observational
• Target: 68
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Lead; Toxicology

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

Study Arms (2)

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

Not eating lead-shot wild game

Hunters that have not eaten lead-shot in the past week will have blood lead levels measured.

Interventions

Eating wild game shot with lead bullets BEHAVIORAL

Participants will eat meat harvested with lead bullets, prepare mince meat and eat at least a standard serving (\>85 grams).

Eating lead-shot wild game

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Hunters eating self-harvested wild game with lead bullets.

You may qualify if:

• New Zealand firearms license

You may not qualify if:

• 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

Sponsors & Collaborators

• Nelson Marlborough Institute of Technology: lead
• Mayo Clinic: collaborator

Related Publications (5)

• 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.

  PMID: 26797078 BACKGROUND

• 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.

  PMID: 27456932 BACKGROUND

• 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.

  PMID: 27344321 BACKGROUND

• 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.

  PMID: 27272923 BACKGROUND

• 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.

  PMID: 29740629 DERIVED

Study Officials

• Eric J Buenz, PhD

  Nelson Marlborough Institute of Technology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Matt Peacey, PhD

CONTACT

+64 3 546 9175; Matt.Peacey@nmit.ac.nz

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2016
• First Posted: May 18, 2016
• Study Start: February 1, 2019
• Primary Completion: February 1, 2021
• Study Completion: April 1, 2021
• Last Updated: September 18, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share