Potential Lead Exposure Through Eating Self-harvested Wild Game

NCT ID: NCT02775890

Last Updated: 2017-09-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

68 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-02-01

Study Completion Date

2021-04-01

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.

Detailed Description

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Conditions

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Lead Toxicology

Study Design

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Observational Model Type

CASE_CROSSOVER

Study Time Perspective

PROSPECTIVE

Study Groups

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Eating lead-shot wild game

Hunters that have eaten lead-shot in the past week will have blood lead levels measured.

Eating wild game shot with lead bullets

Intervention Type BEHAVIORAL

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.

No interventions assigned to this group

Interventions

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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).

Intervention Type BEHAVIORAL

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:

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mayo Clinic

OTHER

Sponsor Role collaborator

Nelson Marlborough Institute of Technology

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Eric J Buenz, PhD

Role: PRINCIPAL_INVESTIGATOR

Nelson Marlborough Institute of Technology

Central Contacts

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Matt Peacey, PhD

Role: CONTACT

+64 3 546 9175

References

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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.

Reference Type BACKGROUND
PMID: 26797078 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27456932 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27344321 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27272923 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29740629 (View on PubMed)

Other Identifiers

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1NMIT2016

Identifier Type: -

Identifier Source: org_study_id