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UnknownNCT02775890

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

Status
Unknown
Phase
Study type
Observational
Enrollment
68 (estimated)
Sponsor
Nelson Marlborough Institute of Technology · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Accepted

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

Interventions

TypeNameDescription
BEHAVIORALEating wild game shot with lead bulletsParticipants will eat meat harvested with lead bullets, prepare mince meat and eat at least a standard serving (\>85 grams).

Timeline

Start date
2019-02-01
Primary completion
2021-02-01
Completion
2021-04-01
First posted
2016-05-18
Last updated
2017-09-18

Source: ClinicalTrials.gov record NCT02775890. Inclusion in this directory is not an endorsement.