LeadNCT02775890
Potential Lead Exposure Through Eating Self-harvested Wild Game
An observational study of Lead and Toxicology, run by Nelson Marlborough Institute of Technology.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lead, Toxicology
- What is being tested?
- Eating wild game shot with lead bullets
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 68 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2019to 1 Apr 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Hunters eating self-harvested wild game with lead bullets.
Who may be able to join
- New Zealand firearms license
Who cannot join
- 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)
Show all 23Show fewer
- 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
- paint removal
- sandblasting
- leadlight window manufacture
- lead casting, e.g. fishing weights, toy soldiers
- radiator repair,
- car exhaust repair and engine reconditioning (for older makes and models of vehicles)
- jewellery (silver) production
- shooting range
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
- Conditions
- Lead, Toxicology
- Being tested
- Eating wild game shot with lead bullets
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eating wild game shot with lead bulletsBehavioural
Participants will eat meat harvested with lead bullets, prepare mince meat and eat at least a standard serving (>85 grams).
| Study group | Role | What they receive |
|---|---|---|
| Eating lead-shot wild game | Hunters that have eaten lead-shot in the past week will have blood lead levels measured. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within one year, after participants have eaten a meal (>85grams) of lead-shot meat
Secondary outcomes (3)
Complete blood cell counts
Paired-t tests comparing data from the complete blood count will be performed
Measured: Within one year, after participants have eaten a meal (>85grams) of lead-shot meat
Correlation between lead levels and complete blood cell counts
Measured: At close of study, within one year
Correlation between lead bullet mass and blood lead levels
Measured: At close of study, within one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2016 (estimated)
- Study start1 Feb 2019 (estimated)
- Primary completion1 Feb 2021 (estimated)
- Study completion1 Apr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for LeadStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nelson Marlborough Institute of Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Mayo Clinic
- Responsible party
- Sponsor
- Investigators
- Eric J Buenz, PhD, Principal investigator, Nelson Marlborough Institute of Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02775890
- Sponsor's protocol ID
- 1NMIT2016
- Status last verified
- Sep 2017
- First submitted
- 10 May 2016
- Last updated
- 18 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 26797078Buenz 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.
PubMed 27456932Buenz 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.
PubMed 27344321Buenz 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.
PubMed 27272923Buenz 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.
PubMed 29740629
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Observational Cohort Study Assessing the Feasibility of Measuring Serum Lead Levels in New Zealand Hunters Using Lead Projectiles
- ClinicalTrials.gov ID
- NCT02775890
- Acronym / sponsor ID
- 1NMIT2016
- Conditions
- Lead, Toxicology
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Nelson Marlborough Institute of TechnologyUniversity, hospital or other
- Collaborators
- Mayo Clinic
- Study start
- 1 Feb 2019 (estimated)
- Primary completion
- 1 Feb 2021 (estimated)
- Study completion
- 1 Apr 2021 (estimated)
- First posted
- 18 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Eating lead-shot wild game | – | Behavioral: Eating wild game shot with lead bulletsHunters that have eaten lead-shot in the past week will have blood lead levels measured. |
| Not eating lead-shot wild game | – | –Hunters that have not eaten lead-shot in the past week will have blood lead levels measured. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Hunters eating self-harvested wild game with lead bullets.
Key inclusion criteria (1 listed)
- New Zealand firearms license
Key exclusion criteria (23 listed)
- Smoker
- Any type of kidney dysfunction
- Individuals working in the following industries that may entail lead exposure:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Eating 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). | Behavioural | Eating lead-shot wild game |
Primary outcome
Lead levels
Time frame: Within one year, after participants have eaten a meal (>85grams) of lead-shot meat
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.
3 secondary outcomes
Complete blood cell counts
Time frame: Within one year, after participants have eaten a meal (>85grams) of lead-shot meat
Correlation between lead levels and complete blood cell counts
Time frame: At close of study, within one year
Correlation between lead bullet mass and blood lead levels
Time frame: At close of study, within one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2017.
- Background: PubMed 26797078Buenz 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.
- Background: PubMed 27456932Buenz 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.
- Background: PubMed 27344321Buenz 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.
- Background: PubMed 27272923Buenz 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.
- Derived from this study: PubMed 29740629Buenz 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric J Buenz, PhD principal investigator
Nelson Marlborough Institute of Technology
Questions about this trial
What is this clinical trial studying?
An observational study of Lead and Toxicology, run by Nelson Marlborough Institute of Technology.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Matt Peacey, PhD (+64 3 546 9175, Matt.Peacey@nmit.ac.nz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lead levels (time frame: Within one year, after participants have eaten a meal (>85grams) of lead-shot meat). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02775890, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2017.