Health Effects Following Use of Lead Free Ammunition Used With HK416

October 13, 2013 updated by: Svein Grahnstedt, Oslo University Hospital

In Norwegian: Helseffekter av Stoff Som Avgis Ved Skyting Med HK416

The purpose of this study is to determine whether use of lead free ammunitions cause more respiratory problems than use of lead containing ammunitions.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

55

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
    • Akershus
      • Kjeller, Akershus, Norway, N-2007
        • Norwegian Defence Research Establishment

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

Voluntary army soldiers

Description

Inclusion Criteria:

  • healthy volunteers

Exclusion Criteria:

  • active respiratory disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Leaded ammunition
Non-leaded ammunition
Modified non-leaded ammunition

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Forced Expiratory Volume (FEV1)
Time Frame: Before, Immediately after, and 24 hrs after exposure
Before, Immediately after, and 24 hrs after exposure

Secondary Outcome Measures

Outcome Measure
Time Frame
Inflammation markers
Time Frame: Before and 24 hrs after esposure
Before and 24 hrs after esposure

Other Outcome Measures

Outcome Measure
Time Frame
Subjective Symptoms
Time Frame: During exposure, and during the 24 hrs after exposure
During exposure, and during the 24 hrs after exposure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oslo University Hospital

Collaborators

Norwegian Defence Research Establishment

Investigators

  • Study Director: Kjetil Longva, PhD, Norwegian Defence Reasearch Establishment
  • Principal Investigator: Anne-Katrine Borander, MD, Oslo University Hospital
  • Principal Investigator: Øyvind Albert Voie, PhD, Norwegian Research Defence Establishment
  • Study Director: Johny S Kongerud, MD PhD, Oslo University Hospital
  • Principal Investigator: Liv Ingunn Bjoner Sikkeland, PhD, Oslo University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2011

Primary Completion (Actual)

January 1, 2012

Study Completion (Actual)

March 1, 2012

Study Registration Dates

First Submitted

November 18, 2011

First Submitted That Met QC Criteria

November 21, 2011

First Posted (Estimate)

November 22, 2011

Study Record Updates

Last Update Posted (Estimate)

October 16, 2013

Last Update Submitted That Met QC Criteria

October 13, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011/1335

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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