Health Effects Following Use of Lead Free Ammunition Used With HK416

This study has been completed.
Sponsor:
Collaborator:
Norwegian Defence Research Establishment
Information provided by (Responsible Party):
Svein Grahnstedt, Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT01477645
First received: November 18, 2011
Last updated: October 13, 2013
Last verified: October 2013
  Purpose

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


Condition
Lung Function Tests
Markers of Inflammation

Study Type: Observational
Study Design: Observational Model: Ecologic or Community
Time Perspective: Prospective
Official Title: In Norwegian: Helseffekter av Stoff Som Avgis Ved Skyting Med HK416

Further study details as provided by Oslo University Hospital:

Primary Outcome Measures:
  • Forced Expiratory Volume (FEV1) [ Time Frame: Before, Immediately after, and 24 hrs after exposure ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Inflammation markers [ Time Frame: Before and 24 hrs after esposure ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Subjective Symptoms [ Time Frame: During exposure, and during the 24 hrs after exposure ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Sputum and serum


Enrollment: 55
Study Start Date: November 2011
Study Completion Date: March 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Leaded ammunition
Non-leaded ammunition
Modified non-leaded ammunition

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Voluntary army soldiers

Criteria

Inclusion Criteria:

  • healthy volunteers

Exclusion Criteria:

  • active respiratory disease
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01477645

Locations
Norway
Norwegian Defence Research Establishment
Kjeller, Akershus, Norway, N-2007
Sponsors and Collaborators
Oslo University Hospital
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
  More Information

No publications provided

Responsible Party: Svein Grahnstedt, Senior Consultant MD PhD, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT01477645     History of Changes
Other Study ID Numbers: 2011/1335
Study First Received: November 18, 2011
Last Updated: October 13, 2013
Health Authority: Norway: Ethics Committee

Additional relevant MeSH terms:
Inflammation
Pathologic Processes

ClinicalTrials.gov processed this record on April 16, 2014