Health Effects Following Use of Lead Free Ammunition Used With HK416

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01477645
Recruitment Status : Completed
First Posted : November 22, 2011
Last Update Posted : October 16, 2013
Norwegian Defence Research Establishment
Information provided by (Responsible Party):
Svein Grahnstedt, Oslo University Hospital

Brief Summary:
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 or disease
Lung Function Tests Markers of Inflammation

Study Type : Observational
Actual Enrollment : 55 participants
Observational Model: Ecologic or Community
Time Perspective: Prospective
Official Title: In Norwegian: Helseffekter av Stoff Som Avgis Ved Skyting Med HK416
Study Start Date : November 2011
Actual Primary Completion Date : January 2012
Actual Study Completion Date : March 2012

Leaded ammunition
Non-leaded ammunition
Modified non-leaded ammunition

Primary Outcome Measures :
  1. Forced Expiratory Volume (FEV1) [ Time Frame: Before, Immediately after, and 24 hrs after exposure ]

Secondary Outcome Measures :
  1. Inflammation markers [ Time Frame: Before and 24 hrs after esposure ]

Other Outcome Measures:
  1. Subjective Symptoms [ Time Frame: During exposure, and during the 24 hrs after exposure ]

Biospecimen Retention:   Samples Without DNA
Sputum and serum

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Voluntary army soldiers

Inclusion Criteria:

  • healthy volunteers

Exclusion Criteria:

  • active respiratory disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01477645

Norwegian Defence Research Establishment
Kjeller, Akershus, Norway, N-2007
Sponsors and Collaborators
Oslo University Hospital
Norwegian Defence Research Establishment
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 automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Svein Grahnstedt, Senior Consultant MD PhD, Oslo University Hospital Identifier: NCT01477645     History of Changes
Other Study ID Numbers: 2011/1335
First Posted: November 22, 2011    Key Record Dates
Last Update Posted: October 16, 2013
Last Verified: October 2013

Additional relevant MeSH terms:
Pathologic Processes