NCT01477645

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2011

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2011

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

November 18, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 22, 2011

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

October 16, 2013

Status Verified

October 1, 2013

Enrollment Period

2 months

First QC Date

November 18, 2011

Last Update Submit

October 13, 2013

Conditions

Lung Function TestsMarkers of Inflammation

Outcome Measures

Primary Outcomes (1)

  • Forced Expiratory Volume (FEV1)

    Before, Immediately after, and 24 hrs after exposure

Secondary Outcomes (1)

  • Inflammation markers

    Before and 24 hrs after esposure

Other Outcomes (1)

  • Subjective Symptoms

    During exposure, and during the 24 hrs after exposure

Study Arms (3)

Leaded ammunition

Non-leaded ammunition

Modified non-leaded ammunition

Eligibility Criteria

Age20 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Voluntary army soldiers

You may qualify if:

  • healthy volunteers

You may not qualify if:

  • active respiratory disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Norwegian Defence Research Establishment

Kjeller, Akershus, N-2007, Norway

Location

Related Publications (1)

  • Borander AK, Voie OA, Longva K, Danielsen TE, Grahnstedt S, Sandvik L, Kongerud J, Sikkeland LIB. Military small arms fire in association with acute decrements in lung function. Occup Environ Med. 2017 Sep;74(9):639-644. doi: 10.1136/oemed-2016-104207. Epub 2017 Apr 13.

    PMID: 28408655DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Sputum and serum

Study Officials

  • Kjetil Longva, PhD

    Norwegian Defence Reasearch Establishment

    STUDY DIRECTOR

  • Anne-Katrine Borander, MD

    Oslo University Hospital

    PRINCIPAL INVESTIGATOR

  • Øyvind Albert Voie, PhD

    Norwegian Research Defence Establishment

    PRINCIPAL INVESTIGATOR

  • Johny S Kongerud, MD PhD

    Oslo University Hospital

    STUDY DIRECTOR

  • Liv Ingunn Bjoner Sikkeland, PhD

    Oslo University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Consultant MD PhD

Study Record Dates

First Submitted

November 18, 2011

First Posted

November 22, 2011

Study Start

November 1, 2011

Primary Completion

January 1, 2012

Study Completion

March 1, 2012

Last Updated

October 16, 2013

Record last verified: 2013-10

Locations

NO(1)