Environmental Risk Factors for Myositis in Military Personnel
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|ClinicalTrials.gov Identifier: NCT01734369|
Recruitment Status : Active, not recruiting
First Posted : November 27, 2012
Last Update Posted : August 12, 2022
- Myositis is a rare disease in which the body s immune cells attack the muscle tissue. It can cause muscle weakness, swelling, and pain. It can develop in people with no history of muscle problems. Environmental exposures may determine who develops myositis. Genes may also affect development of the disease.
- Some people who serve in the military develop myositis. However, other military personnel do not. Researchers want to compare military personnel with and without myositis. They will look for common factors that might have led to the disease.
- To study environmental risk factors for myositis in military personnel.
- Military personnel who developed myositis during their period of service.
- Healthy military personnel who do not have myositis or another autoimmune disease.
- Participants will have a physical exam and medical history.
- Participants will fill out forms about environmental exposures, particularly while in the military. The questions will ask about past infections, vaccines and medications, and personal habits. They will also ask about participants occupations during military service and their deployments.
- Participants will also provide blood samples for study.
- No treatment will be provided as part of this study.
|Condition or disease|
|Dermatomyositis Adult Polymyositis Inclusion Body Myositis Myositis|
|Study Type :||Observational|
|Actual Enrollment :||37 participants|
|Official Title:||Environmental Risk Factors for the Development of Myositis in Military Personnel|
|Actual Study Start Date :||March 13, 2014|
|Actual Primary Completion Date :||October 31, 2021|
|Estimated Study Completion Date :||December 31, 2022|
Healthy Control Subjects
Military service members active duty or no longer in duty, military contractors, and civilians working for the military. Controls should be without a recognized autoimmune or chronic muscle disease.
Diagnosis of myositis during military service or service as a military contractor or civilian working for the military with polymyositis, dermatomyositis, or inclusion body myositis.
- Military Myositis Questionnaire [ Time Frame: Assessed once per respondent ]Myositis and control subjects will complete the environmnetal exposure questionnaire, a connective tissue screening questionnaire and the Patient Reported Outcomes Measurement Information System (PROMIS) Quality of Life measure to assess health related quality of life
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 ClinicalTrials.gov identifier (NCT number): NCT01734369
|United States, Maryland|
|Walter Reed National Medical Center|
|Bethesda, Maryland, United States, 20301|
|National Institutes of Health Clinical Center|
|Bethesda, Maryland, United States, 20892|
|United States, North Carolina|
|NIEHS Clinical Research Unit (CRU)|
|Research Triangle Park, North Carolina, United States, 27709|
|Principal Investigator:||Adam I Schiffenbauer, M.D.||National Institute of Environmental Health Sciences (NIEHS)|