Environmental Risk Factors for Myositis in Military Personnel
- Conditions
- MyositisInclusion Body MyositisDermatomyositisAdult Polymyositis
- Registration Number
- NCT01734369
- Lead Sponsor
- National Institute of Environmental Health Sciences (NIEHS)
- Brief Summary
Background:
* 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.
Objectives:
- To study environmental risk factors for myositis in military personnel.
Eligibility:
* Military personnel who developed myositis during their period of service.
* Healthy military personnel who do not have myositis or another autoimmune disease.
Design:
* 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.
- Detailed Description
Myositis, an autoimmune muscle disease, likely develops as a result of environmental exposures in genetically susceptible persons. Preliminary data suggest a trend for an increasing incidence in myositis in military personnel over the last decade for unknown reasons. Although a few environmental exposures have been preliminarily associated with myositis in the civilian population, these have not been confirmed. In addition, no study has assessed exposures that might result in the development of myositis in military personnel. Military personnel experience a number of intense, unique exposures, often over a relatively short interval, which include different stresses, novel vaccines, distinct occupational exposures, battlefield injuries and unique chemicals during field deployment, that differ from those exposures in non-military populations. Therefore, we propose a protocol that consists of three complementary approaches to attempt to determine the environmental factors associated with the development of myositis in active duty military personnel and an initial understanding of the possible mechanisms involved. In the first approach, we will assess risk factors in a case-control study of 300 patients who developed myositis while on active duty by comparing them to 1500 active duty military personnel (randomly selected, but matched 5:1 by gender, race, and age and military service within 10 years) who have not been diagnosed with an autoimmune disease or chronic muscle disease. For this first approach, we will analyze existing military databases for information on medications, vaccines, infections, co-existing medical conditions, military occupations, deployments, and worldwide active duty locations. In the second case-control approach, we will attempt to define environmental factors associated with the development of myositis that developed in military personnel (n=150) by comparing them to 150 similarly matched military personnel who have not been diagnosed with an autoimmune disease or chronic muscle disease. This second approach will differ from the first approach, in that subjects will be prospectively enrolled and assessed during a single clinic visit to confirm diagnoses and examine patient questionnaires on focused environmental exposures, including those not captured in the military databases. A third laboratory approach will identify, in an exploratory study, the global DNA methylation epigenetic changes, microRNA and mRNA profiles in peripheral blood and muscle tissues from 18 subjects (six PM and six DM compared to six non-myositis controls enrolled in the second approach) and assess the effects of selected environmental exposures on these parameters. These complementary approaches should enhance the understanding of environmental factors and possible mechanisms associated with the development of myositis in the military, and provide insights into environmental risk factors that may also be relevant to the development of myositis in non-military populations.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 37
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Military Myositis Questionnaire 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (7)
VA Pittsburgh Healthcare Sys.
🇺🇸Pittsburgh, Pennsylvania, United States
Naval Medical Center, Portsmouth
🇺🇸Portsmouth, Virginia, United States
NIEHS Clinical Research Unit (CRU)
🇺🇸Research Triangle Park, North Carolina, United States
National Institutes of Health Clinical Center
🇺🇸Bethesda, Maryland, United States
Miami VA Healthcare System
🇺🇸Miami, Florida, United States
Walter Reed National Medical Center
🇺🇸Bethesda, Maryland, United States
Madigan Army Medical Center
🇺🇸Tacoma, Washington, United States