Do You Have Adult or Juvenile Dermatomyositis?
This clinical trial is being conducted to evaluate the effect of omega-3 fatty acid (O3FA) supplementation (fish oil) on myositis disease activity and quality of life in adult patients with mild to moderately active Dermatomyositis (DM)/Juvenile Dermatomyositis (JDM). The study will also examine the results of following a healthy diet pattern with O3FA supplements or placebo capsules in adult patients with DM/JDM. Researchers believe that fish oil may decrease dermatomyositis disease activity and improve muscle strength.
Who Can Participate?
- Adults 18-60 years old.
- Experiencing mild to moderately active Dermatomyositis or Juvenile Dermatomyositis.
- Ability to read English and access the internet for completing questionnaires.
- Residents of the United States.
What Is Required?
- Take 4 small fish oil or placebo soft gel capsules twice a day.
- Follow a generally healthy diet and periodically report foods eaten.
- Attend 5 in-person visits over 9 months to the NIH Clinical Center, up to 6 days each. Participate in 2 telehealth visits between in-person visits.
- Provide blood, urine, and stool samples. Get MRIs and other imaging scans.
- Participate in dietary education and coaching.
- Wear a watch-like device that will track your activity level and sleep patterns.
What is Provided to Participants for Participation?
- Compensation up to $800.
- Healthcare evaluations and testing, dietary coaching and study medication are provided at no cost.
Who Is Running the Study?
The study is run by physicians at the National Institute of Environmental Health Sciences (NIEHS), National Institutes of Health, U.S. Department of Health and Human Services.
Study Principal Investigator
Head, Environmental Autoimmunity Group
Pediatric Rheumatologist
Lisa Rider, M.D. is Deputy Chief of the Environmental Autoimmunity Group, and a pediatric rheumatologist with an international reputation for her work on juvenile myositis. She received her B.A. and M.D. from Duke University, completed a pediatrics residency at Seattle Children’s Hospital of University of Washington, and her fellowship in pediatric rheumatology at Seattle Children’s Hospital, Children’s National Medical Center, Washington D.C. and the National Institute of Arthritis and Musculoskeletal and Skin Diseases, National Institutes of Health, Bethesda, MD. She then joined Dr. Frederick Miller’s group in the Center for Biologics Evaluation and Research, Food and Drug Administration and subsequently moved to NIEHS in Bethesda, MD. Dr. Rider’s work has been focused on environmental and genetic risk factors, phenotypes, pathogenesis, outcomes, evaluation, and therapeutic trials in juvenile myositis and other systemic pediatric rheumatic diseases. She has co-led national and international myositis collaborative research groups, and authored from than 170 research publications, reviews, books, and book chapters. She has received several awards of distinction.
Research Webpage
Lead Associate Investigator
Deputy Head, Environmental Autoimmunity Group
Adult Rheumatologist
Adam I. Schiffenbauer, M.D.
adam.schiffenbauer@nih.gov
Adam Schiffenbauer, M.D. is an Associate Research Physician in the Environmental Autoimmunity Group, and an adult rheumatologist with an expertise in myositis. He received his B.A. from The University of Chicago and his M.D. from Pennsylvania State University. He completed an internal medicine residency at George Washington University, and his fellowship in rheumatology at the National Institute of Arthritis and Musculoskeletal and Skin Diseases, National Institutes of Health, Bethesda, MD. He then joined Dr. Frederick Miller’s group in NIEHS in Bethesda, MD. Dr. Schiffenbauer’s work has been focused on environmental and genetic risk factors, phenotypes, pathogenesis, advanced imaging, evaluation, and therapeutic trials in myositis.
Study Coordinator
Julia I. Agafonova
julia.agafonova@nih.gov
For More Information About This Study
- Call: 1-800-411-1222 (se habla español) or TTY: 1-866-411-1010 (Refer to the protocol number below when contacting us about this study.)
- Email: ccopr@nih.gov
- Protocol Number: IRB001790
- Study Background and Protocols