FAST for DM – Fatty Acid Supplementation Trial (FAST) for Dermatomyositis (DM) | National Institute of Environmental Health Sciences
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FAST for DM – Fatty Acid Supplementation Trial (FAST) for Dermatomyositis (DM)
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NIH Clinical Studies
Dermatomyositis is a rare autoimmune disease that causes muscle weakness and skin rashes. This clinical trial is testing the effects of Omega-3 Fatty Acid (O3FA) supplementation and a healthful diet pattern in adult patients with mild to moderately active dermatomyositis or in juvenile dermatomyositis (DM/JDM). This randomized, placebo-controlled trial will evaluate the effects of O3FA and diet on myositis disease activity, including muscle strength and function, other elements of disease activity, and quality of life. The estimated duration of participation is nine months, with an option to continue for an additional three months in an open-label extension. The clinical trial is conducted at the NIH Clinical Center in Bethesda, Maryland. Compensation up to $800 is available.
Eligibility Criteria
Confirmed DM/JDM diagnosis with mild to moderate disease activity.
Elevation of at least one of the muscle enzymes [which include creatine kinase (CK), aldolase, lactate dehydrogenase (LDH), ALT and AST] at a minimum level of 1.3 times the upper limit of normal.
Participants ages 18-60 years old, not currently pregnant or breastfeeding.
Residents of the United States and must be able to read in English.
Have reliable access to the internet and email to complete study activities.
Participate in telehealth and dietary coaching appointments with the study investigators.
Must be able to provide their own transportation to study visits at the NIH Clinical Center in Bethesda, Maryland, for a total of five visits, and participate in two telehealth appointments in between.
Willing and able to ingest four small softgel O3FA or placebo capsules twice a day.
Have not taken Omega-3 Fatty Acid or other fish oil supplements in the past six months.
Fish intake of less than two servings per week on average for the past three months.
Intake of meat products or dairy products within two months of the screening visit and have no allergic reaction.
No restrictive dietary habits.
Willing to adhere to the healthy diet pattern and participate in dietary coaching with the nutrition staff.
Ambulatory, without severe cardiomyopathy or arrhythmias, uncontrolled hypertension, and any acute and life-threatening condition unrelated to myositis.
Body Mass Index (BMI) > 18 and ≤ 35 kg/m².
No coagulation or bleeding disorders, or receiving anti-platelet or anti-coagulant medications, including daily aspirin, warfarin, or Plavix.
No antibiotic usage in the past three months.
Currently not taking supplements or medications that affect lipoproteins for the past six months, including statins, bile-acid sequestrants, plant sterol supplements, fibrates, niacin, or PCSK9 inhibitors.
Not participating in another clinical experimental therapeutic study within 30 days of the screening visit or during the study.
What is Provided to Participants?
Thorough health care evaluations, including blood and urine testing, imaging, and other tests.
Dietary coaching with the NIH nutrition staff.
Study supplement provided at no cost.
Optional open-label extension in which all participants receive O3FA and follow-up health evaluations.
Principal Investigator
Lisa G. Rider, M.D.
Head and Senior Clinician
Tel 301-451-6272
[email protected]
Lead Associate Investigator
Adam I. Schiffenbauer, M.D.
Deputy Head and Associate Research Physician
Tel 301-451-6270
[email protected]
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Last Reviewed: April 06, 2026