Actively Recruiting
FAST for DM - Fatty Acid Supplementation Trial (FAST) for Dermatomyositis (DM)
Led by National Institute of Environmental Health Sciences (NIEHS) · Updated on 2026-05-14
300
Participants Needed
1
Research Sites
284 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Dermatomyositis (DM) is a rare autoimmune disease that causes muscle weakness, skin rashes, and other symptoms. Researchers think both genetic and environmental factors play a role in this disease. They want to find out more about how diet and lifestyle choices affect people with DM/JDM. Objective: To see if omega-3 fatty acid supplements from fish oil, combined with a healthy diet, can help people with DM/JDM. Eligibility: Adults 18-60 years old, who live in the United States, can read English, and access Internet to complete questionnaires can participate. Design: Participants will have 5 or 6 inpatient visits. For 5 visits they may need to stay in the Clinical Center for up to 5 days. Participants will be screened. They will have a physical exam with blood, urine and stool tests. They will have tests of their heart and lung function. Their muscle strength will be measured. They may have an imaging scan of their thighs and pelvis. They will complete online questionnaires about their health and lifestyle. They may complete two optional skin biopsies. Participants will take 4 small capsules by mouth twice a day for up to 6 months. The capsules will contain omega-3 fatty acids from fish oil or a placebo. The placebo looks just like the regular capsule but contains no active ingredients. Participants will not know which capsules they are taking. They will follow a healthy diet based on the General Healthy Eating Pattern. Participants will receive dietary coaching and will have virtual check-ins throughout the study. For two 7-day periods, they will wear a watch-like device to track their daily activity and sleep patterns. Participants may opt to remain in the study for an additional 12 weeks. All will receive the fish oil supplements during this stage.
CONDITIONS
Official Title
FAST for DM - Fatty Acid Supplementation Trial (FAST) for Dermatomyositis (DM)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults 18 to 60 years old with probable or definite dermatomyositis (DM) or juvenile dermatomyositis (JDM) by EULAR-ACR criteria
- Willing to follow the general healthy diet pattern and participate in dietary coaching sessions
- Able and willing to take 4 study capsules twice daily for 6 months
- Able and willing to wear an ActiGraph device at home for 7 continuous days twice during the study
- Willing to complete study tests including blood, stool, urine samples, and imaging
- Able to attend 5 onsite study visits at NIH Clinical Center in Bethesda, Maryland
- Has transportation and willing to pay travel and out-of-pocket expenses
- Owns or has reliable access to a computer, smartphone, or laptop with internet and active email
- Ambulatory and living in the United States
- Proficient in English and able to complete online questionnaires
- Moderately active DM/JDM defined by specific clinical activity scores and lab enzyme levels
- Physician global damage and muscle damage scores less than or equal to 5.0 on a 10 cm scale
- Stable prednisone and methotrexate doses for at least 4 weeks if used, with prednisone dose less than or equal to 20 mg/day
- Stable doses for other immunosuppressive agents for specified durations before week 6 visit
- Required washout periods for immunosuppressive medications before screening
- Negative pregnancy test if female
- Body Mass Index (BMI) greater than 18 and less than or equal to 35 kg/m2
- Fish intake of less than 2 servings per week on average in past 3 months
- Recent intake of meat products without allergic reactions
You will not qualify if you...
- Polymyositis, inclusion body myositis, or cancer-associated myositis diagnosed within 3 years of cancer (except certain skin or cervical cancers)
- Myositis overlapping with autoimmune diseases that prevent accurate treatment assessment or unstable thyroid disease
- Drug- or toxin-induced myositis
- Moderately to severely active myositis requiring new immunosuppressive treatments
- Severe joint disease, calcinosis, or musculoskeletal conditions affecting muscle strength assessment
- Other illnesses posing risk or interfering with assessments, including infections, severe swallowing dysfunction, lipodystrophy, severe heart or lung disease, recent major cardiovascular events, malignancy, uncontrolled hypertension, or psychiatric illness
- Gastrointestinal conditions affecting fat absorption
- Liver disease
- Osteoporotic fractures impacting movement
- Kidney dysfunction
- Bleeding disorders or use of anticoagulants including daily aspirin
- Life-threatening illnesses unrelated to myositis
- Allergies or intolerance to fish oil, placebo ingredients, or related substances
- Known food allergies to certain meats or dairy with recent allergic reactions
- Recent or current use of omega-3 fatty acids, lipid-affecting drugs or supplements, or interacting medications
- Recent antibiotic, antiviral, antifungal, or antiparasitic use (except allowed COVID-19 treatments)
- Unstable hormone treatments
- Uncontrolled diabetes or hyperlipidemia
- Current weight-loss program or recent significant weight changes
- Use of weight or appetite control medications recently
- History of eating disorders
- Recent start of exercise program
- Recent drug or alcohol abuse
- Recent blood donation or planned donation during study
- Pregnant or nursing women or planning pregnancy
- Low blood cell counts
- Low vitamin D or abnormal thyroid function needing supplementation
- Severe claustrophobia
- Poor cooperation or cognitive impairment
- Recent participation in another clinical trial
- Recent hospitalization
- Prisoners or institutionalized individuals
- Decisionally incapacitated individuals
- Any severe illness or condition deemed unsuitable by investigator
- Failure to complete required dietary intake assessments or extreme reported energy intake values
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Actively Recruiting
Research Team
S
Study Team
CONTACT
L
Lisa G Rider, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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