FAST for DM - Fatty Acid Supplementation Trial (FAST) for Dermatomyositis (DM)

Part of paid clinical trials in Bethesda, Maryland.

Sponsor
National Institute of Environmental Health Sciences (NIEHS)
Study ID
NCT07111065
Phase
PHASE2
Status
Recruiting
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Conditions

  • Dermatomyositis (DM)
  • Juvenile Dermatomyositis (JDM)

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

  • FISH OIL 500MG OMEGA-3 SOFT GEL MINIS — DIETARY_SUPPLEMENT
    Translucent, light yellow, oblong soft gelatin capsule containing a straw to amber light liquid.
  • Placebo — DIETARY_SUPPLEMENT
    Placebo capsules look identical to fish oil but contain corn oil, complemented by healthy diet

Study Details

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.

Key Dates

Start date
Jun 16, 2026
Status verified
Apr 2026
Primary completion
Nov 3, 2030
Completion
Nov 3, 2031

Study Design

Enrollment
300 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Omega-3 Fatty Acid Fish Oil Dietary Supplement and General Healthy Diet Pattern
    Fish oil supplement and healthy diet
  • Placebo Comparator: Placebo and General Healthy Diet Pattern
    Placebo capsules look identical to fish oil but contain corn oil, complemented by healthy diet

Primary Outcome Measure

Reduction in DM/JDM disease activity, as assessed by the ACR-EULAR Myositis Response Criteria Total Improvement Score, a composite assessment of change in myositis core set activity measures, between the O3FA vs. placebo groups. [ Time Frame: From Week 0 to Week 24 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
National Institutes of Health Clinical CenterBethesdaMaryland20892
NIH Clinical Center Office of Patient Recruitment (OPR)
[email protected]
800-411-1222

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By research site
National Institutes of Health Clinical Center· Bethesda, MD

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