NCT07111065

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

Phase II, Randomized, Double-Blind, Placebo-Controlled Trial of Omega-3 Fatty Acid (O3FA) Supplementation for Adult and Juvenile Dermatomyositis (DM/JDM)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: National Institute of Environmental Health Sciences (NIEHS) · NIH
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Study Description: Multi-site, randomized, double-blind, placebo-controlled trial to evaluate the efficacy of O3FA supplementation on improving myositis disease activity, including muscle strength and function and other elements of disease activity, and quality of life in patients with mild to moderately active Dermatomyositis (DM)/Juvenile Dermatomyositis (JDM). Objectives: Primary Objective: -To examine the effect of O3FA supplementation on disease activity in a randomized, placebo-controlled trial in patients with mild to moderately active DM/JDM. Secondary Objectives: * To examine the effect of O3FA supplementation on DM/JDM disease activity. * To assess the safety and tolerability of O3FA supplementation in patients with DM/JDM. Exploratory Objectives: * To examine the effects of O3FA supplementation on measures of muscle strength and function, patient reported outcomes, vascular/endothelial function, mediators of inflammation and autoimmunity and other measures of DM/JDM disease activity * To examine effects of O3FAs on metabolic parameters and lipids * To examine the feasibility and compliance with a diet following the general healthy diet pattern. * To evaluate the effect of O3FAs and the study diet on stool microbial diversity. * To examine the effect of other lifestyle and environmental factors on the O3FA intervention response. Endpoints: Primary: Reduction in DM/JDM disease activity, as assessed by the American College of Rheumatology-European League Against Rheumatism (ACR-EULAR) Myositis Response Criteria Total Improvement Score (TIS), a composite of change in myositis core set activity measures, from Week 0 to Week 24. Secondary: Minimum improvement, as defined by ACR-EULAR myositis response criteria (i.e., improvement \>= 20 points in the TIS) and change in core set measures of myositis disease activity between week 0 and week 24 and between weeks 0 and 12. Frequency of adverse events (AE) in O3FA vs. Placebo group from week 0 to 24.

Conditions

• Dermatomyositis (DM)
• Juvenile Dermatomyositis (JDM)

Interventions

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

Timeline

• Start date: 2026-04-22
• Primary completion: 2030-11-03
• Completion: 2031-11-03
• First posted: 2025-08-08
• Last updated: 2026-04-17

Locations

1 site across 1 country: United States