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NCT07111065 · ClinicalTrials.gov registry record · Phase 2
FAST for DM - Fatty Acid Supplementation Trial (FAST) for Dermatomyositis (DM)
A Phase 2 study, sponsored by National Institute of Environmental Health Sciences (NIEHS).
- Recruiting
- Registry status
- Phase 2
- Development phase
- 300
- Enrollment target
NCT07111065: Recruiting Phase 2 study, sponsored by National Institute of Environmental Health Sciences (NIEHS).
NCT07111065 is a Phase 2 study that is actively recruiting participants, run by National Institute of Environmental Health Sciences (NIEHS). The registered enrollment target is 300 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (126% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07111065, a Phase 2 study, is actively recruiting participants, sponsored by National Institute of Environmental Health Sciences (NIEHS).
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 300 participants
- Enrollment target
Study 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.
Primary Outcome
Assessed at 24 weeks for the treatment arm (O3FA) and the placebo arm.
Interventions
- DIETARY_SUPPLEMENT Placebo
- DIETARY_SUPPLEMENT FISH OIL 500MG OMEGA-3 SOFT GEL MINIS
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 300 participants |
| Start Date | 2026-07-15 |
| Est. Completion | 2031-11-03 |
| Phase | Phase 2 |
What NCT07111065 shows while recruiting
NCT07111065 is an interventional study that assigns participants to a tested intervention. The registered 300 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (126% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT07111065 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07111065 about?
NCT07111065 is a clinical study titled "FAST for DM - Fatty Acid Supplementation Trial (FAST) for Dermatomyositis (DM)". 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:...
What is the current status of trial NCT07111065?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 300 participants. The study started on 2026-07-15. Estimated completion is 2031-11-03.
What interventions are being tested in trial NCT07111065?
The interventions under investigation include: Placebo (DIETARY_SUPPLEMENT), FISH OIL 500MG OMEGA-3 SOFT GEL MINIS (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT07111065?
This trial is sponsored by National Institute of Environmental Health Sciences (NIEHS), which has 145 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07111065's enrollment target sits among peer trials
300 167th of 2000 higher than 1,813 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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