Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07111065
The ClinicalTrials.gov registry entry for NCT07111065 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 300 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Environmental Health Sciences (NIEHS), which has 145 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT07111065 reports 0 study locations.
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
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.