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

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

The 50 most recent of 223 record versions are listed below. See every version on ClinicalTrials.gov ↗

  1. Minor Start date: Oct 19, 2026 to Oct 20, 2026
  2. Minor Start date: Oct 18, 2026 to Oct 19, 2026
  3. Minor Start date: Oct 14, 2026 to Oct 18, 2026
  4. Minor Start date: Oct 13, 2026 to Oct 14, 2026
  5. Minor Start date: Oct 12, 2026 to Oct 13, 2026
Show 27 earlier versionsHide 27 earlier versions
  1. Minor Start date: Oct 11, 2026 to Oct 12, 2026
  2. Minor Start date: Oct 8, 2026 to Oct 11, 2026
  3. Minor Start date: Oct 7, 2026 to Oct 8, 2026
  4. Minor Start date: Oct 6, 2026 to Oct 7, 2026
  5. Minor Start date: Oct 5, 2026 to Oct 6, 2026
  6. Minor Start date: Oct 4, 2026 to Oct 5, 2026
  7. Notable Primary endpoints: details revised at 1 of 1 entry Show 4 more changesShow less
    • Start date: Sep 20, 2026 to Oct 4, 2026
    • Eligibility criteria expanded, about 76 words
    • Secondary endpoints: details revised at 2 of 3 entries
    • Study description expanded, about 7 words
  8. Minor Start date: Sep 17, 2026 to Sep 20, 2026v211
  9. Minor Start date: Sep 16, 2026 to Sep 17, 2026v210
  10. Minor Start date: Sep 15, 2026 to Sep 16, 2026v209
  11. Minor Start date: Sep 14, 2026 to Sep 15, 2026v208
  12. Minor Start date: Sep 10, 2026 to Sep 14, 2026v207
  13. Minor Start date: Sep 9, 2026 to Sep 10, 2026v206
  14. Minor Start date: Sep 8, 2026 to Sep 9, 2026v205
  15. Minor Start date: Sep 7, 2026 to Sep 8, 2026v204
  16. Minor Start date: Sep 6, 2026 to Sep 7, 2026v203
  17. Minor Start date: Sep 3, 2026 to Sep 6, 2026v202
  18. Minor Start date: Sep 2, 2026 to Sep 3, 2026v201
  19. Minor Start date: Sep 1, 2026 to Sep 2, 2026v200
  20. Minor Start date: Aug 31, 2026 to Sep 1, 2026v199
  21. Minor Start date: Aug 30, 2026 to Aug 31, 2026v198
  22. Minor Start date: Aug 27, 2026 to Aug 30, 2026v197
  23. Minor Start date: Aug 26, 2026 to Aug 27, 2026v196
  24. Minor Start date: Aug 25, 2026 to Aug 26, 2026v195
  25. Minor Start date: Aug 24, 2026 to Aug 25, 2026v194
  26. Minor Start date: Aug 23, 2026 to Aug 24, 2026v193
  27. Minor Start date: Aug 20, 2026 to Aug 23, 2026v192
  1. Notable Enrollment increased: 300 → 3000 participants
    • Start date: Aug 19, 2026 to Aug 20, 2026
    v191
  2. Notable Enrollment target: 300 to 3000
    • Start date: Aug 18, 2026 to Aug 19, 2026
    v190
  3. Minor Start date: Aug 17, 2026 to Aug 18, 2026v189
  4. Minor Start date: Aug 16, 2026 to Aug 17, 2026v188
  5. Minor Start date: Aug 13, 2026 to Aug 16, 2026v187
  6. Minor Start date: Aug 12, 2026 to Aug 13, 2026v186
  7. Minor Start date: Aug 11, 2026 to Aug 12, 2026v185
  8. Minor Start date: Aug 10, 2026 to Aug 11, 2026v184
  9. Minor Start date: Aug 7, 2026 to Aug 10, 2026v183
  10. Minor Start date: Aug 6, 2026 to Aug 7, 2026v182
  11. Minor Start date: Aug 5, 2026 to Aug 6, 2026v181
  12. Minor Start date: Aug 4, 2026 to Aug 5, 2026v180
  13. Minor Start date: Aug 3, 2026 to Aug 4, 2026v179
  14. Minor Start date: Aug 2, 2026 to Aug 3, 2026v178
  15. Minor Start date: Jul 30, 2026 to Aug 2, 2026v177
  16. Minor Start date: Jul 29, 2026 to Jul 30, 2026v176
  17. Minor Start date: Jul 28, 2026 to Jul 29, 2026v175
  18. Minor Start date: Jul 27, 2026 to Jul 28, 2026v174
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07111065
Lead Sponsor National Institute of Environmental Health Sciences (NIEHS)
Conditions
(from sponsor)
Dermatomyositis (DM), Juvenile Dermatomyositis (JDM)
Related terms Dermatomyositis
Enrollment 3,000 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov