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

NCT07111065 | Recruiting Phase 2

• 2 other identifiers: 10001790001790-E
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Dermatomyositis (DM); Juvenile Dermatomyositis (JDM)

Keywords

Fish oil supplements; Omega-3 Fatty Acid; Clinical Trial; Online questionnaires; Diet Study

Outcome Measures

Primary Outcomes (1)

• 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.

  Assessed at 24 weeks for the treatment arm (O3FA) and the placebo arm.

  From Week 0 to Week 24

Secondary Outcomes (3)

• Meeting minimum clinical improvement in disease activity in O3FA and placebo groups

  From Week 0 to Week 24

• The effects of O3FA on DM/JDM disease activity

  From Week 0 to Week 24

• Safety and Tolerability

  From Week 0 to Week 24

Study Arms (2)

Omega-3 Fatty Acid Fish Oil Dietary Supplement and General Healthy Diet Pattern

ACTIVE COMPARATOR

Fish oil supplement and healthy diet

Dietary Supplement: FISH OIL 500MG OMEGA-3 SOFT GEL MINIS

Placebo and General Healthy Diet Pattern

PLACEBO COMPARATOR

Placebo capsules look identical to fish oil but contain corn oil, complemented by healthy diet

Dietary Supplement: Placebo

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.

Omega-3 Fatty Acid Fish Oil Dietary Supplement and General Healthy Diet Pattern

Placebo DIETARY_SUPPLEMENT

Placebo capsules look identical to fish oil but contain corn oil, complemented by healthy diet

Placebo and General Healthy Diet Pattern

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• In order to be eligible to participate in this study, an individual must meet all of the following criteria:
• Adults 18-60 years of age with probable or definite EULAR-ACR criteria for adult or juvenile dermatomyositis (DM, JDM).
• Willingness to adhere to the general healthy diet pattern regimen, undergo dietary coaching on weekly to biweekly basis (10 sessions), and to complete online random reporting of dietary intake over a 6-month period.
• Ability and willingness to comply with taking 4 study pills twice a day for 6 months.
• Ability and willingness to wear ActiGraph device at home for 7 continuous days, twice in the study.
• Willingness and ability to complete and consent to study testing, including blood, stool, and urine samples, and imaging studies.
• Ability and willingness to complete a total of 5 study visits (screening, weeks -6, 0, 12, 24) onsite at NIH Clinical Center in Bethesda, Maryland.
• Has the ability/transportation methods to attend on-site visits. Willing to pay for travel and out-of-pocket expenses.
• Own or have reliable access to a computer, laptop or smart phone device (iPhone or Android) with internet access, and an active email address, to complete study consent form, online questionnaires, telehealth visits, and review online dietary education materials and videos.
• Ambulatory
• Must live within the United States.
• Must be proficient in the English language and complete questionnaires in English (forms validated in English). Ability and willingness to complete forms online.
• Moderately active DM/JDM defined by:
• MD global VAS with a \>= 2.0 cm on a 10 cm scale and maximum value of 7.0 cm, and
• At least 2 of the following criteria:

You may not qualify if:

• An individual who meets any of the following criteria will be excluded from participation in this study:
• Myositis in overlap with another autoimmune disease will be excluded under the following conditions:
• i. Myositis overlapping with another autoimmune disease that precludes accurate assessment of treatment response (e.g., difficulty assessing muscle strength in a patient with scleroderma and associated myositis).
• ii. Myositis overlapping with inflammatory bowel disease, including Crohn s disease, ulcerative colitis, or celiac disease.
• iii. Myositis overlapping with autoimmune thyroid disease (e.g., Hashimoto s disease or Graves disease), unless the thyroid disease is
• stable and well controlled with no changes in thyroid-related medications for at least 3 months prior to enrollment, in which case the
• patient may be included.
• Drug- or toxin-induced myositis, including known HMG-CoA reductase autoantibody-positive necrotizing myopathy following statin use.
• Moderate to severely active myositis that would require initiation of another immunosuppressive treatment.
• Joint disease, severe calcinosis, or other musculoskeletal condition, which precludes the ability to assess/quantitate muscle strength and function.
• Concomitant illness that would prevent adequate patient assessment or in the investigators opinion pose an added risk for study participants. The investigator may consider further evaluation or consultation if clinically indicated prior to study enrollment:
• Recurrent or chronic infections, including HIV, hepatitis B and C, Epstein Barr virus, active coronavirus infection, active or recurrent gastrointestinal infection (including Helicobacter pylori), active or recurrent skin infections with calcinosis.
• Disorders that would preclude accurate assessment of neuromuscular function.
• Severe swallowing dysfunction with inability to swallow pills.
• Patients with generalized lipodystrophy.

Sponsors & Collaborators

• National Institute of Environmental Health Sciences (NIEHS): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

RECRUITING

Related Publications (6)

• Rider LG, Aggarwal R, Machado PM, Hogrel JY, Reed AM, Christopher-Stine L, Ruperto N. Update on outcome assessment in myositis. Nat Rev Rheumatol. 2018 May;14(5):303-318. doi: 10.1038/nrrheum.2018.33. Epub 2018 Apr 12.

  PMID: 29651119 BACKGROUND

• Ward JM, Ambatipudi M, O'Hanlon TP, Smith MA, de Los Reyes M, Schiffenbauer A, Rahman S, Zerrouki K, Miller FW, Sanjuan MA, Li JL, Casey KA, Rider LG. Shared and Distinctive Transcriptomic and Proteomic Pathways in Adult and Juvenile Dermatomyositis. Arthritis Rheumatol. 2023 Nov;75(11):2014-2026. doi: 10.1002/art.42615. Epub 2023 Aug 13.

  PMID: 37229703 BACKGROUND

• Saygin D, Kim H, Douglas C, Erman B, Wilkerson J, McGrath JA, Oddis CV, Lundberg IE, Amato AA, Garcia-De La Torre I, Chinoy H, Fiorentino D, Chung L, Song YW, Miller FW, Ruperto N, Vencovsky J, Aggarwal R, Rider LG; International Myositis Assessment and Clinical Studies Group (IMACS). Performance of the 2016 ACR-EULAR Myositis Response Criteria in adult dermatomyositis/polymyositis therapeutic trials and consensus profiles. Rheumatology (Oxford). 2023 Nov 2;62(11):3672-3679. doi: 10.1093/rheumatology/kead110.

  PMID: 36929923 BACKGROUND

• Tedeschi SK, Costenbader KH. Is There a Role for Diet in the Therapy of Rheumatoid Arthritis? Curr Rheumatol Rep. 2016 May;18(5):23. doi: 10.1007/s11926-016-0575-y.

  PMID: 27032786 BACKGROUND

• Gioxari A, Kaliora AC, Marantidou F, Panagiotakos DP. Intake of omega-3 polyunsaturated fatty acids in patients with rheumatoid arthritis: A systematic review and meta-analysis. Nutrition. 2018 Jan;45:114-124.e4. doi: 10.1016/j.nut.2017.06.023. Epub 2017 Jul 8.

  PMID: 28965775 BACKGROUND

• Ramessar N, Borad A, Schlesinger N. The effect of Omega-3 fatty acid supplementation in systemic lupus erythematosus patients: A systematic review. Lupus. 2022 Mar;31(3):287-296. doi: 10.1177/09612033211067985. Epub 2022 Jan 13.

  PMID: 35023407 BACKGROUND

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Dermatomyositis

Interventions

Fish Oils

Condition Hierarchy (Ancestors)

Polymyositis; Myositis; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Intervention Hierarchy (Ancestors)

Oils; Lipids

Study Officials

• Lisa G Rider, M.D.

  National Institute of Environmental Health Sciences (NIEHS)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Team

CONTACT

(301) 496-6664; fastdmsupport@nih.gov

Lisa G Rider, M.D.

CONTACT

(301) 451-6272; riderl@mail.nih.gov

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2025
• First Posted: August 8, 2025
• Study Start (Estimated): May 11, 2026
• Primary Completion (Estimated): November 3, 2030
• Study Completion (Estimated): November 3, 2031
• Last Updated: May 6, 2026

Record last verified: 2026-04-20

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)