Phase II, Randomized, Double-Blind, Placebo-Controlled Trial of Omega-3 Fatty Acid (O3FA) Supplementation for Adult and Juvenile Dermatomyositis (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.
∙ 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:
• Patient global activity \>= 2 cm out of 10 cm visual analog scale (VAS).
∙ MMT-8 score of \<=138 out of 150.
∙ Health Assessment Questionnaire disability index with a minimum value of \>= 0.50 out of 3.0
∙ Elevation of at least one of the muscle enzymes (which includes creatine kinase (CK), aldolase, lactate dehydrogenase (LDH), ALT and AST) at a minimum level of 1.3X the upper limit of normal.
∙ Global Extramuscular disease activity score with a minimum value of \>= 1.0 cm on a 10 cm VAS scale (this measure is the physician s composite evaluation and is based on assessments of activity scores on the constitutional, cutaneous, skeletal, gastrointestinal, pulmonary and cardiac scales of the Myositis Disease Activity Assessment Tool (MDAAT).
• Physician global damage and muscle damage both \<= 5.0 cm/10 cm VAS
• If receiving prednisone and methotrexate, the dose must be stable for at least 4 weeks prior to the Week 6 visit, and daily prednisone \<= 20 mg/day.
• Background therapy with other non-corticosteroid immunosuppressive agent, if required, must be at a stable dose for at least 6 weeks prior to the Week 6 visit, except with IVIG regimen should be stable 90 days prior to the Week 6 visit and for rituximab, stable regimen for 4 months prior to Week 6.
• If an immunosuppressive agent was discontinued prior to the screening visit, then there must be a washout period before week -6 visit:
‣ 4-week washout for prednisone, methotrexate, and IV methylprednisolone (IV pulse therapy)
⁃ 8-week washout for other immunosuppressive drugs, including azathioprine, mycophenolate mofetil, leflunomide, tacrolimus, cyclosporine, cyclophosphamide, colchicine, and hydroxychloroquine
⁃ 8-week washout for IVIG
⁃ For discontinuation of biologic or targeted drug therapies or dietary supplements, a washout prior to visit 1 (week 6) is required of 4 terminal half-lives.
• Half-lives of most common biologics and targeted drug therapies used in the treatment of DM/JDM:
‣ Etanercept Half-life 70 hours, Waiting period before enrollment (4 Half-lives) 12 days
⁃ Adalimumab, Half-life, 14 days, Waiting period before enrollment (4 Half-lives) 60 days
⁃ Rituximab, Half-life 32 days, Waiting period before enrollment (4 Half-lives) 130 days
⁃ Infliximab, Half-life 9 days, Waiting period before enrollment (4 Half-lives) 36 days
⁃ Abatacept, Half-life 17 days, Waiting period before enrollment (4 Half-lives) 68 days
⁃ Anakinra, Half-life 6 hours, Waiting period before enrollment (4 Half-lives) 1 day
⁃ Tofacitinib, Half-life 3 hours, Waiting period before enrollment (4 Half-lives) 1 day
⁃ Baricitinib, Half-life 12hours, Waiting period before enrollment (4 Half-lives) 2 days
• Negative pregnancy test (urine or blood sample) if born female.
• Body Mass Index (BMI) \> 18 and \<= 35 kg/m\^2
• Fish intake of less than 2 servings per week on average for the past 3 months.
• Intake of meat products (beef, lamb, pork, venison, rabbit, cow s milk or dairy products) within 2 months of screening visit and of week 0 and have no reaction (no shortness of breath, hives, rash, or diarrhea) within 6 hours of ingestion of these meat products.