Omega-3 Supplements for Dermatomyositis
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine if omega-3 supplements from fish oil, combined with a healthy diet, can improve symptoms for individuals with dermatomyositis (DM) or juvenile dermatomyositis (JDM). DM is a rare autoimmune condition that causes muscle weakness and skin rashes, and researchers are investigating the impact of diet and lifestyle on it. Participants will receive either fish oil capsules or a placebo while maintaining a healthy diet. Those with DM or JDM symptoms, such as muscle weakness or skin rashes, who can commit to regular study visits and online check-ins, may be suitable candidates. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of people.
Do I need to stop my current medications to join the trial?
Yes, you may need to stop certain medications to join the trial. If you are taking prednisone, methotrexate, or other immunosuppressive drugs, they must be at a stable dose for a specific period before the trial. If you need to stop these or other medications, there are specific 'washout' periods (time without taking certain medications) required before you can participate.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that fish oil, rich in omega-3 fatty acids, is generally safe for most people. Consuming up to 3 grams daily by mouth is considered safe. It can lower triglyceride levels, a type of fat in the blood, potentially reducing the risk of certain heart problems, especially for those with low omega-3 intake.
Additionally, omega-3 fatty acids may benefit autoimmune diseases like psoriasis and type 1 diabetes, which share some similarities with dermatomyositis. This suggests they might help manage symptoms for individuals with these conditions.
However, consuming more than 3 grams daily could increase the risk of bleeding or other side effects. Following dosing guidelines carefully is important. Consulting a healthcare provider before starting new supplements is always recommended.12345Why do researchers think this study treatment might be promising for dermatomyositis?
Researchers are excited about using omega-3 fish oil supplements for treating dermatomyositis because these supplements take a unique approach compared to the current treatments. Unlike traditional therapies, which often involve corticosteroids or immunosuppressants to manage inflammation, omega-3 fatty acids are believed to reduce inflammation naturally by altering the body's production of inflammatory molecules. This could potentially lead to fewer side effects and a more natural method of managing symptoms. Additionally, incorporating dietary guidelines alongside the supplement may offer a holistic approach to improving the overall health of patients with dermatomyositis.
What evidence suggests that omega-3 supplements might be an effective treatment for dermatomyositis?
Research shows that omega-3 fatty acids in fish oil can reduce inflammation, which might benefit people with dermatomyositis (DM), a condition causing muscle inflammation. One study on skin disorders found that fish oil lowered inflammation levels over six months. Other research suggests that omega-3 supplements can aid certain skin conditions, which might also apply to DM. In this trial, participants will receive either an omega-3 fatty acid fish oil dietary supplement or a placebo. Although more studies are needed, early results are promising for using fish oil to manage DM symptoms.13678
Who Is on the Research Team?
Lisa G Rider, M.D.
Principal Investigator
National Institute of Environmental Health Sciences (NIEHS)
Are You a Good Fit for This Trial?
Adults aged 18-60 living in the US, who can read English and access the internet to complete questionnaires. They should be able to stay at the Clinical Center for up to 5 days for visits and comply with dietary guidelines.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants take omega-3 fatty acid supplements or placebo for up to 6 months, with dietary coaching and virtual check-ins
Follow-up
Participants are monitored for safety and effectiveness after treatment
Open-label extension (optional)
Participants may opt to continue receiving fish oil supplements for an additional 12 weeks
What Are the Treatments Tested in This Trial?
Interventions
- Fish Oil
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Institute of Environmental Health Sciences (NIEHS)
Lead Sponsor