FAST for DM - Fatty Acid Supplementation Trial (FAST) for Dermatomyositis (DM)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-60
SponsorNational Institute of Environmental Health Sciences (NIEHS)
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults 18-60 years of age with probable or definite EULAR ACR Myositis Classification Criteria 2017 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.
Disqualifiers
Polymyositis; inclusion body myositis; cancer-associated myositis, defined as the diagnosis of myositis within 3 years of the diagnosis of cancer, except basal or squamous cell skin cancer or carcinoma in situ of the cervix if at least 5 years since excision.
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.
Trial design
Design model
Parallel
Treatments tested in this trial
FISH OIL 500MG OMEGA-3 SOFT GEL MINIS
Dietary supplementTranslucent, light yellow, oblong soft gelatin capsule containing a straw to amber light liquid.
Placebo
Dietary supplementPlacebo capsules look identical to fish oil but contain corn oil, complemented by healthy diet
Treatment groups
3,000 Participants
are divided into 2 treatment groupsGroup A: Omega-3 Fatty Acid Fish Oil Dietary Supplement and General Healthy Diet PatternActive comparator 1 intervention
Group B: Placebo and General Healthy Diet PatternPlacebo comparator 1 intervention
Trial outcomes
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.
Time frame
From Week 0 to Week 24Secondary outcomes
1
Meeting minimum clinical improvement in disease activity in O3FA and placebo groups
Minimum clinical improvement defined by ACR EULAR myositis response criteria: improvement of \>= 20 points in the Total Improvement Score (TIS) between the O3FA vs. placebo groups at Week 24
Time frame
From Week 0 to Week 242
The effects of O3FA on DM/JDM disease activity
Change in myositis disease activity as assessed by specific core set disease activity measures between the O3FA vs. placebo groups
Time frame
From Week 0 to Week 243
Safety and Tolerability
Incidence of adverse events by NCI CTC Adverse Event assessments between the O3FA vs. placebo groups.
Time frame
From Week 0 to Week 24Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov