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Clinical Trial: Fatty Acid Supplementation Trial for Dermatomyositis (FAST for DM)

Multi-site, randomized, double-blind, placebo-controlled trial to evaluate the efficacy of O3FA supplementation on improving myositis disease activity, including muscle strength and function and other elements of disease activity, and quality of life in patients with mild to moderately active Dermatomyositis (DM)/Juvenile Dermatomyositis (JDM).

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Condition

Dermatomyositis (DM) or Juvenile Dermatomyositis (JDM)

Overview

This clinical trial is being conducted to evaluate the effect of omega-3 fatty acid (O3FA) supplementation (fish oil) on myositis disease activity and quality of life in adult patients with mild to moderately active Dermatomyositis (DM)/Juvenile Dermatomyositis (JDM). The study will also examine the results of following a healthy diet pattern with O3FA supplements or placebo capsules in adult patients with DM/JDM. Researchers believe that fish oil may decrease dermatomyositis disease activity and improve muscle strength.

Participation Eligibility

Inclusion criteria:

  • Subjects must be adults 18-60 years old
  • A diagnosis of juvenile or adult dermatomyositis that is currently active
  • Willingness to take study supplement twice a day for 24 weeks
  • Willingness to adhere to the study diet and undergo dietary coaching
  • Ability to read English and access the internet for completing questionnaires and viewing diet coaching materials and videos.
  • Participate in 5 study visits at the NIH Clinical Center in Bethesda, Maryland

Exclusion criteria:

  • Are pregnant or breastfeeding
  • Have certain known food allergies
  • Are using O3FAs or taking EPA/DHA in any form in the past 6 months
  • Have other forms of myositis such as: polymyositis, inclusion body myositis, and cancer-associated myositis
  • Other eligibility criteria are available on ClinicalTrials.gov https://clinicaltrials.gov/study/NCT07111065

For More Information

To learn more about the study, contact 301-496-0208 or visit https://joinastudy.niehs.nih.gov/studies/fast-dermatomyositis. You may also learn more about this study by reviewing an online consent and completing a pre-screening questionnaire: https://redcap.link/fastfordm_prescreening.

Contact Information

This investigational study is being conducted by Lisa Rider, M.D., and Adam Schiffenbauer, M.D., at the Environmental Autoimmunity Group (EAG), National Institute of Environmental Health Sciences (NIEHS), National Institutes of Health Clinical Center, 10 Center Drive, Building 10, Bethesda, Maryland

NIH NIEHS