%0 Journal Article %A Saunya Dover %A Samantha Stephens %A Jane E. Schneiderman %A Eleanor Pullenayegum %A Greg D. Wells %A Deborah M. Levy %A Jo-Anne Marcuz %A Kristi Whitney %A Andreas Schulze %A Ingrid Tein %A Brian M. Feldman %T The effect of creatine supplementation on muscle function in childhood myositis: A randomized, double-blind, placebo-controlled feasibility study %D 2020 %R 10.3899/jrheum.191375 %J The Journal of Rheumatology %P jrheum.191375 %X Objective To evaluate the feasibility of studying creatine in juvenile dermatomyositis (JDM). Secondary objectives were to determine the effect of creatine on muscle function and metabolism, aerobic capacity, fatigue, physical activity and quality of life, as well as its safety. Methods We conducted a 6-month double-blind, randomized, multiple-baseline design; patients were assigned to creatine or placebo. Feasibility was assessed using attended study visits, completed study procedures, and adherence. Muscle function, aerobic capacity and muscle strength were assessed with standardized exercise tests. Muscle metabolism was assessed using a 31-Phosphorus Magnetic Resonance Spectroscopy protocol. Fatigue, physical activity and quality of life were assessed by questionnaires. Statistical significance was estimated using a randomization (permutation) test. Changes in outcome measures taken at baseline and end-of-study were calculated using paired t tests. Results Median (range) adherence to the study drug was 88.5% (20.5-95.5%) and the proportion of subjects with 80% adherence or higher was 76.9%. There were no missed study visits. There were no statistically significant changes in muscle function, strength, aerobic capacity, disease activity, fatigue, physical activity or quality of life while subjects were on creatine compared to placebo. There were statistically significant adaptations in muscle metabolism (e.g., decrease in change in muscle pH following exercise, and decrease in Phosphate/Phosphocreatine ratio) at the end-of-study, compared to baseline. There were no significant adverse effects. Conclusion Creatine supplementation in children with JDM is feasible to study, and is safe and well-tolerated; it may lead to improvements in muscle metabolism. %U https://www.jrheum.org/content/jrheum/early/2020/07/27/jrheum.191375.full.pdf