The Effect of Creatine Supplementation on Muscle Function in Childhood Myositis: A Randomized, Double-blind, Placebo-controlled Feasibility Study
Dover S, Stephens S, Schneiderman JE, Pullenayegum E, Wells GD, Levy DM, Marcuz JA, Whitney K, Schulze A, Tein I, Feldman BM
The Journal of rheumatology · 14 citas
Cómo se estudió
- Diseño
- Ensayo controlado aleatorizado (indexado por PubMed)
- Estudiado en
- Personas
- Resultado principal
- Marcadores de salud y funcionamiento
Quién lo pagó
- Financiación
- Financiación independiente
- Organización sin fines de lucro
- Rare Disease Foundation
- Organización sin fines de lucro
- Myositis Association
- Organización sin fines de lucro
- Cure JM Foundation
- Universidad u hospital
- University of Toronto
- Gobierno
- Canadian Institutes of Health Research
Según 5 financiadores declarados.
Publicación
- Publicado
- 2020-08-01 · J Rheumatol · vol. 48 · número 3 · págs. 434–441
- Editorial
- The Journal of Rheumatology Publishing Company Limited
- Citado
- 18 citas · más que el 79% de estudios similares · 1.2× el promedio de su campo
- Referencias
- 50 trabajos
- Acceso
- Lectura gratuita
- Áreas de investigación
- Inflammatory Myopathies and Dermatomyositis · Muscle metabolism and nutrition · Muscle Physiology and Disorders
- Palabras clave
- creatine supplementation, juvenile dermatomyositis, muscle function, muscle metabolism, phosphocreatine, muscle pH, cardiorespiratory fitness, fatigue, quality of life, physical activity, research feasibility, medication adherence, safety
- MeSH
- muscles, muscle, skeletal, humans, myositis, creatine, feasibility studies, double-blind method, quality of life, dietary supplements, child, muscle strength
11 autores
- Saunya Dover🇬🇧🇨🇦Great Ormond Street Hospital; Hospital for Sick Children
- Samantha Stephens🇬🇧🇨🇦Great Ormond Street Hospital; Hospital for Sick Children
- Jane E. Schneiderman🇨🇦University of Toronto; Hospital for Sick Children
- Eleanor Pullenayegum🇨🇦University of Toronto; Hospital for Sick Children
- Greg D. Wells🇬🇧🇨🇦Great Ormond Street Hospital; Hospital for Sick Children
- Deborah M. Levy🇨🇦University of Toronto; Hospital for Sick Children
- Jo-Anne Marcuz🇬🇧🇨🇦Great Ormond Street Hospital; Hospital for Sick Children
- Kristi Whitney🇬🇧🇨🇦Great Ormond Street Hospital; Hospital for Sick Children
- Andreas Schulze🇨🇦Hospital for Sick Children
- Ingrid Tein🇨🇦University of Toronto; Hospital for Sick Children
- Brian Michael Feldman🇨🇦University of Toronto; Hospital for Sick Children
Resumen
El texto original del estudio, en el idioma en que se publicó.
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 (QOL), 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 QOL 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 QOL while subjects were receiving 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.
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