The Effect of Creatine Supplementation on Muscle Function in Childhood Myositis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Muscle function
研究概览
简要总结
This project will bring together a multidisciplinary team of pediatric rheumatologists, neurologists, metabolic geneticists and exercise physiologists to determine the effect of creatine (CR) supplementation on muscle function and muscle metabolism in children with Dermatomyositis (DM). The investigators propose using well-established exercise testing techniques as well as new, powerful exercise imaging protocols in order to better delineate the effects of CR on muscle pathophysiology in a non-invasive way. Evidence from this study will provide information regarding the effect of creatine supplementation on muscle function in DM. Improvements in muscle function and fatigue through CR use may also contribute to an improvement in quality of life and have significant clinical implications for the treatment of children with DM.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 7 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ages 7 to 18 years
- •Diagnosis of probable JDM (onset <16 years) according to Bohan and Peter criteria
- •Subjects on a stable course of medication (unlikely to change over study treatment period as determined by the treating physician)
- •Minimum height of 132.5cm
排除标准
- •Subjects newly diagnosed with JDM within the previous 6 months
- •Subjects unable to cooperate with study procedures, or too weak to participate in the exercise testing
- •Subjects with impaired kidney function as determined from baseline visit screening lab values
- •Subjects who are currently pregnant or planning to become pregnant within the study period
- •Subjects who are shorter than 132.5cm
研究组 & 干预措施
Placebo
patients on this arm will be given a placebo glucose tablet supplement
干预措施: Glucose Tablet (Dietary Supplement)
Treatment
patients on this arm will be treated with creapure supplements
干预措施: Creapure (Dietary Supplement)
结局指标
主要结局
Muscle function
时间窗: 6 months
Will be determined by mean power output using a Wingate cycle ergometer protocol
次要结局
- Fatigue(6 months)
- Adherence(6 months)
- Muscle metabolism(6 months)
- Quality of life(6 months)
- Disease Activity(6 months)
- Muscle Strength(6 months)
研究者
Brian Feldman
Division Head, Rheumatology / Sr Scientist
The Hospital for Sick Children