NCT01217320Unknown不适用
Efficacy and Safety of Creatine Supplementation in Patients With Juvenile Systemic Lupus Erythematosus and Juvenile Dermatomyositis
适应症
干预措施
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- muscle strength
研究概览
简要总结
Creatine supplementation may improve strength, muscle mass, bone mass and muscle function in healthy and elderly people. The investigators speculate that creatine supplementation could have therapeutic effects in pediatric rheumatic (i.e., juvenile systemic lupus erythematosus and juvenile dermatomyositis) patients who usually present muscle weakness, muscle wasting and bone mass loss.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 6 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients diagnosed with lupus systemic erythematosus and juvenile dermatomyositis
- •physically inactive
- •stable pharmacological treatment
排除标准
- •macroalbuminuria
- •GFR < 30 mL/min/1.73m2
- •use of oral anticontraceptive agents
- •pregnancy
- •diabetes mellitus
- •hypothyroidism
研究组 & 干预措施
creatine supplementation
Experimental
will receive 5g/d of creatine monohydrate throughout the trial
干预措施: creatine (Dietary Supplement)
placebo
Placebo Comparator
will receive 5g/d of placebo (dextrose) throughout the trial
干预措施: placebo (dextrose) (Dietary Supplement)
结局指标
主要结局
muscle strength
时间窗: after six months
次要结局
- muscle function(after six months)
- kidney function parameters(after six months)
- quality of life(after six months)
研究者
Bruno Gualano
Principal Investigator
University of Sao Paulo
研究点 (2)
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