Pilot Pragmatic Clinical Trial of Oral Iron Therapy in Children With Chronic Kidney Disease
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Change in muscle strength
研究概览
简要总结
This is a pilot clinical trial of oral iron therapy in children with chronic kidney disease (CKD) and mild anemia. Eligible children will be randomized into a standard of care (iron sulfate) arm vs. no iron therapy arm for 3 months. The outcomes will include muscle strength, physical activity, and changes in eating behavior, which will be measured at enrollment and at the end of the study period.
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
- None
入排标准
- 年龄范围
- 1 Year 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Oral Iron therapy
Participant will receive oral iron therapy.
干预措施: Ferrous Sulfate (Drug)
结局指标
主要结局
Change in muscle strength
时间窗: 0 and 3 months
Hand-grip strength measured by a dynamometer
Change in the percentage of transferrin saturation in the participants' blood
时间窗: 0 and 3 months
Transferrin saturation is a medical laboratory value, measured as a percentage. It is the value of serum iron concentration divided by the total iron-binding capacity. For instance, a value of 15% means that 15% of iron-binding sites of transferrin are being occupied by iron. Blood will be collected with the venopuncture used for clinically indicated blood tests at routine clinic visits
次要结局
- Change in sedentary time(0 and 3 months)
- Change in the percent of skeletal muscle mass(0 and 3 months)
- Change in eating behavior(0 and 3 months)
- Change in quality of life: PROMIS(0 and 3 months)