Comparative Clinical Study to Evaluate the Efficacy and Safety of Oral Liposomal Iron, Oral Iron Supported Lactoferrin and IV Iron Dextran in Children With Chronic Kidney Disease
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 90
- 主要终点
- Hemoglobin measure
研究概览
简要总结
This is a randomized, parallel study that will be conducted on pediatric patients with CKD.
详细描述
The study will be conducted on 90 pediatric patients with CKD who will be divided into 3 groups: Group l: 30 pediatric patients who will receive oral liposomal iron 30 mg/day for 12 weeks. Group 2: 30 pediatric patients who will receive oral iron supported iron 1 mg+ lactoferrin 100 mg/day for 12 weeks. Group 3: 30 pediatric patients who will receive IV iron dextran 50 mg/3 times weekly for 12 weeks.
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
- 3 Months 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A) Pediatrics ≤18 year old male and female patients. B) Pediatrics with CKD stages 3-5.
排除标准
- •A) CKD patients' ≥18 year old. B) Active bleeding C) Malignancy D) Anemia due to any disease other than CKD E) Blood Transfusions
研究组 & 干预措施
Liposomal iron
30 pediatric patients who will receive oral liposomal iron (Novoferr) 30 mg/day for 12 weeks.
干预措施: Ferric Pyrophosphate Liposomal (Drug)
Iron supported Lactoferrin
30 pediatric patients who will receive oral iron supported Lactoferrin iron (Provan) 100 mg/day for 12 weeks.
干预措施: Lactoferrin (Drug)
Iv iron dextran
30 pediatric patients who will receive IV iron dextran 50 mg/3 times weekly for 12 weeks.
干预措施: Iron Dextran Injection (Drug)
结局指标
主要结局
Hemoglobin measure
时间窗: 3 months
Measure oxygen in blood by measuring hemoglobin by coloremetric assay
次要结局
- Biomarkers measure(3 months)
研究者
Mai Salah El-Din
Critical care clinical pharmacist
Menoufia University