the Effectiveness of Lactoferrin in Treatment of Iron Deficiency Anemia in Children With Chronic Tonsillitis
试验速览
- 阶段
- 4 期
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Increase in blood hemoglobin
研究概览
简要总结
the investigators will compare the response to iron deficiency anemia to lactoferrin plus ferrous poly maltose versus ferrous poly maltose in Children With Chronic Tonsillitis
详细描述
Iron deficiency is frequently present with chronic inflammatory disease.(1) Iron deficiency anemia results from decreased body's iron content due to blood loss, poor dietary iron intake, malabsorption, or increased iron requirement. Immune activation drives a diversion of iron to storage sites, particularly the mononuclear phagocytes system in liver and spleen leads to poor hemoglobinization and anemia. Iron deficiency and immune activation lead to disturbances of iron homeostasis.(2) this trial will compare the response to iron deficiency anemia to lactoferrin plus ferrous poly maltose versus ferrous poly maltose in Children With Chronic Tonsillitis
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 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •children 3-17 years old with chronic tonsillitis
排除标准
- •no other causes of Iron Deficiency Anemia
研究组 & 干预措施
lactoferrin+ferric hydroxide polymaltose
lactoferrin 100 mg /day plus ferric hydroxide polymaltose 6 mg /kilogram body wight for 3 months
干预措施: Lactoferrin (Drug)
lactoferrin+ferric hydroxide polymaltose
lactoferrin 100 mg /day plus ferric hydroxide polymaltose 6 mg /kilogram body wight for 3 months
干预措施: Ferric Hydroxide Polymaltose (Drug)
ferric hydroxide polymaltose
6 mg /kilogram body wight of ferric hydroxide poly maltose per day for 3 months
干预措施: Ferric Hydroxide Polymaltose (Drug)
结局指标
主要结局
Increase in blood hemoglobin
时间窗: 1,3 months
mean difference in hemoglobin level between pre treatment and post treatment. mean difference in hemoglobin level between pre treatment and post treatment.
Increase in serum ferritin
时间窗: 3 months
mean difference in ferritin level between pre treatment and post treatment.
次要结局
未报告次要终点
研究者
Shimaa Abdallah Ahmed
principal investigator
South Valley University