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临床试验/NCT04267653
NCT04267653已完成4 期

Lactoferrin Efficacy Versus Ferrous Sulfate in Treatment of Patients With Iron Deficiency Anemia

Assiut University1 个研究点 分布在 1 个国家目标入组 96 人开始时间: 2018年1月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
96
试验地点
1
主要终点
comparison of efficacy of lactoferrin versus ferrous sulfate tharapy in treatment of patients with iron deficiency anemia.

研究概览

简要总结

Lactoferrin (Lf) is a mammalian cationic iron binding glycoprotein belonging to the transferrin family which was discovered 70 years ago, and isolated simultaneously from human and bovine milks in 1960. It is widely distributed in all biological fluids and is also expressed by immune cells, which release it under stimulation by pathogens

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
Single (Participant)

入排标准

年龄范围
2 Years 至 15 Years(Child)
性别
All
接受健康志愿者

入选标准

  • all patients with iron deficiency anemia from 2 to 15 years old

排除标准

  • Anemia rather than iron deficiency anemia.
  • Family history of blood disease.
  • Patients with thalassemia trait.
  • Patients with chronic illness.

研究组 & 干预措施

ferrous sulfate

Active Comparator

Oral ferrous sulfate 3-6 mg/kg of elemental iron/day in divided doses

干预措施: Ferrous Sulfate (Drug)

lactoferrin

Active Comparator

Oral bovine lactoferrin (bfl) 100 mg once daily on empty stomach

干预措施: Lactoferrin Bovine (Drug)

combined

Active Comparator

combined therapy (both lactoferrin and ferrous sulfate)

干预措施: Lactoferrin Bovine (Drug)

combined

Active Comparator

combined therapy (both lactoferrin and ferrous sulfate)

干预措施: Ferrous Sulfate (Drug)

结局指标

主要结局

comparison of efficacy of lactoferrin versus ferrous sulfate tharapy in treatment of patients with iron deficiency anemia.

时间窗: 30 days

Complete blood count will be done before and after therapy to detect the effect of the therapy on serum hemoglobin(g/d)

Comparison of efficacy of lactoferrin versus ferrous sulfate tharapy in treatment of patients with iron deficiency anemia.

时间窗: 30 days

Total serum iron(ug/d) will be done before and after therapy to detect effect of the therapy on total serum iron level (ug/d)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ahmed Gaber Ahmed

pediatrician

Assiut University

研究点 (1)

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