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临床试验/NCT03940430
NCT03940430已完成2 期

Lactoferrin Versus Ferrous Sulfate in Management of Iron Deficiency Anemia Among Female Medical Ain Shams Students

yasmin gamal el gendy1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2018年9月10日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
90
试验地点
1
主要终点
Management of iron deficiency anemia incidence by using lab measures include iron profile

研究概览

简要总结

This study aims to compare the efficacy of lactoferrin versus iron supplementation versus two combined supplementation on iron deficiency anemia in female medical Ain Shams students by using iron profile.

详细描述

Iron, an essential element for cell growth and proliferation, is a component of fundamental processes such as DNA replication and energy production. However, iron can also be toxic when present in excess for its capacity to donate electrons to oxygen, thus causing the generation of reactive oxygen species (ROS), such as superoxide anions and hydroxyl radicals

Prevalence of iron deficiency anemia is roughly 38% of pregnant women, 29% of non-pregnant women and 29% of all women of reproductive age have anemia globally

Human lactoferrin (hLf), an 80-kDa multifunctional iron-binding cationic glycoprotein, is constitutively secreted by exocrine glands and by neutrophils during inflammation. hLf is recognized as a key element in the host immune defense system

Bovine Lf (bLf), which shares high sequence homology with the human protein, is also a multifunctional glycoprotein with identical antibacterial, antifungal, antiviral, antiparasitic, anti-inflammatory, and immunomodulatory activities of hLf Lactoferrin is synthesized by exocrine glands and neutrophils under conditions of inflammation and at site of infection through its iron binding and formation of reactive oxygen species physiological transport of iron from tissue to circulation, thus curing iron deficiency and iron deficiency anemia

A study done for pregnant women showed an increase of total serum iron in all bovin lactoferrin treated women.

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 (Outcomes Assessor)

入排标准

年龄范围
19 Years 至 29 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • female student with iron deficiency anemia

排除标准

  • clinical diagnosis of chronic disease as DM, Malabsorption disease Celiac, blood disease as thalassemia, or haemoglobinopathy
  • Intervention:
  • Study participants will be divided into 3 groups; Group 1: 35 participants will be supplemented with iron salt 324 mg (66 mg of elemental iron) orally three time per day before meal for one month Group 2: 35 participants will be supplemented with LF sachet 100 mg twice per day before meal for period of one month.
  • Group 3: 35 participants will be supplemented with combined iron salt 324 mg (66 mg of elemental iron) orally three time per day before meal for one month, and LF sachet 100 mg twice per day before meal for period of one month.

研究组 & 干预措施

Lactoferrin in iron deficiency anemia

Active Comparator

lactoferrin ( pravotin) 100mg twice daily

干预措施: Lactoferrin (Drug)

Ferrous sulfate in iron deficiency anemia

Active Comparator

ferrous sulphate (hemojet)

干预措施: Ferrous sulfate (Drug)

Lactoferrin and ferrous sulfate in iron deficiency anemia

Active Comparator

Lactoferrin 100 mg twice daily and ferrous sulfate

干预措施: Lactoferrin (Drug)

Lactoferrin and ferrous sulfate in iron deficiency anemia

Active Comparator

Lactoferrin 100 mg twice daily and ferrous sulfate

干预措施: Ferrous sulfate (Drug)

结局指标

主要结局

Management of iron deficiency anemia incidence by using lab measures include iron profile

时间窗: One month

Management of iron deficiency anemia

次要结局

未报告次要终点

研究者

发起方
yasmin gamal el gendy
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

yasmin gamal el gendy

Yasmin gamel elgendy clinical professor

Ain Shams University

研究点 (1)

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