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临床试验/NCT04435574
NCT04435574已完成4 期

Comparison of Lactoferrin vs Traditional Iron Therapy for Treatment of Iron Deficiency Anemia in School-age Children.

Cairo University1 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5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
90
试验地点
1
主要终点
Hemoglobin

研究概览

简要总结

Anemia is a great public health problem affecting both developing and developed countries. Iron deficiency anemia represents about 50% of causes of anemia worldwide.

Lactoferrin fortified milk has a positive effect on Hb and iron status of infants.

the hypothesis of this study is "lactoferrin may have comparable efficacy to ferrous sulfate therapy with more tolerability and fewer side effects".

the research question of this study is whether oral lactoferrin is effective for treatment of iron deficiency anemia, compared to traditional ferrous sulfate therapy regarding hemoglobin rise and side effects and tolerability.

详细描述

Anemia is a great public health problem affecting both developing and developed countries. It is considered the most prevalent form of malnutrition in children and adolescents.

Supplementation with standard iron therapy is the main treatment of iron deficiency anemia.

There are two types of iron that are available: ferric and ferrous iron but ferrous iron better in absorption so it is more common in use.

Three types of ferrous iron are present: ferrous sulfate, ferrous fumarate, and ferrous gluconate but all forms have annoying gastrointestinal side effects including diarrhea, anorexia, heartburn, vomiting, nausea, abdominal cramps, upset stomach, and constipation making continuation on it for many weeks unpleasant for all even adults.

Studies have been performed to explore the effect of oral bovine lactoferrin on iron absorption on pregnant women. Many studies showed that oral bovine lactoferrin for pregnant women increased levels of hemoglobin, total serum iron, and ferritin and decreased the prevalence of iron deficiency anemia. although ferrous sulfate and lactoferrin both of them significantly improve the body's iron stores to the same extent, gastrointestinal side effects of lactoferrin were extremely lower than that of ferrous sulfate so oral bovine lactoferrin can replace iron forms in the treatment of iron deficiency anemia in pregnancy.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
6 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children with iron deficiency anemia.

排除标准

  • Malabsorption diseases as coeliac disease.
  • Diseases causing chronic blood loss as Meckel diverticulum.
  • Documented history of allergy to lactoferrin or ferrous sulfate.

研究组 & 干预措施

Group A

Experimental

group A is lactoferrin group, receiving 100mg sachet of lactoferrin once daily.

干预措施: Lactoferrin (Drug)

Group b

Active Comparator

group B is the ferrous sulfate group, receiving 6mg/kg/ day single dose of ferrous sulfate.

干预措施: Ferrous Sulfate (Drug)

结局指标

主要结局

Hemoglobin

时间窗: 8 weeks

hemoglobin%

Total serum iron

时间窗: 8 weeks

Total serum iron

次要结局

  • Side effects profile(4 weeks)

研究者

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

Saeed Salah Abduljalil Soliman

Lecturer of family medicine

Cairo University

研究点 (1)

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