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临床试验/NCT04014855
NCT04014855已完成4 期

The Effect of Lactoferrin Versus Iron Supplement in Treating Iron Deficiency Anemia and Helping Weight Loss in Obese School Age Children

Ain Shams University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2018年10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
50
试验地点
1
主要终点
iron deficiency anemia

研究概览

简要总结

The effect of lactoferrin versus iron supplement in treating iron deficiency anemia and helping weight loss in obese school age children

详细描述

Comparing iron versus lactoferrin as regard iron defiency anemia and weight loss in obese children

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
Double (Participant, Care Provider)

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 age will be between 6 -12 years old.
  • Presence of iron deficiency anemia, it will be diagnosed by
  • CBC >> Hemoglobin level concentration below 11.5 g/dl.
  • level of serum iron is below 30 µmol/l,
  • level of ferritin is below 15 µg/dl
  • Total iron binding capacity is more 480 µg/dlL.
  • children should be stable and free from chronic disease.
  • Body Mass index (BMI) should be ≥the 95th percentile for children and teens of the same age and sex.
  • there is not history of iron supplements in the 3 months before treatment.

排除标准

  • Father/mother refuses to participate in the study.
  • Hospitalized patient.
  • Non-anemic patient.
  • Patients receiving iron supplements 3 months before enrollment.
  • Patients with chronic diseases.
  • personal or family history of allergy to cow's milk or infant formula, eczema, moderate-to-severe allergic rhinitis or asthma, or milk intolerance.
  • severe anemia as Hemoglobin level concentration below 7 g/dl.
  • Exclusion Criteria:

研究组 & 干预措施

obese children 1

Active Comparator

iron supplementation

干预措施: Iron Supplement (Drug)

obese children 2

Active Comparator

lactoferrin supplementation

干预措施: Iron Supplement (Drug)

结局指标

主要结局

iron deficiency anemia

时间窗: 3 months

CBC and iron profile

次要结局

  • weight(3 months)

研究者

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

Marian girgis

lecturer of paediatrics

Ain Shams University

研究点 (1)

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