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临床试验/NCT02398968
NCT02398968已完成不适用

Effect of Iron Supplementation on Recurrent Upper Respiratory Tract Infections in Egyptian School Children: A One Year Prospective Study

Ain Shams University1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2013年8月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
1,000
试验地点
1
主要终点
effect of iron supplementation on recurrent upper respiratory tract infections measured by Canadian Acute Respiratory Illness and Flu Scale {CARIFS}

研究概览

简要总结

Recurrent upper respiratory infections ( RURTIs) are common in school aged children. An adequate iron status might reduce their prevalence. The aim of the study is to assess the percentage and type of RURTIs in Egyptian school children, assessing the percentage of iron deficiency anemia (IDA) and the effect of iron supplementation on the recurrence and severity of upper respiratory tract infections .

详细描述

This is a prospective interventional study in which 1000 Children (6-15 years) are recruited from two schools in urban Cairo; three months enrollment was done in early autumn ; students defined to have RURTIs were screened by Hemocue; if anemic (Hb < 11.5gm/dL),Complete blood picture and iron profile were done, they were enrolled into 2 groups: (A)children with IDA on oral iron fumerate therapy (6mg/kg/d) for 3 months, then maintained on oral iron (1mg/kg/d) for 12 months, and (B) Non anemic group; were randomly assigned in 1:1 ratio into: group (B1)children Received maintenance iron therapy for 12 months and group (B2) received placebo. Recurrence and severity of URTIs using (CARIFS score) throughout the study are recorded

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

入排标准

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

入选标准

  • Both genders were eligible, and we did not seek to balance the number of boys and girls.
  • Children completed the compulsory vaccination schedule of Egypt.

排除标准

  • Children with coexisting chronic disease such as renal, hepatic failure , IDDM, endocrine diseases, bronchial asthma and chronic diarrhea .
  • Patients with suspected immunodeficiency by presence of some of the warning symptoms or signs .

结局指标

主要结局

effect of iron supplementation on recurrent upper respiratory tract infections measured by Canadian Acute Respiratory Illness and Flu Scale {CARIFS}

时间窗: 15 months

Assessment of the upper respiratory tract infection incidence and severity throughout the study period will be done by a questionnaire including: Number of upper respiratory tract infection episodes per month with or without absenteeism from school, Total number of days sick with an upper respiratory tract infection ,and Canadian Acute Respiratory Illness and Flu Scale {CARIFS}

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

yasmin gamal el gendy

lecturer of pediatrics

Ain Shams University

研究点 (1)

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