Iron Supplementation Outcome on Recurrent Upper Respiratory Tract Infections in 6-15 Years Old Egyptian School Children

Not Applicable

Completed

• Conditions: Recurrent Upper Respiratory Tract Infections; Iron Deficiency Anemia
• Interventions: Dietary Supplement: iron fumerate

• Registration Number: NCT02398968
• Lead Sponsor: Ain Shams University

Brief Summary

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 .

Detailed Description

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

Study Timeline

• Study Start: 2013-08
• Study First Submitted: 2015-02-19
• Study First Submitted QC: 2015-03-22
• Study First Posted: 2015-03-26
• Primary Completion: 2015-04
• Study Completion: 2016-05
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-27
• Last Update Posted: 2020-05-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

• 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.

Exclusion Criteria

• 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 .

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
B1:RURTI+no anemia+iron maintenance	iron fumerate	children with recurrent upper respiratory tract infection and no anemia receiving oral iron fumerate (1mg/kg/d) for 12 months
RURTI+IDA+iron therapy	iron fumerate	children with iron deficiency anemia on therapeutic iron fumerate therapy (6mg/kg/d) for 3 months, then maintained on iron fumerate supplementation(1mg/kg/d) for 12 months

Primary Outcome Measures

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

Trial Locations

Locations (1)

Pediatrics hospital Ain shams University; 🇪🇬 Cairo, Egypt