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

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

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 .

Study Overview

• Status: Completed
• Conditions: Iron Deficiency Anemia; Recurrent Upper Respiratory Tract Infections
• Intervention / Treatment: Dietary supplement: iron fumerate

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 Type: Interventional
• Enrollment (Actual): 1000
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Pediatrics hospital Ain shams University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 15 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: RURTI+IDA+iron therapy; 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	Dietary supplement: iron fumerate; iron fumerate supplementation (6mg/kg/d) for arm 1 iron fumerate supplementation (1mg/kg/d) for arm 2
Active Comparator: B1:RURTI+no anemia+iron maintenance; children with recurrent upper respiratory tract infection and no anemia receiving oral iron fumerate (1mg/kg/d) for 12 months	Dietary supplement: iron fumerate; iron fumerate supplementation (6mg/kg/d) for arm 1 iron fumerate supplementation (1mg/kg/d) for arm 2
No Intervention: B2:RURTI+no anemia; children with recurrent upper respiratory tract infection and no anemia followed up for 12 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
effect of iron supplementation on recurrent upper respiratory tract infections measured by Canadian Acute Respiratory Illness and Flu Scale {CARIFS}	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}	15 months

Collaborators and Investigators

• Sponsor: Ain Shams University
• Investigators: Study Director: Mohsen S Elalfy, professor, Ain Shams University; Study Chair: Ehab K Emam, professor, Ain Shams University; Study Chair: Khaled M Abd-al aziz, professor, Ain Shams University; Principal Investigator: Yasmin G El gendy, lecturer, Ain Shams University; Study Chair: Mohamed T Hamza, lecturer, Ain Shams University; Principal Investigator: marian g rizk, ass lect, Ain Shams University

Study record dates

Study Major Dates

• Study Start: August 1, 2013
• Primary Completion (Actual): April 1, 2015
• Study Completion (Actual): May 1, 2016

Study Registration Dates

• First Submitted: February 19, 2015
• First Submitted That Met QC Criteria: March 22, 2015
• First Posted (Estimate): March 26, 2015

Study Record Updates

• Last Update Posted (Actual): May 28, 2020
• Last Update Submitted That Met QC Criteria: May 27, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: children; Iron; RURTIs; CARIFS
• Additional Relevant MeSH Terms: Pathologic Processes; Metabolic Diseases; Respiratory Tract Diseases; Disease Attributes; Hematologic Diseases; Anemia, Hypochromic; Anemia; Iron Metabolism Disorders; Infections; Communicable Diseases; Anemia, Iron-Deficiency; Recurrence; Respiratory Tract Infections
• Other Study ID Numbers: 1-elalfy