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

Primary Purpose

Recurrent Upper Respiratory Tract Infections, Iron Deficiency Anemia

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
iron fumerate
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Recurrent Upper Respiratory Tract Infections focused on measuring Iron, RURTIs, CARIFS, children

Eligibility Criteria

6 Years - 15 Years (Child)All SexesAccepts Healthy Volunteers

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 .

Sites / Locations

  • Pediatrics hospital Ain shams University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

No Intervention

Arm Label

RURTI+IDA+iron therapy

B1:RURTI+no anemia+iron maintenance

B2:RURTI+no anemia

Arm Description

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

children with recurrent upper respiratory tract infection and no anemia receiving oral iron fumerate (1mg/kg/d) for 12 months

children with recurrent upper respiratory tract infection and no anemia followed up for 12 months

Outcomes

Primary Outcome Measures

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}

Secondary Outcome Measures

Full Information

First Posted
February 19, 2015
Last Updated
May 27, 2020
Sponsor
Ain Shams University
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1. Study Identification

Unique Protocol Identification Number
NCT02398968
Brief Title
Iron Supplementation Outcome on Recurrent Upper Respiratory Tract Infections in 6-15 Years Old Egyptian School Children
Official Title
Effect of Iron Supplementation on Recurrent Upper Respiratory Tract Infections in Egyptian School Children: A One Year Prospective Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
August 2013 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
May 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Upper Respiratory Tract Infections, Iron Deficiency Anemia
Keywords
Iron, RURTIs, CARIFS, children

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
1000 (Actual)

8. Arms, Groups, and Interventions

Arm Title
RURTI+IDA+iron therapy
Arm Type
Active Comparator
Arm Description
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
Arm Title
B1:RURTI+no anemia+iron maintenance
Arm Type
Active Comparator
Arm Description
children with recurrent upper respiratory tract infection and no anemia receiving oral iron fumerate (1mg/kg/d) for 12 months
Arm Title
B2:RURTI+no anemia
Arm Type
No Intervention
Arm Description
children with recurrent upper respiratory tract infection and no anemia followed up for 12 months
Intervention Type
Dietary Supplement
Intervention Name(s)
iron fumerate
Intervention Description
iron fumerate supplementation (6mg/kg/d) for arm 1 iron fumerate supplementation (1mg/kg/d) for arm 2
Primary Outcome Measure Information:
Title
effect of iron supplementation on recurrent upper respiratory tract infections measured by Canadian Acute Respiratory Illness and Flu Scale {CARIFS}
Description
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}
Time Frame
15 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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 .
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohsen S Elalfy, professor
Organizational Affiliation
Ain Shams University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Ehab K Emam, professor
Organizational Affiliation
Ain Shams University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Khaled M Abd-al aziz, professor
Organizational Affiliation
Ain Shams University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Yasmin G El gendy, lecturer
Organizational Affiliation
Ain Shams University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mohamed T Hamza, lecturer
Organizational Affiliation
Ain Shams University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
marian g rizk, ass lect
Organizational Affiliation
Ain Shams University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pediatrics hospital Ain shams University
City
Cairo
Country
Egypt

12. IPD Sharing Statement

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

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