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

May 27, 2020 updated by: yasmin gamal el gendy, Ain Shams University

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1000

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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}
Time Frame: 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}
15 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ain Shams University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 19, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 22, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 26, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 28, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 27, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1-elalfy

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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