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

Iron Deficiency Anemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02398968
• Other study ID #: 1-elalfy
• Status: Completed
• Phase: N/A
• Start date: August 2013
• Est. completion date: May 2016

Study information

• Verified date: May 2020
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 .

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1000
• Est. completion date: May 2016
• Est. primary completion date: April 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 15 Years

Eligibility

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 .

Related Conditions & MeSH terms

• Anemia, Iron-Deficiency
• Communicable Diseases
• Infection
• Iron Deficiency Anemia
• Recurrent Upper Respiratory Tract Infections
• Respiratory Tract Infections

Intervention

Dietary Supplement:
• iron fumerate
iron fumerate supplementation (6mg/kg/d) for arm 1 iron fumerate supplementation (1mg/kg/d) for arm 2

Locations

Country	Name	City	State
Egypt	Pediatrics hospital Ain shams University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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