Clinical trial NCT02398968: 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
Overall status: COMPLETED
Phase: NA
Conditions: Recurrent Upper Respiratory Tract Infections
Iron Deficiency Anemia
Keywords: Iron
RURTIs
CARIFS
children
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2015-03-26
Enrollment: 1000
Sex: ALL
Minimum age (years): 6
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

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 .

Primary outcomes:
measure: effect of iron supplementation on recurrent upper respiratory tract infections measured by Canadian Acute Respiratory Illness and Flu Scale {CARIFS}
timeFrame: 15 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Pediatrics hospital Ain shams University
Study officials:
affiliation: Ain Shams University
name: Mohsen S Elalfy, professor
role: STUDY_DIRECTOR
affiliation: Ain Shams University
name: Ehab K Emam, professor
role: STUDY_CHAIR
affiliation: Ain Shams University
name: Khaled M Abd-al aziz, professor
role: STUDY_CHAIR
affiliation: Ain Shams University
name: Yasmin G El gendy, lecturer
role: PRINCIPAL_INVESTIGATOR
affiliation: Ain Shams University
name: Mohamed T Hamza, lecturer
role: STUDY_CHAIR
affiliation: Ain Shams University
name: marian g rizk, ass lect
role: PRINCIPAL_INVESTIGATOR
References: