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

Ain Shams University

Status: Completed

Conditions: Iron Deficiency Anemia; Recurrent Upper Respiratory Tract Infections

Treatments: Dietary Supplement: iron fumerate

Study type: Interventional

Funder types: Other

Identifiers

NCT02398968

1-elalfy

Details and patient eligibility

About

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 .

Full 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

Enrollment: 1,000 patients

Sex: All

Ages: 6 to 15 years old

Volunteers: Accepts 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 .

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,000 participants in 3 patient groups

RURTI+IDA+iron therapy

Active Comparator group

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

Treatment:

Dietary Supplement: iron fumerate

B1:RURTI+no anemia+iron maintenance

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: iron fumerate

B2:RURTI+no anemia

No Intervention group

Description:

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