This study is a clinical trial on 100 children aged 1-5 years admitted in Pediatrics Wards of Kashan Beheshti Hospital with complaints of fever, cough and tachypnea in 2015. Pneumonia is confirmed by chest radiography. Patients with the history of pulmonary disease including asthma, documented heart disease or other chronic disease, immunodeficiency, proven pathologic gastroesophageal reflux disorder and malnutrition or growth failure are excluded from the study. Patients randomly assign into two groups. Intervention group receive zinc sulfate prepared by Farabi Company and the control group will receive placebo 1 milligram per kilogram of body weight daily for 7 days. Treatment protocols for pneumonia shall be conducted in two groups. Duration of fever, cough, tachypnea and hospitalization will be recorded by the question of mothers and study of dossier.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014052711145N11
Registration date:2015-03-07, 1393/12/16
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-03-07, 1393/12/16
Registrant information
Name
Mohammad Reza Sharif
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 5554 0026
Email address
sharif_m@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kashan University of Medical Sciences
Expected recruitment start date
2015-03-06, 1393/12/15
Expected recruitment end date
2016-03-05, 1394/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of zinc sulfate on duration of pediatric pneumonia
Public title
The effect of zinc sulfate on the improvement of pediatric pneumonia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: children 1 to 5 years old hospitalized in Kashan Beheshti Hospital; fever (axillary temperature 37.5° C or more); cough; tachypnea. Exclusion criteria: the history of pulmonary disease including asthma; documented heart disease or other chronic disease; immunodeficiency; proven pathologic gastroesophageal reflux disorder; malnutrition or growth failure; treatment with zinc or a zinc supplement within 3 months past.
Age
From 1 year old to 5 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Kashan University of Medical Sciences
Street address
Kashan University of Medical Sciences, Ghotbe Ravandi Blvd, Kashan, Iran
City
Kashan
Postal code
Approval date
2015-02-10, 1393/11/21
Ethics committee reference number
5341
Health conditions studied
1
Description of health condition studied
Pneumonia
ICD-10 code
J18.9
ICD-10 code description
Pneumonia, unspecified
Primary outcomes
1
Description
Fever improvement
Timepoint
q 6 hour
Method of measurement
Mercury thermometer with axillary method
2
Description
Cough improvment
Timepoint
Daily
Method of measurement
Asking from mother
3
Description
Tachypnea improvement
Timepoint
Daily
Method of measurement
Breathing rate
Secondary outcomes
1
Description
Duration of hospital stay
Timepoint
At discharge
Method of measurement
Days recorded in dossier
Intervention groups
1
Description
Intervention group: Oral administration of Zinc sulfate 1mg (1cc) / kg daily for 7 days
Category
Treatment - Drugs
2
Description
Control group: Oral administration of placebo solution 1cc / kg daily for 7 days