The common cold is a viral illness. Major symptoms include rhinorrhea and nasal obstruction with absent or mild fever and lack of any systemic manifestations. Common cold is the most common disease in children. Young children have an average of 6 to 7 colds each year. Some of the complications of common cold are secondary bacterial infections, school absence and excessive cost of treatment. Zinc sulfate has an antiviral effect and can strengthen immune system activity .The aim of this study is to evaluate the efficacy of zinc sulfate in reducing the duration of cold symptoms in children. This is a randomized clinical trial conducted on 112 children between 1-7 years old (male and female) with common cold. Patients were divided into intervention and control groups. Sample size in each group was 56. Subjects in the intervention group received Zinc Sulfate (for 10 days) while control group did not receive Zinc Sulfate. Both groups received usual medications. By means of a questionnaire, duration of symptoms including rhinorrhea and nasal obstruction, cough, sneezing, fever as well as duration of illness, in both groups will be collected and compared. The inclusion criteria are: children between 1 to 7 years old diagnosed by a pediatrician as having common cold based on symptoms and not receiving antibiotics. The exclusion criteria are: parents not willing to participate in the study and antibiotic use.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138903184056N2
Registration date:2010-06-14, 1389/03/24
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-06-14, 1389/03/24
Registrant information
Name
Zahra Moghadasi
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 1417 3517
Email address
moghadasi@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
funded by investigator
Expected recruitment start date
2007-04-21, 1386/02/01
Expected recruitment end date
2007-09-23, 1386/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effectiveness of zinc sulfate in reducing duration of common cold symptoms in children
Public title
Effectiveness of zinc sulfate in common cold symptoms in children
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: children between 1 to 7 years old diagnosed by a pediatrician as having common cold based on symptoms; not receiving antibiotics. Exclusion criteria: parents not willing to participate in the study and antibiotic use.
Age
From 1 year old to 7 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
112
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Arak University of Medical Sciences
Street address
Pardis complex, Basij Sq.,
City
Arak
Postal code
3848176941
Approval date
empty
Ethics committee reference number
1/27/1386
Health conditions studied
1
Description of health condition studied
Cold
ICD-10 code
J00
ICD-10 code description
Acute nasopharyngitis (common cold)
Primary outcomes
1
Description
Nasal obstruction
Timepoint
10 days after starting treatment - Daily for 10 days
Method of measurement
Asking mother and child via a questionnaire
2
Description
Runny nose
Timepoint
10 days after starting treatment-Daily for 10 days
Method of measurement
Asking mother and child via a questionnaire
3
Description
Cough
Timepoint
10 days after starting treatment - Daily for 10 days
Method of measurement
Asking mother and child via a questionnaire
4
Description
Sneezing
Timepoint
10 days after starting treatment - Daily for 10 days
Method of measurement
Asking mother and child via a questionnaire
5
Description
Fever
Timepoint
10 days after starting treatment
Method of measurement
Asking mother and child via a questionnaire -Thermometer
Secondary outcomes
1
Description
Secondary bacterial infections
Timepoint
15- 20 days after the end of treatment
Method of measurement
Pediatrician statement - Blood test results
2
Description
school absence
Timepoint
15- 20 days after the end of treatment
Method of measurement
parental statement
3
Description
Excessive cost for treatment
Timepoint
15- 20 days after the end of treatment
Method of measurement
parental statement
Intervention groups
1
Description
In case group , use of zinc sulfate (1mg/kg) once a day for 10 days
Category
Treatment - Drugs
2
Description
Control group did not receive Zinc Sulfate
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Arak Amirkabir Hospital
Full name of responsible person
Dr Parsa Yousefi
Street address
Amirkabir Hospital, Pediatric clinic
City
Arak
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Saeed Changizi Ashtiyani
Street address
Vice Chancellor for Research
City
Arak
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?