Efficacy of zinc as adjuvant therapy in the treatment of pneumonia in hospitalized children aged 2 months to 5 years in 17 Shahrivar Training Hospital of Rasht- Iran
Study objective: To determine the efficacy of zinc as adjuvant therapy in the treatment of pneumonia in hospitalized children aged 2 months to 5 years in 17 Shahrivar Training Hospital of Rasht- Iran.
Study Design: Randomized, double-blind, placebo-controlled trial.
Study population: children 2 months to 5 years old hospitalized for pneumonia in hospital in 17 Shahrivar Training Hospital of Rasht- Iran.
Main inclusion criteria: children 2 months to 5 years old hospitalized in 17 Shahrivar Hospital of Rasht - Iran with fever (axillary temperature 37.5° C or more) and cough and tachypnea or rales.
Main exclusion criteria: the history of pulmonary disease including asthma, documented heart disease or other chronic disease or immunodeficiency, proven pathologic gastroesophageal reflux disorder, malnutrition or growth failure, and treatment with zinc or a zinc supplement within 3 months past. Sample size: 120 patients (60 patients in each group)
Study intervention (s) and time of this: After obtaining informed consent from the parents, all the patients' basic necessary information including patient demographics, admission temperature and respiratory rate are taken and recorded.The patient will enter to one of two groups, zinc or placebo therapy, by fixed block method method. Nurses shall prescribe oral zinc to the first group and placebo to the second group. The standard treatment will be conducted for both groups includes antibiotics prescribtion.A resident who is unaware of the adjuvant treatment, will follow the patients for response to treatment.
Study outcomes: the primary outcome is normalization of patient's body temperature and respiratory rate. Secondary outcome is hospital discharge or death.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201305072438N2
Registration date:2013-08-04, 1392/05/13
Registration timing:prospective
Last update:
Update count:0
Registration date
2013-08-04, 1392/05/13
Registrant information
Name
Houman Hashemian
Name of organization / entity
Guilan University of medical sciences- Medical faculty- 17 Shahrivar hospital
Country
Iran (Islamic Republic of)
Phone
+98 13 3336 9061
Email address
hashemian@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research of Guilan University of Medical Sciences
Expected recruitment start date
2013-09-23, 1392/07/01
Expected recruitment end date
2014-06-21, 1393/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of zinc as adjuvant therapy in the treatment of pneumonia in hospitalized children aged 2 months to 5 years in 17 Shahrivar Training Hospital of Rasht- Iran
Public title
Efficacy of zinc in the treatment of children with pneumonia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: children 2 months to 5 years old hospitalized in 17 Shahrivar Hospital of Rasht - Iran with fever (axillary temperature 37.5° C or more) and cough and tachypnea or rales.
Exclusion criteria: the history of pulmonary disease including asthma, documented heart disease or other chronic disease or immunodeficiency, proven pathologic gastroesophageal reflux disorder, malnutrition or growth failure, and treatment with zinc or a zinc supplement within 3 months past.
Age
To 5 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
120
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
Guilan University of Medical Sciences- Vice Chancellor for Research
Street address
Namjoo St.- Rasht- Guilan- Iran
City
Rasht
Postal code
Approval date
2013-04-20, 1392/01/31
Ethics committee reference number
9210029702
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 subsidence
Timepoint
Daily during hospitalization
Method of measurement
Degrees Centigrade (axillary method with a mercury thermometer)
2
Description
normalization of patient's respiratory rate
Timepoint
Daily during hospitalization
Method of measurement
The number of breaths per minute (patient observation by pediatric resident)
Secondary outcomes
1
Description
Hospital discharge or death
Timepoint
Daily during hospitalization
Method of measurement
By pediatric resident
Intervention groups
1
Description
Intervention group: oral zinc (zinc sulfate syrup by mouth or gavage) of 20 mg daily for children 12 months and more and 10 mg daily for children less than 12 months, for 7 days