According to different effects of zinc supplements, this study was designed to determine the therapeutic impacts of zinc supplementation to current therapy of pneumonia. In this study, all 3 to 60 months old children admitted in Abuzar hospital with the diagnosis of pneumonia were included. The clinical criteria for diagnosis of pneumonia in a child with cough and breathing problems were: a) Tachypnea: respiratory rate over 45/minutes on the age of 3 months to 6 months and more than 40/minutes in the age of 6 months to one year and more than 30/minutes in the age of 12 months to 60 months; b) Fever: the high temperature of 38.5 rectal; c) Symptoms of respiratory distress. Exclusion criteria: a) malnutrition, b) Symptoms of systemic diseases, c) Diarrhea, d) Known intolerance or allergy to zinc or zinc containing drugs. Studied population consisted of 128 patients (64 individuals receiving zinc supplement and 64 placebos). In this study we evaluated the impact of additional zinc supplement and/or placebo to the conventional therapy, on clinical symptoms and duration of hospitalization.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138810303122N1
Registration date:2010-03-29, 1389/01/09
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-03-29, 1389/01/09
Registrant information
Name
Ehsan Valavi
Name of organization / entity
Ahvaz Jundishapur University
Country
Iran (Islamic Republic of)
Phone
+98 61 1444 3052
Email address
valavi.e@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research of Jundishapur university
Expected recruitment start date
2009-01-20, 1387/11/01
Expected recruitment end date
2010-01-21, 1388/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of Zinc effect on treatment of Pneumonia in pediatric patients (3- 60 mo) admitted in Abuzar hospital in 1388
Public title
The impact of zinc supplement on treatment of pneumonia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 1) age of 3 to 60 mo, 2) Clinical diagnosis of pneumonia: a) Tachypnea: > 45 in 3-6mo, >40 in 6-12mo, >30 in 13-36mo, >25 in 37-60mo b) Fever: >38.5 Rectal c) Respiratory distress: Nasal flaring, intercostals retraction, Central cyanosis d) Rales in chest auscultation e) Infiltration in Chest X ray, 3) Parents satisfaction, 4) The ability of child to drink the drug and placebo
Exclusion criteria: 1) Malnutrition, 2) Additional systemic disease (meningitis, sepsis), 3) Diarrhea (> 3 time watery defecations), 4) Allergy to zinc supplements, 5) Severe respiratory disease, family history of asthma, congenital heart disease, 6) Chest wheezing in physical examination, 7) History of recently using antibiotic
Age
From 1 year old to 4 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
128
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
Ethics committee of Ahvaz Jundishapur university of medical sciences
Street address
Golestan St.
City
Ahvaz
Postal code
Approval date
empty
Ethics committee reference number
پ/8/20/1458
Health conditions studied
1
Description of health condition studied
Pneumonia
ICD-10 code
J18
ICD-10 code description
Pneumonia, organism unspecifide
Primary outcomes
1
Description
Fever improvement
Timepoint
every 4 hr
Method of measurement
Termometer
2
Description
Tachypnea improvement
Timepoint
every 4 hr
Method of measurement
Breathing rate
Secondary outcomes
1
Description
Duration of Hospitalization
Timepoint
on discharge time
Method of measurement
Days from admission
Intervention groups
1
Description
adding Zinc suplement to the conventional drugs: 2 mg/kg
Category
Treatment - Drugs
2
Description
adding placebo to the conventional drugs
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Abuzar Hospital
Full name of responsible person
Ehsan Valavi
Street address
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Jundishapur university
Full name of responsible person
Mostafa Feghhi
Street address
Golestan St.
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research of Jundishapur university
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Jundishapur university
Full name of responsible person
Ehsan Valavi
Position
Assistant prof.
Other areas of specialty/work
Street address
Pasdaran St, Abuzar Hospital
City
Ahvaz
Postal code
Phone
+98 61 1373 8243
Fax
Email
valavi.e@ajums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Jundishapur university
Full name of responsible person
Ehsan Valavi
Position
Pediatric Nephrologist
Other areas of specialty/work
Street address
Pasdaran st, Abuzar Hospital
City
Ahvaz
Postal code
Phone
+98 61 1373 8243
Fax
Email
valavi.e@ajums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Full name of responsible person
Ehsan Valavi
Position
Other areas of specialty/work
Street address
City
Postal code
Phone
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)