The Urinary Tract Infection is an illness with prominent symptoms of fever, abdominal pain, urgency, dysuria, frequency, dribbling and urinary incontinence. UTI is one of the most common diseases in children. Zinc is an essential trace element. Symptoms attributable to zinc deficiency include growth failure, impaired immunity and resistance to infection. The aim of this study is to evaluate the effectiveness of zinc supplementation in the treatment of children with UTI. This is a randomized clinical trial conducted on 200 children between 3-12 years old( female ) with UTI and without norogenic bladder, anatomical abnormalities, or any other malformations or kidney stones. Patients were divided into intervention and control groups. Subjects in the intervention group received zinc (1mg/kg/day) supplementation while control group received usual antibiotic treatment without zinc supplementation. Treatment outcomes including lab test, clinical condition and UTI symptoms including fever, dysuria and urinary frequency were compared in the two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138903094056N1
Registration date:2010-06-13, 1389/03/23
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-06-13, 1389/03/23
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
2008-04-20, 1387/02/01
Expected recruitment end date
2009-05-22, 1388/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effectiveness of zinc supplementation in children with urinary tract infection
Public title
Evaluation of the effectiveness of zinc supplementation in children with urinary tract infection
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Female children 3 to 12 years old with UTI, without norogenic bladder, anatomical abnormalities, or any other malformations or kidney stones
Exclusion criteria: Lack of patient cooperation, inappropriate use of prescribed drugs, history of recurrent UTI, those who have been treated for their UTI with drugs other than Ceftriaxon and Cefoxim
Age
From 3 years old to 12 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
200
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 Medical Science University
Street address
Arak University of Medical Sciences
City
Arak
Postal code
3848176941
Approval date
2008-07-21, 1387/04/31
Ethics committee reference number
87/40/2
Health conditions studied
1
Description of health condition studied
Urinary tract infection
ICD-10 code
N39.0
ICD-10 code description
Urinary tract infection, site not specified
Primary outcomes
1
Description
Urinary Tract Infection
Timepoint
14 days after treatment (Daily 14 days) - 7 to 10 days after the end of treatment ( Urine Culture)
Method of measurement
Asking mother and child - Results of urine tests
2
Description
Dysuria
Timepoint
14 days after treatment (Daily 14 days) - 7 to 10 days after the end of treatment ( Urine Culture)
Method of measurement
Asking mother and child - Results of urine tests
3
Description
Abdominal pain
Timepoint
14 days after treatment (Daily 14 days) - 7 to 10 days after the end of treatment ( Urine Culture)
Method of measurement
Asking mother and child
4
Description
Fever
Timepoint
14 days after treatment (Daily 14 days) - 7 to 10 days after the end of treatment ( Urine Culture)
Method of measurement
Asking mother and child - Thermometer
5
Description
Frequency
Timepoint
14 days after treatment (Daily 14 days) - 7 to 10 days after the end of treatment ( Urine Culture)
Method of measurement
Asking mother and child - Results of urine tests
Secondary outcomes
1
Description
Anorexia
Timepoint
14 days after treatment
Method of measurement
Mother and child statement
2
Description
Growth failure
Timepoint
6 months after treatment
Method of measurement
Mother's remarks
3
Description
Weight loss
Timepoint
Three month after treatment
Method of measurement
Mother's remarks
Intervention groups
1
Description
In the case group with zinc sulfate (1mg/kg/day)
Category
Treatment - Drugs
2
Description
In the control group without zinc supplementation
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
Pediatric clinic, Amirkabir Hospital
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?