Evaluation of urine analysis and its normalized in children with urinary infection (Uti) recieve zinc(+zinc) and dont recieve zinc(-zinc)
Comparison of ferequency distribution and its negativity in children with uti,(+zinc)and(- zinc)
Comparison of zinc supplementation in treatment of children with Uti,(+zinc)and(-zinc)
Comparisom of zinc supplementation in improve desease symptoms of children with Uti,(+zinc)and(-zinc)
Comparison of hospitalization time in children with Uti, (+zinc)and(-zinc)
Clinical trial over3 to12 years old children affected to clinical urinary infection hospitalized in the zanjan ayatollah mosavi hospital will be down in1397.Sampleare devided into2 groups of instance and case.The interference group note only will take urinary infection treatment, but also they wil berecieve 1cc/kg zinc sulfat syrup, but instance group is unware of being this interference on case group .All the examples will besend to hospitsl and results of experiments and stopping symptoms during hospitilization will be callected and analysed via the questionnair.
Participants/Inclusion and exclusion criteria
Inclusion criteria:3 to12years old-Uti persistence
Exclusion criteria:Change in treatment-Personal satisfaction-Incorrect use of drug
Intervention groups
Using1cc/kg of zinc sulfat syrup for14 days furthermore than uti treatment
Main outcome variables
Zinc , urinary infection
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181023041439N1
Registration date:2018-12-16, 1397/09/25
Registration timing:retrospective
Last update:2018-12-16, 1397/09/25
Update count:0
Registration date
2018-12-16, 1397/09/25
Registrant information
Name
Nahideh Bizhan
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 24 3344 0087
Email address
2nb1365@zums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-03-21, 1397/01/01
Expected recruitment end date
2018-09-22, 1397/06/31
Actual recruitment start date
2018-03-21, 1397/01/01
Actual recruitment end date
2018-09-22, 1397/06/31
Trial completion date
2018-09-22, 1397/06/31
Scientific title
Evaluation of zinc supplementation with treatment of children with urinary tract infection
Public title
Evaluation of Zinc in urinary tract infection
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
3 to12 years old
Urinary tract infection(Pyelonephritis)
Exclusion criteria:
Change in treatment
Personal satisfaction
Incorrect use of drug
Age
From 3 years old to 12 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
52
Actual sample size reached:
52
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Afrer a complete description and consciously satisfaction a gruop of childen receive zinc sulfat furthermore Urinary tract infection treatment and childeren themselves and theire observant dont khnow that the control group will not get zinc sulfat ,the control group that just recieve urinary tract infection treatment is unaware of extance of interference group they took zinc syrup
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Zanjan university of medical Sciences
Street address
End of mahdavi street,Shahrak karmandan Blvd.,Zanjan Town,
City
Zanjan
Province
Zanjan
Postal code
94149-74877
Approval date
2018-04-26, 1397/02/06
Ethics committee reference number
IR.ZUMS.REC.1397.010
Health conditions studied
1
Description of health condition studied
Urinary infection
ICD-10 code
N39.0
ICD-10 code description
Urinary tract infection, site not specified
Primary outcomes
1
Description
Percent ofChildrene with urinary tract infection (Positive urine culture)
Timepoint
Evaluation of urine culture after48 hour and 14day after bigining of zinc
Method of measurement
Urine analysis and urine culture
Secondary outcomes
1
Description
"End of fever"
Timepoint
"During hospitilization"
Method of measurement
"Questionnaire"
2
Description
"Dysuria"
Timepoint
"During hospitilization"
Method of measurement
"Questionnaire"
3
Description
"Stomach pain"
Timepoint
"During hospitilization"
Method of measurement
"Qustonnaire"
4
Description
"Duration of hispitilization"
Timepoint
"During hospitilization"
Method of measurement
"Queationnaire"
Intervention groups
1
Description
"Intervention group": 26 of 3 to12 years old child from both girl and boy affected to clinical urinary infection hospitalized in the zanjan ayatollah mosavi hospital in1397 that have inclusion criteria have fever and urinary and stomach symptoms and positive urinr analysis with pyelonephritis that note only will take urinary infection treatment cefteriaxon50to75 mg/kg/day/Iv and oral cefexim if nescessary, but also they wil berecieve 1cc/kg zinc sulfat syrup of darupakhsh with density 5mg in 5ml daily for14 days,at list one hour befor or 2 hour after meal.All the examples will besend to hospitsl and results of experiments and stopping symptoms during hospitilization will be callected and analysed via Queationnaire.
Category
Treatment - Drugs
2
Description
"Control group": 26 of 3 to12 years old from child both girl and boy with uti that dont recieve any intervention forthurmore than uti treatment
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Zanjan University of Medical Sciences, Mousavi Hospital
Full name of responsible person
Nahideh Bizhan
Street address
Gavazang Road.,Zanjan
City
Zanjan
Province
Zanjan
Postal code
4513956183
Phone
+98 24 3331 3001
Fax
+98 24 3313 1203
Email
Mousavihospital@zums.ac.ir
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Alireza Shoghli
Street address
Azadi Blv,Zanjan Town
City
Zanjan
Province
Zanjan
Postal code
4515613191
Phone
+98 24 3342 0677
Fax
+98 24 3422 4770
Email
research@zums.ac.ir1
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zanjan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Nahideh Bizhan
Position
Assistant
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
End of mahdavi blv.,Karmandan Ave.,Zanjan Town
City
Zanjan
Province
Zanjan
Postal code
4513956183
Phone
+98 24 3344 0300
Fax
Email
2nb1365@zums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Nahideh Bizhan
Position
Assistant
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
End of mahdavi blv,shahrsk karmandan,zanjan Town
City
Zanjan
Province
Zanjan
Postal code
4513934799
Phone
+98 24 3344 0300
Fax
Email
2nb1365@zums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Nahideh Bizhan
Position
Assistant
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
End of mahdavi blv,,karmandan Ave,Zanjan Town,
City
Zanjan
Province
Zanjan
Postal code
4513934799
Phone
+98 24 3344 0300
Fax
Email
2nb1365@zums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD