In this double blind randomized controlled trial which took place in Arak , Amirkabir Hospital , 152 children who got divided into two groups of case and control were treated with antibiotics for 14 days. In addition the case group received vitamin E supplementation adjacent to therapy. After 14 days we assessed them for time of negative culture results and cessation of clinical signs and symptoms of UTI.
General information
Acronym
Vitamin E and UTI in children
IRCT registration information
IRCT registration number:IRCT201305199766N2
Registration date:2013-06-12, 1392/03/22
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-06-12, 1392/03/22
Registrant information
Name
Mohammadreza Firouzifar
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 7741 9732
Email address
src@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Arak University of Medical Sciences
Expected recruitment start date
2012-12-20, 1391/09/30
Expected recruitment end date
2013-12-21, 1392/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of vitamin E supplementation in the treatment of UTI in children
Public title
Effect of vitamin E in the treatment of UTI in children
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criterion: the diagnosis of urinary tract infection.
Exclusion criteria: genito urinary anomalies; sacrum anomalies; baseline scar on kidneys; disrupted VCUG; persistent bacteriuaria; history of recurrent UTI's; bad compliance to therapy; positive cultures with more than one organism and renal calculi.
Age
From 3 years old to 12 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
152
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double 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 Ethics Committee
Street address
Arak University of Medical Sciences Ethics Committee,Arak University of Medical Sciences, Arak, Iran
City
Arak
Postal code
Approval date
2012-11-28, 1391/09/08
Ethics committee reference number
91-138-8
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
time of fever cessation
Timepoint
day
Method of measurement
counting the days till there is no fever present
2
Description
time of dysuria cessation
Timepoint
day
Method of measurement
counting the days till there is no dysuria present
3
Description
time of frequency cessation
Timepoint
day
Method of measurement
counting the days till there is no frequency present
4
Description
time of urgency cessation
Timepoint
day
Method of measurement
counting the days till there is no urgency present
5
Description
time of dribbling cessation
Timepoint
day
Method of measurement
counting the days till there is no dribbling present
6
Description
time of incontinence cessation
Timepoint
day
Method of measurement
counting the days till there is no incontinence present
7
Description
time of abdominal pain cessation
Timepoint
day
Method of measurement
counting the days till there is no abdominal pain present
Secondary outcomes
1
Description
urine culture
Timepoint
48 h after the start of treatment and 7-10 days post treatment
Method of measurement
it is positive if there are more than 100000 CFU
Intervention groups
1
Description
control : 50-75 mg/kg/day of IV ceftriaxone for inpatients and cefixime syrup 8mg/kg/day for outpatients for overall time of 14 days
Category
Treatment - Drugs
2
Description
case :50-75 mg/kg/day of IV ceftriaxone for inpatients and cefixime syrup 8mg/kg/day for outpatients for overall time of 14 days + 100 units Vitamin E for 14 days
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Arak Amirkabir Hospital
Full name of responsible person
Dr. Parsa Yousefi
Street address
Dept of Pediatrics, Amirkabir hospital. alamolhoda st.
City
Arak
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Davood Hekmatpoo
Street address
Arak University of Mecial Sciences , Basij Sq,Arak
City
Arak
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak University of Medical Sciences
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
Arak University of Medical Sciences
Full name of responsible person
Dr Sara Rasti
Position
MD, resident of pediatrics
Other areas of specialty/work
Street address
Amirkabir hospital
City
Arak
Postal code
Phone
+98 86 1417 3645
Fax
Email
rasti@arakmu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Parsa Yousefi
Position
Pediatric Nephrologist
Other areas of specialty/work
Street address
Dept of pediatrics , Amirkabir hospital , Alamolhoda st, Arak
City
Arak
Postal code
Phone
+98 861417350
Fax
Email
parsayousefichaijan@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Student research committee, Arak University of Medical sciences
Full name of responsible person
Mohammad Reza Firouzifar
Position
Student of medicine
Other areas of specialty/work
Street address
Arak University of Medical Sciences, Basij square
City
Arak
Postal code
Phone
Fax
Email
dr.firouzifar@arakmu.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)