The main purpose of this study is effect of vit C in reduction of UTI complications. There are many complications related to UTI. Because of that, using of some supplements such as Vit C has been recommended for reducing of these complications. Vit C effects on hematopoietic system, urine acidity and growth reducing of gram negative bacteria, main cause of UTI. Until now, there is no complete study about effects of Vit C in UTI complications. This study is a randomized double blind clinical trial study. Within a year; 154 patients with confirmed urinary tract infection (positive culture or clinical signs associated with urine) after obtaining the entry criteria, including girls 3 to 12 years are investigated. Exclusion criteria including out of age 3 to 12 years old and renal anomalies.
The Case group:
We prescribe Ceftriaxon 50-75 mg/kg/IV/daily and then oral Cefexime for 14 days.
The control group:
Conventional therapy and oral vitamin C 250 mg tablets for 14 days.
Clinical symptoms and urine culture after the first 48 hours and 10 days after treatment will be checked in two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201110307942N1
Registration date:2012-04-17, 1391/01/29
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-04-17, 1391/01/29
Registrant information
Name
Ali Ahmad Goodarzi
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 1278 9047
Email address
goudarzi768@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Arak University of Medical Sciences and Health Services - Department of Education - Dr. Ashtiani
Expected recruitment start date
2011-09-23, 1390/07/01
Expected recruitment end date
2012-09-22, 1391/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of vitamin C supplementation in the treatment of urinary tract infection in children
Public title
The effect of vitamin C supplement in the treatment of urinary tract infection in children
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: All of girls who are between age 3 to 12 that diagnosed as an urinary infection by pediatrician are eligible to enter to study.
Exclusion criteria: The girls who are less than 3 years and more than 12 years ; All sick children whose parents disagree to cooperate ; Patients with renal anomalies ; Patients with kidney stones ; Positive urine culture with several types of germs ; Any drug resistant ; Patients who are under other medications ; history of recurrent urinary tract infection ; The inappropriate use of other supplements
Age
From 3 years old to 12 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
154
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
Street address
3848176941، Pardis educational complex ، basij square ، Sardasht ، Arak، Arak University of Medical Sciences-Markazi Province ، Iran
City
Arak
Postal code
3848176941
Approval date
2011-07-04, 1390/04/13
Ethics committee reference number
90-109-11
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
fever
Timepoint
Daily; until 14 days
Method of measurement
Clinical questionnaire
2
Description
Urine culture
Timepoint
48 hours and 10 days after treatment
Method of measurement
Coloni Count
3
Description
Abdominal pain
Timepoint
Daily; until 14 days
Method of measurement
Clinical questionnaire
4
Description
Dysuria
Timepoint
Daily; until 14 days
Method of measurement
Clinical questionnaire
5
Description
Frequent urination
Timepoint
Daily; until 14 days
Method of measurement
Clinical questionnaire
6
Description
Urinary incontinence
Timepoint
Daily; until 14 days
Method of measurement
Clinical questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Control group:We will priscribe routin medication on UTI including cefriaxon 50-75mg/kg/daily/iv/q12h for 2 days and following by cefixime 12mg/kg/daily/q12h for 12 days, orally.
Category
Treatment - Drugs
2
Description
"Case control :
We will priscribe routin medication for UTI plus Vit C 250 mg/daily for 14 days, orally.”
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Amir Kabir Hospital
Full name of responsible person
Yousefi . P. Dr - Goodarzi .A.A.Dr
Street address
Amir Kabir Hospital Education
City
Arak
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Ashtiani CH S.PhD
Street address
3848176941، Pardis educational complex ، basij square ، Sardasht ، Arak، Arak University of Medical Sciences-Markazi Province ، Iran
City
Arak
Grant name
دانشگاه علوم پزشکی اراک
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 and Health Services
Full name of responsible person
Yousefi P . Dr
Position
Assistant Professor
Other areas of specialty/work
Street address
Amir Kabir Hospital ، Arak ، Markazi
City
Arak
Postal code
3819691187
Phone
+98 86 1313 5075
Fax
+98 86 1313 2510
Email
parsayousefichaijan@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences and Health Services
Full name of responsible person
Yousefi P. Dr
Position
The specialty of kidney and urinary
Other areas of specialty/work
Street address
Amir Kabir Hospital
City
Arak
Postal code
3819691187
Phone
+98 86 1313 5075
Fax
+98 86 1313 2510
Email
parsayousefichaijan@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Goodarzi A. A.Dr
Position
Assistant Professor of Pediatrics
Other areas of specialty/work
Street address
Arak Amir Kabir Hospital
City
Arak
Postal code
3819691187
Phone
+98 86 1313 5075
Fax
+98 86 1313 2510
Email
alia763@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)