Infection is the most common disorder of urinary tract system among children. Having no definite sign and symptoms, some cases of UTI present with weight loss, FTT and anorexia. Regarding its complications, drug resistance and side effects, pharmacologic intervention to induce sooner convalescence with shorter period of drug consumption seems logic. Vitamin C enhances response to therapy in many hosts and has an important role in immune homeostasis. In this article, we assess possible effect of Vitamin C in treating children with UTI admitted in Amir Kabir Hospital in Arak city.
This is a clinical trial, recruiting 159 patients admitted due to UTI. We randomized the patients into two groups of case & control; due to poor compliance, 7 patients were omitted from study. In case group, children were treated with Vit C 250 mg daily for 14 days. Both groups were given routine antibiotic regime for UTI (ceftiraxone 50-75 mg/kg/day/iv for admitted patents followed by Cefixime 8mg/kg/day/po for outpatients). At the end, 152 admitted patients suffering with UTI (with no underlying disease) were assessed in terms of treatment efficacy according to their clinical and urine culture results. Data were analyzed using kai-2 Ficher and T test.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015073113366N5
Registration date:2017-02-19, 1395/12/01
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-02-19, 1395/12/01
Registrant information
Name
Parsa Yousefi Chaijan
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 1312 1964
Email address
dr.yousefi@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Arak University of Medical Sciences
Expected recruitment start date
2011-06-22, 1390/04/01
Expected recruitment end date
2012-02-20, 1390/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of complementary Vitamin C on pediatrics urinary tract infection
Public title
Effect of Vitamin C on pediatrics urinary tract infection
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: the positive urinary tract infection; absence of congenital kidney disease and consent to participate in research project. Exclusion criteria: any reason patients want to leave the study and not satisfied to use their personal data in the study.
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:
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
Street address
Arak, Sardasht, Arak University of Medical Sciences
City
arak
Postal code
Approval date
2011-06-15, 1390/03/25
Ethics committee reference number
90-109-11
Health conditions studied
1
Description of health condition studied
Urinary tract infection
ICD-10 code
NO39.0
ICD-10 code description
Urinary tract infection, site not specified
Primary outcomes
1
Description
Urinary tract infection
Timepoint
Before and after drug consumption which is in a period of 14 days.
Method of measurement
Urine culture
Secondary outcomes
empty
Intervention groups
1
Description
Add vitamin C to common treatment of urinary tract infections
Category
Treatment - Drugs
2
Description
Ceftriaxone at a dose of 50- 75 mg / kg / day / iv used in both intervention and control groups, which is in a period of 14 days.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Pediatric clinic of Amir Kabir hospital
Full name of responsible person
Street address
City
Arak
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mohammad Rafiei
Street address
Arak, Sardasht, Arak University of Medical Sciences
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
Person responsible for scientific inquiries
Contact
Name of organization / entity
Amir Kabir Hospital
Full name of responsible person
Parsa Yousefi Chaijan
Position
Associate Professor of Pediatric Nephrology
Other areas of specialty/work
Street address
Arak, street Alam al-Hoda, Amir Kabir Hospital
City
Arak
Postal code
Phone
+98 86 3313 4717
Fax
Email
dr.yousefi@arakmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Amir Kabir Hospital
Full name of responsible person
Parsa Yousefi Chaijan
Position
Associate Professor of Pediatric Nephrology
Other areas of specialty/work
Street address
Arak, street Alam al-Hoda, Amir Kabir Hospital
City
Arak
Postal code
Phone
00
Fax
Email
dr.yousefi@arakmu.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)