This randomized, triple-blind, placebo-controlled clinical trial was conducted in 2014 among 68 children and adolescents with recurrent UTI, referred to nephrology clinics of AlZahra and Emam Hossien hospitals, affiliated to Isfahan University of Medical Sciences and the private clinics of pediatrics nephrologists in Isfahan city.
Patients were selected by simple randomized method.
Participants were randomly allocated in two intervention and placebo groups. Patients in intervention group received oral vitamin D drop(DITHRECOL) which was diluted with paraffin with a dose of 1000IU/daily supplied by Caspian tamin pharmaceutical company (Tehran-Iran ) and placebo (paraffin dickflussig.Art.7160. )supplied by Merk(Germany). Medication or placebo was for six months.
The patients were followed up monthly for recurrence of UTI and for reassurance on their compliance for receiving the supplement and placebo. In addition to monthly follow up ,if patients presented with any sign and symptoms of UTI ,urine analysis and culture were performed.
Demographic characteristics of each patient were recorded before intervention. The level of serum vitamin D before and after study and the frequency of UTI during the trial were recorded for each patient and compared between intervention and placebo groups.
Based on serum vitamin D level, children were classified as having vitamin D deficiency (<=19ng/ml), insufficiency (20-30ng/ml) and adequacy (>30ng/ml). Patients in each group were compared according to this classification before and after intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017052221968N2
Registration date:2017-08-10, 1396/05/19
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-08-10, 1396/05/19
Registrant information
Name
Alireza Merrikhi
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3669 1362
Email address
merrikhi@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research of Isfahan University of Medical Sciences
Expected recruitment start date
2014-04-01, 1393/01/12
Expected recruitment end date
2014-12-01, 1393/09/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of vitamin D supplement in prevention of urinary tract infections in children with recurrent urinary tract infection
Public title
Effectiveness of vitamin D supplement in prevention of recurrent urinary tract infections in children
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:Children with documented recurrent UTI who were not in the active phase of UTI ;Children who had no anatomical defects; renal stone; neurogenic bladder; higher grade of reflux (>=grade II); obstructive uropathies and congenital or acquired immune deficiency;Circumcised boys
Exclusion criteria:Patients without appropriate compliance for regular follow up or treatment
Age
From 2 years old to 12 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
68
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
ٍٍEthics Committee of Isfahan University of Medical Sciences
Street address
Hezar jerib street, Isfahan University of Medical Sciences
City
Isfahan
Postal code
81746-73461
Approval date
2014-02-07, 1392/11/18
Ethics committee reference number
393734
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 track infection
Timepoint
monthly
Method of measurement
urine analysis
Secondary outcomes
1
Description
frequency of reccurent urinary track infrvtion
Timepoint
6 months after intervention
Method of measurement
Urine analysis
Intervention groups
1
Description
control group:placebo(paraffin dickflussig.Art.7160.germany) for six months
Category
Placebo
2
Description
Intervention group:oral vitamin D drop(DITHRECOL) which was diluted with paraffin with a dose of 1000IU/daily for six months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Emem Hossein childrens' hospital
Full name of responsible person
Street address
City
Isfahan
2
Recruitment center
Name of recruitment center
Alzahra hospital
Full name of responsible person
Street address
City
Isfahan
3
Recruitment center
Name of recruitment center
Private clinics of pediatrics nephrologists
Full name of responsible person
Street address
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research of Isfahan University of Medical Sciences
Full name of responsible person
Dr. Merrikhi
Street address
Hezar jerib street,Isfahan University of Medical Sciences
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research of Isfahan University of Medical Sciences