Survey of cranberry capsule on prevention of recurrent urinary tract infection in children and its replacement with routine antibiotics
Design
A randomized clinical trial with control group, parallel group design and without blinding, with a sample size of 50 patients
Settings and conduct
The study place will be the Nephrology clinic of Sabzevar Heshmatie Hospital.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Children with recurrent urinary tract infection; Written consent from parents.Non-inclusion criteria: Children less than one month; Patients who are unable to use the medication in question due to the patient's departure from the usual route to complication or deterioration of the patient's general condition.
Intervention groups
Intervention group: Children with recurrent urinary tract infection will be treated using 300 mg cranberry capsule daily for one month. Control group: Children with recurrent urinary tract infection will receive 10 mg /kg Nitrofurantoin (an antibiotic) daily for 1 month.
Main outcome variables
Urinary tract infection
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191207045640N1
Registration date:2020-02-11, 1398/11/22
Registration timing:retrospective
Last update:2020-02-11, 1398/11/22
Update count:0
Registration date
2020-02-11, 1398/11/22
Registrant information
Name
Zahra Boluki
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 4262 7414
Email address
zahra.boluki@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-01-05, 1398/10/15
Expected recruitment end date
2020-01-20, 1398/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of Cranberry and Nitrofurantoin on recurrent urinary tract infection in children
Public title
Surveying cranberry effect on urinary tract infection in children
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
All children with recurrent urinary tract infection
Written parental consent
Exclusion criteria:
Children under the age of one month
Parental dissatisfaction
Patients who are unable to use the medication in question due to the patient's departure from the usual route to complication or deterioration
Age
From 1 month old to 16 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
In order to do simple random allocation, the numbered cards with odds and even numbers are placed in a bag and an individual unaware of the numbers on the cards will give the cards to the parent. Therefor the patients will be randomly assigned to the intervention and control groups.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Sabzevar University of Medical Sciences
Street address
Heshmati Hospital, Assad Abadi street, Sabzavar
City
Sabzevar
Province
Razavi Khorasan
Postal code
9319719746
Approval date
2019-12-08, 1398/09/17
Ethics committee reference number
IR.MEDSAB.REC.1398.073
Health conditions studied
1
Description of health condition studied
Recurrent urinary tract infection
ICD-10 code
N39.0
ICD-10 code description
Urinary tract infection, site not specified
Primary outcomes
1
Description
Urinary tract infection
Timepoint
One week after treatment, then every one month up to three months and then every two months up to 6 months
Method of measurement
Urine analysis and urine culture
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Blueberry capsule 300 mg once daily for three months after treatment for UTI and for children who cannot use the capsule, the mother is asked to dissolve and use the contents of the capsule in water.
Category
Treatment - Drugs
2
Description
Control group: Nitrofurantoin antibiotic with prophylactic dose (one third of therapeutic dose) 1 mg / kg daily (maximum daily dose 100 mg) in the form of 50 mg tablets Mehr Daro Company based on baby weight for three months They will receive urinary tract infection after treatment.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Heshmati Specialty Hospital
Full name of responsible person
Zahra Boluki
Street address
Assad Abadi street
City
Sabzevar
Province
Razavi Khorasan
Postal code
9319719746
Phone
+98 51 4261 4974
Email
zahra.boluki@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Hosen Shariatmadari
Street address
Sabzevar University of Medical Sciences Headquarters, Assad Abadi street
City
Sabzevar
Province
Razavi Khorasan
Postal code
9613873119
Phone
+98 51 4401 1096
Email
vc.dmr@medsab.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sabzevar 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
Sabzevar University of Medical Sciences
Full name of responsible person
Zahra Boluki
Position
Intern
Latest degree
A Level or less
Other areas of specialty/work
Medical Intern
Street address
Puyesh 1, Puyesh alley, Adab street, Basij Town
City
Neyshaboor
Province
Razavi Khorasan
Postal code
9319719746
Phone
+98 51 4261 4974
Email
zahra.boluki@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Zahra Boluki
Position
intern
Latest degree
A Level or less
Other areas of specialty/work
Medical Education
Street address
Puyesh 1, Puyesh alley, Adab street, Basij Town
City
Neyshaboor
Province
Razavi Khorasan
Postal code
9319719746
Phone
+98 51 4261 4974
Email
zahra.boluki@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Zahra Boluki
Position
intern
Latest degree
A Level or less
Other areas of specialty/work
Medical Education
Street address
Puyesh 1, Puyesh alley, Adab street, Basij Town
City
Neyshaboor
Province
Razavi Khorasan
Postal code
9319719746
Phone
+98 51 4261 4974
Email
zahra.boluki@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
I haven't decided yet - its release schedule is still unclear
When the data will become available and for how long
I haven't decided yet - its release schedule is still unclear
To whom data/document is available
I haven't decided yet - its release schedule is still unclear
Under which criteria data/document could be used
I haven't decided yet - its release schedule is still unclear
From where data/document is obtainable
I haven't decided yet - its release schedule is still unclear
What processes are involved for a request to access data/document
I haven't decided yet - its release schedule is still unclear