Comparison of the efficacy of potassium citrate and poly citra-k in children and infant with urolithiasis refer child nephrology clinic in age 31day-16years old
The diagnosis and treatment of urolithiasis with no specific symptoms in children is important.All of infant and children with urolithiasis refer to Kosar clinic and after physical examination and completing the questionnare ,in absence of urinary tract infectios, random sampling was done to two groups :therapy with potassium citrate and poly citrate-k.the patients in first, third and sixth and 9th month will be tested with urine test and sonography.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016121931466N1
Registration date:2017-11-19, 1396/08/28
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-11-19, 1396/08/28
Registrant information
Name
Ladan Teymoorzadeh
Name of organization / entity
Ardebil University Of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 45 3371 6980
Email address
j.zare@arums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ardabil University Of Medical Science
Expected recruitment start date
2016-01-21, 1394/11/01
Expected recruitment end date
2016-10-21, 1395/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the efficacy of potassium citrate and poly citra-k in children and infant with urolithiasis refer child nephrology clinic in age 31day-16years old
Public title
Comparison of the efficacy of potassium citrate and poly citra-k in children and infant with urolithiasis
Purpose
Treatment
Inclusion/Exclusion criteria
All of infant and child with urolithiasis refer to Kosar nephrology clinic enter to study.
If there is urinary tract infections,anatomical disorders,kidney disease or need another drugs or another intervention during treatment they were excluded from the study.
Age
From 31 days old to 15 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
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
Ethics committe Of Ardebil University Of Medical Science
Street address
Daneshgah Street, Ardebil
City
Ardebil
Postal code
5618985991
Approval date
2017-01-01, 1395/10/12
Ethics committee reference number
IR.ARUMS.REC.1395.123
Health conditions studied
1
Description of health condition studied
Urolithiasis
ICD-10 code
N23-N20
ICD-10 code description
Calculus of kidney with calculus of ureter
Primary outcomes
1
Description
The size of the stone
Timepoint
The first, Sixth and ninth month
Method of measurement
Sonography
Secondary outcomes
empty
Intervention groups
1
Description
Polycitrate-k.1cc per kg for 9 month
Category
Treatment - Drugs
2
Description
Potassiumcitrate.1cc per kg for 9 month
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Child Nephrology Clinic, Ardebil
Full name of responsible person
Dr Ladan Teymoorzadeh
Street address
Kosar Nephrology Clinic, Ardebil
City
Ardebil
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research of Ardebil University of Medical Science
Full name of responsible person
Dr.Maoud Entezari Asl
Street address
Daneshgah Street ,Ardebil
City
Ardebil
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 Ardebil University of Medical Science
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
Ardebil University Of Medical Science
Full name of responsible person
Ladan Teymoorzadeh
Position
Resident of Pediatrics
Other areas of specialty/work
Street address
Daneshgah Street, Ardebil
City
Ardebil
Postal code
Phone
+98 45 3371 6980
Fax
Email
Ladantey@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ardebil University of Medical Science
Full name of responsible person
Javad Zare Noghabi
Position
Assistan Profesor
Other areas of specialty/work
Street address
BuAli Hospital, Ardebil
City
Ardebil
Postal code
5613643197
Phone
+98 45 3325 2251
Fax
Email
J.zare@arums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ardebil University Of Medical Science
Full name of responsible person
Ladan Teymoorzadeh
Position
Resident of Pediatrics
Other areas of specialty/work
Street address
Moallem Street, Ardebil
City
Ardebil
Postal code
5613643197
Phone
+98 45 3325 2251
Fax
Email
Ladantey@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)