The effect of potassium citrate in treatment of 2 - 7mm diameter urinary tract stones in children without any metabolic or infectious risk factor of nephrolithioasis
The aim of our study was assessment of effect of potassium citrate therapy on pediatric nephrolithioasis..All less than 16 years old patients with a history of kidney stone with 2-7 mm diameter on kidney ultrasonography will be enrolled in study. Stone is defined as an opacity with more than 2 mm diameter and posterior shadow on kidney ultrasound. All patients will be evaluated for metabolic and infectious risk factors of renal stone formation. Patients with 2-7mm diameter stones and no such risk factors will be enrolled in study. The exclusion criteria is urinary tract infection, renal failure, surgical or lithotripsy intervention and incomplete follow up. Patients would put on two groups; group 1 patients were treated with 1-2ml/kg potassium citrate daily and group 2 patients received no drug. The supportive therapy was performed for all patients in two groups. The follow up by serial ultrasound was done every 3 months. The efficacy of therapy was assessed as the reduction in the number, maximum stone size and total stone burden. The response of therapy is defined as 5 grade ; worst, no change, less than 50% improvement, 50% or more improvement and cure.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014122420419N2
Registration date:2017-07-14, 1396/04/23
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-07-14, 1396/04/23
Registrant information
Name
Hamid Mohammadjafari
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3331 3866
Email address
hmjafari@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Mazandaran University of medical sciences
Expected recruitment start date
2015-10-19, 1394/07/27
Expected recruitment end date
2017-03-20, 1395/12/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of potassium citrate in treatment of 2 - 7mm diameter urinary tract stones in children without any metabolic or infectious risk factor of nephrolithioasis
Public title
The efficacy of potassium citrate in children with nephrolithiasis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: All less than 16 years old patients with a history of kidney stone with 2-7 mm diameter on kidney ultrasonography without any infectious or metabolic risk factors including hypercalciuria, uricosuria, cystinuria, hyperoxaluria and hypocitraturia.
Exclusion criteria: urinary tract infection؛ renal failure؛ surgical or lithotripsy intervention ؛ incomplete follow up.
Age
From 2 months old to 16 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
The patients put in one of two groups serially.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mazandaran University of Medical Sciences
Street address
Vice Chancellor for research of Mazandaran University of Medical Sciences, Moalem square, sar
City
Sari
Postal code
4818856361
Approval date
2015-09-23, 1394/07/01
Ethics committee reference number
IR.MAZUMS.REC.94-1423
Health conditions studied
1
Description of health condition studied
Nephrolithiasis
ICD-10 code
N20
ICD-10 code description
Nephrolithiasis NOS Renal calculus or stone Staghorn calculus Stone in kidney
Primary outcomes
1
Description
Stone number
Timepoint
Before and 3 and 6 months after intervention
Method of measurement
Alteration in stone number after intervention as millimeter on kidney sonography
2
Description
Total stone mass
Timepoint
Before and 3 and 6 months after intervention
Method of measurement
Alteration in sum of all stones size after intervention as millimeter on kidney sonography
3
Description
stone size
Timepoint
Before and 3 and 6 months after intervention
Method of measurement
Alteration in stone size after intervention as millimeter on kidney sonography
Secondary outcomes
1
Description
-
Timepoint
-
Method of measurement
-
Intervention groups
1
Description
Intervention group 1: Potassium citrate 1-2 ml/kg/ day in 2-3 divided doses. The drug will be provided by pharmacy faculty of Mazandaran university of medical sciences.
Category
Treatment - Drugs
2
Description
Control group: No intervention and no drug for treatment
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Booali
Full name of responsible person
Hamid Mohammadjafari
Street address
Pediatric ward, Booali hospital, Pasdaran Avenue, Sari
City
Sari
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Mazandaran University of Medical Sciences
Full name of responsible person
َAhmadali Enayati
Street address
Vice Chancellor for research of Mazandaran University of Medical Sciences, Moalem square, sari
City
sari
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 Mazandaran 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
Mazandaran University of Medical Sciences
Full name of responsible person
Zahra Tahernassab
Position
GP
Other areas of specialty/work
Street address
Pediatric Ward, booali hospital, Passdaran avenue, Sari
City
sari
Postal code
Phone
+98 11 3334 3018
Fax
Email
hamidmj46@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Hamid Mohammadjafari
Position
subspecialist
Other areas of specialty/work
Street address
Pediatric ward, Boali hospital, Passdaran Street, Sari
City
sari
Postal code
4818856361
Phone
+98 11 3334 3018
Fax
Email
hamidmjaafari@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of medical sciences
Full name of responsible person
Hamid Mohammadjafari
Position
professor
Other areas of specialty/work
Street address
Pediatric ward, Boali hospital, passdaran Avenue, Sari
City
Sari
Postal code
4818856361
Phone
+98 33313866
Fax
+98 11 3334 3506
Email
hamidmjaafari@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)