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Effectiveness of potassium citrate solution in renal microlithiasis treatment in 1 month to 15 years old children

Protocol summary

Study aim
Determination of the effectiveness of potassium citrate solution in the treatment of renal microlithiasis in children one month to 15 years old
Design
A phase 3 clinical trial with one intervention group and one control group as parallel groups, simple randomized by coded card selection, and a sample size of 60
Settings and conduct
In this study, 60 children between the ages of 1 month and 15 years referred to Hajar Hospital in Shahrekord who have microlithiasis less than 3 mm in sonography will randomly be divided into 2 groups by selecting a card. In the first group of children, only conservative and protective measures such as breast milk consumption, prevention of dehydration and less salt consumption will be recommended, and in the second group, in addition to supportive measures, they will be treated with potassium citrate solution for 3 months. Then, to evaluate the presence or absence, size and number of stones, patients in both groups will be examined and compared with sonography after 3 months.
Participants/Inclusion and exclusion criteria
Inclusion criteria: children aged 1 month to 15 years with kidney stones less than 3 mm and parental consent to participate in the study; Exclusion criteria: renal hydronephrosis, multiple stones, urinary reflux, recurrent urinary tract infection
Intervention groups
In one group of children, only conservative and supportive measures such as breastfeeding, dehydration prevention and less salt intake will be recommended, and in the other group, in addition to supportive measures, they will be treated with potassium citrate solution (Combination of 22% potassium citrate powder and 68.8% acetic acid from Merck factory in Germany with distilled water) for 3 months.
Main outcome variables
Number of stones; Size of stones

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20171030037093N40
Registration date: 2020-10-25, 1399/08/04
Registration timing: retrospective

Last update: 2020-10-25, 1399/08/04
Update count: 0
Registration date
2020-10-25, 1399/08/04
Registrant information
Name
Sadra Ansaripour
Name of organization / entity
Shahrekord University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3650 3487
Email address
st_ansari.s@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-01-22, 1398/11/02
Expected recruitment end date
2020-06-25, 1399/04/05
Actual recruitment start date
2020-03-25, 1399/01/06
Actual recruitment end date
2020-08-31, 1399/06/10
Trial completion date
2020-08-31, 1399/06/10
Scientific title
Effectiveness of potassium citrate solution in renal microlithiasis treatment in 1 month to 15 years old children
Public title
Effect of potassium citrate solution in the treatment of renal microlithiasis in children
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Children aged 1 month to 15 years with kidney stones less than 3 mm Patient parents' satisfaction with participating in the study
Exclusion criteria:
Renal hydronephrosis Numerous stones Urinary reflux Recurrent urinary tract infections
Age
From 1 month old to 15 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 60
Actual sample size reached: 60
Randomization (investigator's opinion)
Randomized
Randomization description
In order to randomize the study, simple randomization with individual unit is used, so that patients randomly select one of the cards containing the codes A or B so they enter one of the two treatment 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 Shahrekord University of Medical Sciences
Street address
Vice chancellor for research, Building No. 2, University headquarters, Ayatollah Kashani Blvd
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713492
Approval date
2020-06-07, 1399/03/18
Ethics committee reference number
IR.SKUMS.REC.1399.084

Health conditions studied

1

Description of health condition studied
Renal microlithiasis
ICD-10 code
N20.0
ICD-10 code description
Calculus of kidney

Primary outcomes

1

Description
Number of stones
Timepoint
At the beginning of the study and 3 months after the start of the study
Method of measurement
Sonography

2

Description
Stone size
Timepoint
At the beginning of the study and 3 months after the start of the study
Method of measurement
Sonography

Secondary outcomes

empty

Intervention groups

1

Description
Control group: In this group, children and their parents will only be advised to take conservative and supportive measures such as breast milk consumption, prevention of dehydration and less salt consumption for 3 months.
Category
Treatment - Other

2

Description
Intervention group: In addition to supportive measures, treated with potassium citrate solution (combination of 22% potassium citrate powder and 68.8% acetic acid from the German Merck factory with distilled water that prepared in one center and by one person) for 3 months.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Hajar Hospital
Full name of responsible person
Saeed Mohajeri
Street address
Hajar Hospital, Nursing Street ,Kashan Blvd, Shahrekord City, Chahar Mahal and Bakhtiari
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
۸۸۱۶۷۵۴۶۳۳
Phone
+98 38 3222 0016
Email
dr.saedmohajeri@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Mehraban Sadeghi
Street address
Vice chancellor for research, Building No. 2, University headquarters, Ayatollah Kashani Blvd
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Phone
+98 38 3334 2414
Email
Mehr.sadeghi1ir@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahre-kord 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
Shahre-kord University of Medical Sciences
Full name of responsible person
Saeed Mohajeri
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Shahrekord University of Medical Sciences, Building No. 2, University headquarters, Ayatollah Kashani Blvd
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Phone
+98 38 3227 4004
Email
dr.saedmohajeri@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Saeed Mohajeri
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Shahrekord University of Medical Sciences, Building No. 2, University headquarters, Ayatollah Kashani Blvd
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Phone
+98 38 3227 4004
Email
dr.saedmohajeri@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Saeed Mohajeri
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Shahrekord University of Medical Sciences, Building No. 2, University headquarters, Ayatollah Kashani Blvd
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Phone
+98 38 3227 4004
Email
dr.saedmohajeri@gmail.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
Undecided - It is not yet known if there will be 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
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