To study the efficacy of Extended-release Urocitra on urinary pH and 24-hour urine citrate in patients with observing the intact pills in feces without chronic diarrhea
To study the efficacy of Extended-release Urocitra on urinary pH and 24-hour urine citrate in patients with observing the intact pills in feces without chronic diarrhea
Design
This clinical trial (quasi experimental), rhse 3, 30 patients, 15 with and 15 without previous observing Extended-release Urocitra intact pills in feces included in the study. All the patients recieved the same treatment, so the randomization is not possible.
Settings and conduct
- Complete questionnaire regarding complete physical exam, measuring fresh urine pH, serum and 24-hour urine metabolite analysis at beginning the study
- the patients in both group will treat with Extended-release Urocitra (Sobhan darou Co.) 10 mg/ TDS till to 4 weeks.
- measuring fresh urine pH 2 weeks after the trial
- measuring fresh urine pH and reassess serum and 24-hour urine metabolite analysis at the end of the study (4 weeks after using pill)
Participants/Inclusion and exclusion criteria
Patients with kidney stone, between 18 and 65 years of old, without evidence of using Extended-release Urocitra during two weeks ago, without history of chronic diarrhea or chronic kidney diseases (stage 3&4), no pregnancy or lactation
Intervention groups
-Intervention group: Patients with previous observing intact pills of Extended-Release Urocitra 10 meq in feces
- Control group: Patients without previous observing intact pills of Extended-Release Urocitra 10 meq in feces
Main outcome variables
fresh urine pH; 24-hour urine citrate
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191026045244N4
Registration date:2022-08-17, 1401/05/26
Registration timing:registered_while_recruiting
Last update:2022-08-17, 1401/05/26
Update count:0
Registration date
2022-08-17, 1401/05/26
Registrant information
Name
Maryam Taheri
Name of organization / entity
Urology and Nephrology Research Center,Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2256 7222
Email address
taheri233@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-04-21, 1401/02/01
Expected recruitment end date
2023-04-21, 1402/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
To study the efficacy of Extended-release Urocitra on urinary pH and 24-hour urine citrate in patients with observing the intact pills in feces without chronic diarrhea
Public title
To study the efficacy of extended-release Urocitra in patients with observing intact pills in feces
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Urolithiasis patients with and without observing extended release Urocitra in feces
Exclusion criteria:
chronic kidney disease (stage 3&4)
pregnancy or lactation
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
30
More than 1 sample in each individual
Number of samples in each individual:
3
The intervention group are urolithiasis patients with previous observing Extended-release Urocitra in feces. Therefore it is not possible to calculate the sample size, exactly. Available patients will include in the trial.
Randomization (investigator's opinion)
N/A
Randomization description
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
urology nephrology research center
Street address
Pasdaran
City
Tehran
Province
Tehran
Postal code
1666663111
Approval date
2022-01-27, 1400/11/07
Ethics committee reference number
IR.SBMU.UNRC.REC.1400.016
Health conditions studied
1
Description of health condition studied
Renal stone
ICD-10 code
Z00.6
ICD-10 code description
Encounter for examination for normal comparison and control in clinical research program
Primary outcomes
1
Description
24-hour urine citrate
Timepoint
after 4 weeks treatment with Extended-release Urocitra
after 4 weeks treatment with Extended-release Urocitra
Method of measurement
Measurement of fresh urine pH by pH meter
3
Description
Investigation of the possibility of recurrence of observing intact pills in the feces of patients with previous proclem
Timepoint
After four weeks
Method of measurement
Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients with prevous history of observing the intact pills of Extended-release Urocitra in feces (without chronic diarrhea), will treated by potassium citrate extended-release, 10 mg, TDS, produced by Sobhan daru company, under brand of Urocitra-ER, for 4 weeks.
Category
Treatment - Drugs
2
Description
Control group: Patients without prevous history of observing the intact pills of Extended-release Urocitra in feces (without chronic diarrhea), will treated by potassium citrate extended-release, 10 mg, TDS, produced by Sobhan daru company, under brand of Urocitra-ER, for 4 weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
urology nephrology research center
Full name of responsible person
Abbas Basiri
Street address
Pasdaran
City
Tehran
Province
Tehran
Postal code
1666663111
Phone
+98 21 2256 7222
Email
basiri@unrc.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Sobhan darou Co
Full name of responsible person
Ali Mortazavi
Street address
west Fatemi
City
Tehran
Province
Tehran
Postal code
1411853695
Phone
+98 21 6656 8181
Email
info@sobhandarou.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Cooperation contract for the implementation of a research project entitled To study the efficacy of Extended-release Urocitra on urinary pH and 24-hour urine citrate in patients with observing the intact pills in feces without chronic diarrhea
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
Industry
Person responsible for general inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Abbas Basiri
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Urology
Street address
Pasdaran
City
Tehran
Province
Tehran
Postal code
166663111
Phone
+98 21 2256 7222
Email
basiri@unrc.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Maryam Taheri
Position
Assisstant professor
Latest degree
Specialist
Other areas of specialty/work
Urology
Street address
Pasdaran
City
Tehran
Province
Tehran
Postal code
1666663111
Phone
+98 21 2256 7222
Email
taheri233@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Maryam Taheri
Position
Assisstant professor
Latest degree
Specialist
Other areas of specialty/work
Urology
Street address
Pasdaran
City
Tehran
Province
Tehran
Postal code
1666663111
Phone
+98 21 2256 7222
Email
taheri233@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
The results and data will be available.
When the data will become available and for how long
6 months after the published related article
To whom data/document is available
Valid academic centers or valid academic persons
Under which criteria data/document could be used
In order to citation, using in the same trials, studies or review articles
From where data/document is obtainable
UNRC data registry affiliated to Shahid Beheshti University of Medical sciences
What processes are involved for a request to access data/document
requet form via email or another valid correspondence