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Effect of L-carnitine on the metabolites of 24-hour urine in patients with a history of recurrent stone formation.

Protocol summary

Study aim
Effect of L-carnitine on the metabolites of 24-hour urine in patients with a history of recurrent stone formation
Design
Phase 2 clinical trial, No control group,No blinding , Sample size of 30 patients
Settings and conduct
Place of study: Urology clinic of Golestan Hospital in Ahwaz . 24-hour urine-related markers (including calcium, oxalate, uric acid and citrate) before treatment is recorded. Patients are then followed for 2 weeks without drug treatment and on a regular diet. At the end of two weeks, the 24-hour urine is collected again and assessed for calcium, oxalate, uric acid and citrate. They are treated with only L-carnitine at a dose of 1 g daily. During the course of treatment with L-carnitine, the patients' diet was monitored for similarity to the first two weeks of follow-up.At the end of the eighth week, 24-hour urine is collected and evaluated for calcium, oxalate, uric acid, and citrate.
Participants/Inclusion and exclusion criteria
Inclusion criteria include patients with a history of renal stone passage and patients undergoing surgical or non-surgical(extracorporal shock wave lithotripsy) surgery for kidney stones or ureteral stones.Exclusion criteria include patients who first have kidney stones and patients with anatomical disorders (ureteral stenosis) , patients with endocrine disorders including hyperparathyroidism, diabetes, metabolic syndrome, cystinorrhoea, and patients who have undergone drug therapy other than l-carnitine for kidney or ureteral stone
Intervention groups
Patients with a history of recurrent stone formation that treated with vial L-carnitine for one gram daily for eight weeks
Main outcome variables
24-hour urine calcium, 24-hour urine uric acid, 24-hour urine oxalate and 24-hour urine citrate

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20191209045675N1
Registration date: 2020-01-15, 1398/10/25
Registration timing: registered_while_recruiting

Last update: 2020-01-15, 1398/10/25
Update count: 0
Registration date
2020-01-15, 1398/10/25
Registrant information
Name
Naser Tabibian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3374 3033
Email address
tabibian.n@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-01-10, 1398/10/20
Expected recruitment end date
2020-05-19, 1399/02/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of L-carnitine on the metabolites of 24-hour urine in patients with a history of recurrent stone formation.
Public title
Effect of L-carnitin on the stone formation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with a history of renal stone passage Patients undergoing surgical or non-surgical (ESWL) surgery for kidney or ureteral stones
Exclusion criteria:
Patients with anatomical disorders Patients who first have kidney stones Patients with endocrine disorders including hyperparathyroidism, diabetes mellitus, metabolic syndrome, cystinuria .. Patients who have been on medications other than L-carnitine for kidney or ureteral stones
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Ahvaz Jundishapur University of Medical Sciences
Street address
University City, Vice Chancellor for Research and Technology Ahvaz Jundishapur University of Medical Sciences
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Approval date
2019-11-27, 1398/09/06
Ethics committee reference number
IR.AJUMS.REC.1398.633

Health conditions studied

1

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

Primary outcomes

1

Description
24 hour urine calcium
Timepoint
Before intervention and 8 weeks after starting L-carnitine vial
Method of measurement
Colorimetric

2

Description
24 hour urine oxalate
Timepoint
Before intervention and 8 weeks after starting L-carnitine vial
Method of measurement
Colorimetric

3

Description
24 hour urine uric acid
Timepoint
Before intervention and 8 weeks after starting L-carnitine vial
Method of measurement
Colorimetric

4

Description
24 hour urine citrate
Timepoint
Before intervention and 8 weeks after starting L-carnitine vial
Method of measurement
Colorimetric

Secondary outcomes

empty

Intervention groups

1

Description
This study has no control group.The intervention group consisted of subjects with renal stone that had a history of recurrent stone formation for 8 weeks receiving one gram of oral vial L-carnitine daily (a number of one gram of oral vial) of Zist Takhmir pharmaceutical company product.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Urology Clinic of Golestan Hospital of Ahvaz
Full name of responsible person
Dr. Alireza Kheradmand
Street address
Urology Clinic, Golestan Hospital, Farvardin Ave, Golestan Blvd
City
Ahvaz
Province
Khouzestan
Postal code
6135733118
Phone
+98 61 3374 3033
Email
n_tabibian7@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Alireza kheradmand
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
15794-61357
Phone
+98 61 3373 8594
Email
info@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Naser Tabibian
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Urology
Street address
Golestan Hospital, Farvardin Ave., Golestan Blvd.
City
Ahvaz
Province
Khouzestan
Postal code
6135733118
Phone
+98 61 3374 3033
Email
n_tabibian7@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Alireza Kheradmand
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Urology
Street address
Golestan Hospital, Farvardin Ave., Golestan Blvd.
City
Ahvaz
Province
Khouzestan
Postal code
6135733118
Phone
+98 61 3374 3033
Email
kheradmand_a@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Naser Tabibian
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Urology
Street address
Golestan Hospital, Farvardin Ave, Golestan Blvd
City
Ahvaz
Province
Khouzestan
Postal code
6135733118
Phone
+98 61 3374 3033
Email
n_tabibian7@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
Yes - There is a plan to make this available
Title and more details about the data/document
The patient's 24-hour urine results can be published
When the data will become available and for how long
Access time is up to 6 months after the results are published
To whom data/document is available
Information will only be available to researchers working in universities and science centers
Under which criteria data/document could be used
The control of the data and supplementary analyses of the data could be performed under copyright law
From where data/document is obtainable
Applicants can be contacted by email with the author to receive the requested data
What processes are involved for a request to access data/document
Applicants will receive the data from the current study by sending an email to the author responsible for a maximum of one month
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