Determination of calcium levels in the urinary tract of patients with renal stone before and after vitamin D supplementation
Design
Study Type: Clinical Trial with Control Group Sample: Patients with urinary stone age 18-65 years old diagnosis of stone and serum vitamin D have less than 30 ng / ml Sample size:90 people were selected
Settings and conduct
Blood samples are taken from patients referring to the nephrology clinic and serum levels of calcium, phosphorus PTH, vitamin D (25 (OH) VitD) are measured, as well as 24-hour urine sample volume, creatinine, calcium, and urine samples. Patients were randomly divided into two groups of 45 each. For 45 patients, oral vitamin D administration will start at 50,000 units for another 45 patients with oral placebo starting 1 month after the end of vitamin D and placebo administration.
Sampling is performed again from both study groups and the above cases are reviewed again
Participants/Inclusion and exclusion criteria
Inclusion criteria: - Patients with kidney stones and vitamin D deficiency
- People aged 18-65 years
- Acceptance to participate in the project
- Signing a written consent
- No vitamin D supplementation before study
- Not having malabsorption syndromes
Conditions of Use: - Drug use including drugs such as diuretics, potassium citrate
- Pregnant women
- Recent stone disposal
- Ureteral stone leads to blockage
Urinary tract infection for the last two weeks
- Systemic infection in the last two weeks
-Following the intervention
Intervention groups
Intervention group 1: Patients with vitamin D level (25 (OH) VitD lower than 30 (ng / ml)) will receive 50,000 units of oral vitamin D daily for 8 weeks.
Intervention group 2: Patients with vitamin D level (25 (OH) VitD less than 30 (ng / ml)) are given weekly placebo for up to 8 weeks.
Main outcome variables
Urine calcium level
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200105046012N1
Registration date:2021-01-03, 1399/10/14
Registration timing:retrospective
Last update:2021-01-03, 1399/10/14
Update count:0
Registration date
2021-01-03, 1399/10/14
Registrant information
Name
Elham Javadian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 54 3329 5586
Email address
elham.javadian1396@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-01-21, 1398/11/01
Expected recruitment end date
2020-07-22, 1399/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of relationship between vitamin D supplementation treatment and hypercalciuria in patients with kidney stones
Public title
Evaluation of relationship between vitamin D supplementation treatment and hypercalciuria in patients with kidney stones
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
- Patients with kidney stones and vitamin D deficiency referred to Zahedan Nephrology Clinic
- People aged 18-65 years
Acceptance to participate in the project
Lack of specific illnesses such as heart failure, kidney or liver disease
Absence of inflammatory or infectious diseases
Not taking medications like diuretics
Not taking corticosteroids
Not taking immunosuppressive drugs
Not taking vitamin D supplement before study
Exclusion criteria:
- Medication including drugs such as diuretics, potassium citrate
- Pregnant women
- Recent stone disposal
Ureteral stone leads to obstruction
Urinary tract infection for the last two weeks
- Systemic infection in the last two weeks
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Data analyser
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization of patients will be done by the responsible researcher using a table of random numbers Randomization will be recorded on an Excel file by the principal investigator. Participants will be randomized via permuted block randomization. Each block will be consistent of sizes of 4 patients. For assignment of each patient to the drug or placebo group, for each patients a unique code consistent of 2 letters and a digit will be assigned. the code will be unique for each patient ( for example code AB1 for first patient). Only the principle investigator will be informed of the assignment of each code to the medication or placebo group
Blinding (investigator's opinion)
Double blinded
Blinding description
1- The nurse who gives the medication to the patients whether or not they are on the medication is not aware
Patients were or were not aware of the drug
3. The laboratory does not know which sample belongs to the control group
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of zahedan University of Medical Sciences
Street address
Sistan and Baluchestan Zahedan - Persian Gulf Highway - Imam Khomeini Mosque - Ali Bin Abi Talib Hospital
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743111
Approval date
2020-01-04, 1398/10/14
Ethics committee reference number
IR.ZAUMS.REC.1398.347
Health conditions studied
1
Description of health condition studied
Hypercalciuria in patients with kidney stones
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Increased urinary calcium level
Timepoint
24-hour urine calcium measurement at baseline (before intervention) and 3 months after intervention
Method of measurement
Laboratory measurement
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: People with kidney stones who have vitamin D levels below 30 ng / ml are prescribed oral vitamin D 50,000 units weekly for up For each patient, training sessions are held before and after the intervention, and in this study, the product of Zahravi Company is used.to 8 weeks.
Category
Treatment - Drugs
2
Description
Control group: People with kidney stones who have vitamin D levels below 30 ng / ml are given weekly placebo for up to 8 weeks.For each patient, training sessions are held before and after the intervention, and in this study, the product of Zahravi Company is used.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Ali ebn Abitaleb Hospital
Full name of responsible person
Ali Alidadi
Street address
Ali ebn AbiTaleb Hospital ., Persian Gulf Highway
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743111
Phone
+98 54 3329 5575
Email
Alihos@zaums.ac.ir
Web page address
https://Alihos.zaums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Dr. Nourmohammad Bakhshani - Deputy of Research and Technology of the University
Street address
Ali Bin Abi Talib Hospital ., Persian Gulf Highway ., Zahedan town ., sistan and Baluchestan province
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743111
Phone
+98 54 3329 5570
Email
Alihos@zaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zahedan 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
Zahedan University of Medical Sciences
Full name of responsible person
elham javadian
Position
Internal medicine assistant
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Ali Bin Abi Talib Hospital ., Persian Gulf Highway ., Zahedan town ., sistan and Baluchestan province
City
zahedan
Province
Sistan and Baluchestan province
Postal code
9816743111
Phone
+98 54 3329 5575
Email
elham.javadian1396@zaums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
elham javadian
Position
Internal medicine assistant
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Ali Bin Abi Talib Hospital ., Persian Gulf Highway ., Zahedan town ., sistan and Baluchestan province
City
Zahedan
Province
Sistan and Balochestan
Postal code
9816743111
Phone
05433295570
Email
elham.javadian1396@zaums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
elham javadian
Position
Internal medicine assistant
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Ali Bin Abi Talib Hospital ., Persian Gulf Highway ., Zahedan town ., sistan and Baluchestan province
City
zahedan
Province
Sistan and Balochestan
Postal code
9816743111
Phone
05433295570
Email
elham.javadian1396@zaums.ac.ir
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 whole potential data is unpublished after being unidentifiable
When the data will become available and for how long
Start the access period 6 months after printing the results
To whom data/document is available
Only available to scholars working in academic and academic institutions
Under which criteria data/document could be used
Use of study data is permitted for any use by researchers working in academic and scientific institutions
From where data/document is obtainable
Ali ebn Abitalib Hospital, Zahedan, Department of intral Deputy of Research of Zahedan University of Medical Sciences, Faculty of Medicine Dr. Ali Alidadi, professor of the thesis, telephone number 09120621590
What processes are involved for a request to access data/document
It takes about 1 month from the request of the applicant to access data files or time documentation