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Oral Cholecalciferoleffests on proteinuria and urinary TGF-β1and urinary MCP-1in non-diabetic nephropathy patients on established renin–angiotensin–aldosterone system inhibition

Protocol summary

Study aim
Determining the effect of oral vitamin D on urinary protein, TGF-β1, and urinary MCP-1 levels in non-diabetic renal patients
Design
A quasi-clinical trial, without a control group, without randomization, and without blinding, will be conducted in a clinical phase 2-3 on 40 patients.
Settings and conduct
This study will be conducted on chronic kidney disease patients referred to the urology department of Shariati Hospital, Isfahan. Before the intervention, urinary levels of protein, TGF-β1, and MCP-1 will be measured. Then, patients will be given oral vitamin D at a dose of 50,000 IU (one capsule weekly) for 4 months. At the following 2-month and 4-month time points, urinary levels of protein, TGF-β1, and MCP-1 will be measured and compared with baseline values.
Participants/Inclusion and exclusion criteria
Participants in the study will be non-diabetic kidney patients. Age over 18 years, body mass index less than 30, and no diabetes were included in the study, and vitamin D levels less than 20 ng/mL, a history of immunosuppressive drugs, and hypercalcemia, kidney stones, and arteriosclerosis were excluded from the study.
Intervention groups
The intervention group will receive 50,000 IU (one capsule weekly) of Cholecalciferol (oral vitamin D) for 4 months.
Main outcome variables
The main outcome included changes in urinary protein, TGF-β1, and MCP-1.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20151123025202N43
Registration date: 2024-11-28, 1403/09/08
Registration timing: prospective

Last update: 2024-11-28, 1403/09/08
Update count: 0
Registration date
2024-11-28, 1403/09/08
Registrant information
Name
Abbas Moradi
Name of organization / entity
Hamedan University of Medical Of Science
Country
Iran (Islamic Republic of)
Phone
+98 81 3838 0097
Email address
a.moradi@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-12-05, 1403/09/15
Expected recruitment end date
2025-07-06, 1404/04/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Oral Cholecalciferoleffests on proteinuria and urinary TGF-β1and urinary MCP-1in non-diabetic nephropathy patients on established renin–angiotensin–aldosterone system inhibition
Public title
،he effect of vitamin D on kidney function in non-diabetic nephropathy patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having proteinuria, persistent (at least 3 months) excretion daily proteinuria more than 150 mg Age >18 years BMI≥30 kg/m2
Exclusion criteria:
Having diabetes Vitamin D level less than 20 ng/ml Receiving immunosuppressive drugs within the past 3 months Hypercalcemia, kidney stones, and arteriosclerosis
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 40
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 IsfahanUniversity of Medical Sciences
Street address
Hezar Jrip
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2023-12-27, 1402/10/06
Ethics committee reference number
IR.MUI.MED.REC.1402.360

Health conditions studied

1

Description of health condition studied
Chronic kidney disease
ICD-10 code
N18
ICD-10 code description
Chronic kidney disease (CKD)

Primary outcomes

1

Description
Changes in urine protein
Timepoint
Before starting treatment, at the end of the second month, and at the end of the fourth month after starting treatment
Method of measurement
24-hour urine protein test

2

Description
Urinary TGF-β1 changes
Timepoint
Before starting treatment, at the end of the second month, and at the end of the fourth month after starting treatment
Method of measurement
Urine test

3

Description
Urinary MCP-1 changes
Timepoint
Before starting treatment, at the end of the second month, and at the end of the fourth month after starting treatment
Method of measurement
Urine test

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: They will receive 50,000 IU (one capsule per week) of Cholecalciferol (oral vitamin D) for 4 months.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Khorshid Medical Edicational Complex
Full name of responsible person
Dr. Mojgan Mokhtari
Street address
Ostandari
City
Isfahan
Province
Isfehan
Postal code
8145833117
Phone
+98 31 3222 2127
Email
nour@mui.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Gholamreza Asgari
Street address
Hezarjrib
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 8138
Email
research@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Hamedan University of Medical Sciences
Full name of responsible person
Abbas Moradi
Position
Coach
Latest degree
Master
Other areas of specialty/work
Epidemiology
Street address
Shahid Fahmideh
City
Hamadan
Province
Hamadan
Postal code
6517838736
Phone
+98 81 3838 0572
Fax
+98 81 3838 0208
Email
a.moradi@umsha.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mojgan Mokhtari
Position
Associated Profesor
Latest degree
Specialist
Other areas of specialty/work
Pathology
Street address
Hezarjrb
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 8597
Email
mokhtari.ptlgy@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Abbas Moradi
Position
Coach
Latest degree
Master
Other areas of specialty/work
Epidemiology
Street address
Shahid Fahmideh
City
Hamadan
Province
Hamadan
Postal code
6517838736
Phone
+98 81 3838 0572
Fax
+98 81 3838 0208
Email
a.moradi@umsha.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
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
All data can be shared except for authors names
When the data will become available and for how long
From 2026 onwards it is permissible
To whom data/document is available
Clinical professionals and Researchers in all fields
Under which criteria data/document could be used
For treatment of patients and develop research and science
From where data/document is obtainable
Correspond to the email address of the scientific responsible for the study
What processes are involved for a request to access data/document
Send and receive email
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