Determination of the relationship between fgf23 level and serum iron and ferritin level before and after iron supplement injection in hemodialysis patients
Design
Study Type: Clinical Trial (Pre and Post Study)
Case study: All hemodialytic patients
Sample size: The sample size is estimated to be 45 according to the statistical formula obtained from the same study.
Settings and conduct
Methods: All patients with hemodialysis at the center of dialysis of Ali ibn Abi Taleb Hospitals will enter into the study. The level of 23FGF, serum iron and ferritin, and the transferrin saturation percentage of patients will be assessed and the baseline level will be determined.
Then All patients will receive 100 mg of an equal dose of 10 mg each dose of dialysis 10 times in a similar manner. In the end, The above test levels will be re-evaluated.
Participants/Inclusion and exclusion criteria
Inclusion criteria :
-All patients who have completed their dialysis for at least 3 months.
-All patients aged18 to70years.
-All patients have ferritin less than200and transferrin saturation less than20%.
Exclusion criteria:
- patients dissatisfaction
-Malignancy
-Parathyroidectomy
-Infection
-Recent consumption of corticosteroid
Intervention groups
Intervention group: All those who are eligible for the study will be treated with 100 mg of injectable iron (Venofer) with dialysis 10 times for 3 months.
Main outcome variables
Determination of FGF23 levels
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190506043488N1
Registration date:2019-12-27, 1398/10/06
Registration timing:registered_while_recruiting
Last update:2019-12-27, 1398/10/06
Update count:0
Registration date
2019-12-27, 1398/10/06
Registrant information
Name
Foroogh Asli
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 54 3329 5630
Email address
foroogha66@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-23, 1398/07/01
Expected recruitment end date
2020-03-19, 1398/12/29
Actual recruitment start date
2019-10-23, 1398/08/01
Actual recruitment end date
2020-04-20, 1399/02/01
Trial completion date
2020-09-21, 1399/06/31
Scientific title
The effect of injectable iron supplementation on FGF23 levels in hemodialysis patients
Public title
The effect of intravenous iron on fgf23 and iron profile
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria:
All patients with hemodialysis who have completed their dialysis for at least 3 months.
All patients with hemodialysis aged 18 to 70 years.
All patients with hemodialysis have ferritin less than 200 and transferin saturation less than 20 %.
Exclusion criteria:
Dissatisfaction patients to enter the study
transfusion
Malignancy
Parathyroidectomy
Infection of any type ( catheter infection, UTI,....)
Recent consumption of corticosteroid
Active bleeding
Advanced heart disease
liver disease
Age
From 18 years old to 70 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
45
Actual sample size reached:
45
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 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
2019-09-21, 1398/06/30
Ethics committee reference number
IR.ZAUMS.REC.1398.237
Health conditions studied
1
Description of health condition studied
Iron deficiency anemia in hemodialysis patients
ICD-10 code
N18.5
ICD-10 code description
Chronic kidney disease, stage 5
Primary outcomes
1
Description
Fibroblast growth factor 23 level
Timepoint
Measurement of Fibroblast growth factor 23 level at the beginning of the study (before intervention) and 3 months after intervention
Method of measurement
Laboratory measurement
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Hemodialysis patients who meet the inclusion criteria will receive 100 mg of intravenous iron (venoffer) supplement 10 times during 3 months after each dialysis.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ali ibn Abi taleb Hospital
Full name of responsible person
Ali Alidadi
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 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 5575
Email
Alihos@zaums.ac.ir
Web page address
https://Alihos.zaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Deputy of Research and Technology of Zahedan University of Medical Science
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
Foroogh Asli
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Sistan and Baluchestan University of Zahedan, University of Milan 5th University
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743111
Phone
+98 54 3329 5575
Email
forooghasli1366@zaums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Foroogh Asli
Position
Internal medicine assistant
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Sistan and Baluchestan University of Zahedan, University of Milan 5th University
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743111
Phone
+98 54 3329 5575
Email
forooghasli1366@zaums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Foroogh Asli
Position
Internal medicine assistant
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Daneshgah 5 Alley ,Daneshgah street ,Zahedan town , Sistan and Baluchestan province
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743111
Phone
+98 54 3329 5575
Email
forooghasli1366@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 Hemodialysis
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