Comparison of Sevelamer and Calcium carbonat on magnesium serum level in hemodialyzed patients referring to hemodialysis center of Kosar hospital in Semnan in 2018-9
comparison of sevelamer and calcium carbonate on magnesium serum level in hemodialyzed patients
Design
Two arm parallel group randomised trial with non blinded postoperative care and outcome assessment
Settings and conduct
Randomized trial in hemodialyzed patients referring to hemodialysis center of Kosar hospital in Semnan in 2018
Participants/Inclusion and exclusion criteria
Entrance: Patients who ESRD and treated with hemodialysis 3 times in week in 3 months and have phosphorus level upper than 5.4 mg/dl
Exit: Patients who have associated diseases e.g acute heart or liver diseases; history of recent diarrhea; history of Ileostomia or colostomia; history of major GI surgery; patients who treated with cyclosporin, aminoglycosids, amphotrysin B, furasemid, Thiazids or Proton pomp inhibitors; patients who have hypercalcemia
Intervention groups
Comparison of sevelamer and calcium carbonate
Main outcome variables
Magnesium serum level
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180831040912N1
Registration date:2018-10-25, 1397/08/03
Registration timing:registered_while_recruiting
Last update:2018-10-25, 1397/08/03
Update count:0
Registration date
2018-10-25, 1397/08/03
Registrant information
Name
elahe jandaghi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 23 3334 1157
Email address
dr.ejandaghi@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-10-07, 1397/07/15
Expected recruitment end date
2019-01-05, 1397/10/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Sevelamer and Calcium carbonat on magnesium serum level in hemodialyzed patients referring to hemodialysis center of Kosar hospital in Semnan in 2018-9
Public title
Comparison of Sevelamer and Calcium carbonat on magnesium serum level in hemodialyzed patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
ESRD patients who need hemodialysis 3 times week in 3 months
Serum Phosphorus level >5.4mg/dl
Exclusion criteria:
Those who did not complete the consent
Associated disease e.g acute heart & liver diseases
History of recent Diarrhea
History of Ileostomia or colostomia
History of major GI surgery
Patients who treated with Cyclosporin, Aminoglycosids, Amphotricin B, Furasemid and Thiazids
Patients who treated with PPI
Patients who had hypercalcemia
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Random sequence
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
Ethics committee of Semnan University of Medical Sciences
Street address
Kosar Hospital, Basidj Blvd.
City
semnan
Province
Semnan
Postal code
3514618653
Approval date
2018-02-13, 1396/11/24
Ethics committee reference number
IR.SEMUMS.REC.1397.076
Health conditions studied
1
Description of health condition studied
ESRD patients who hemodialyzed
ICD-10 code
N18.6
ICD-10 code description
End stage renal disease
Primary outcomes
1
Description
Magnesium serum level
Timepoint
Before study and 3 months after treatment
Method of measurement
Photometric method
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Sevelamer with brand name Foseal manufactured in Emcure pharmaceutical LTD. India 800 mg start with one tablet daily up to 3 tablet depend on calcium and phosphorus level
Category
Treatment - Drugs
2
Description
Intervention group: calcium carbonate manufactured in Saponin pharmaceutical Co.. I. R.Iran 500 mg start with one tablet daily up to 3 tablet depend on calcium and phosphorus level
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Kosar hospital
Full name of responsible person
Elahe Jandaghi
Street address
Kosar hospital, Basidj Blvd.
City
Semnan
Province
Semnan
Postal code
3519899951
Phone
+98 23 3142 2410
Email
dr.ejandaghi@gmail.com
Web page address
http://kosarhos.semums.ac.ir/index.jsp
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Parviz Kokhaie
Street address
Semnan University of Medical Sciences, Basidj Blvd.
City
Semnan
Province
Semnan
Postal code
3519899951
Phone
+98 23 3341 0221
Email
rds@semums.ac.ir
Web page address
http://rtvc.semums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan 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
Semnan University of Medical Sciences
Full name of responsible person
Elahe Jandaghi
Position
Assisstant professor
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Kosar hospital, Basidj Blvd.
City
Semnan
Province
Semnan
Postal code
3819899951
Phone
+98 23 3142 2410
Email
dr.ejandaghi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Elahe Jandaghi
Position
Assisstant professor
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Kosar hospital, Basidj Blvd.
City
Semnan
Province
Semnan
Postal code
3819899951
Phone
+98 23 3142 2410
Email
dr.ejandaghi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Elahe Jandaghi
Position
Assisstant professor
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Kosar hospital, Basidj Blvd.
City
Semnan
Province
Semnan
Postal code
3819899951
Phone
+98 23 3142 2410
Email
dr.ejandaghi@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available