Detection of serum level changes of calcium / phosphate /parathyroid hormone in two groups of study (calciteriol and cinacalcate)
Design
Randomized clinical trial (Phase 3) of two arms, parallel with Cinacalcate and Calciteriol groups and double blind with 30-person groups
Settings and conduct
This randomized double-blind clinical trial study was performed to evaluate the parameters of calcium, phosphorus and parathyroid hormone (PTH) before and 8 weeks after intervention in Hajar hospital of Shahrekord. Patients were divided into two groups of 30 persons of Cinacalcate and Calciteriol. Patients in this study were unaware of placement in the Calcitriol and Cinacalcet groups. The statistical analysis of the groups was performed based on the code and the statistician is blind.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Consent to participate in the study, Having end-stage renal disease, Patients undergoing hemodialysis. Non-inclusion criteria: Parathyroid hormone less than 300 pg / ml
Calcium higher than 10 mg / dl
Intervention groups
Group 1 receive Cinacalcate and group 2 receive Calciteriol
Main outcome variables
Calcium/phophate/Parathyroid hormone (PTH)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190702044076N1
Registration date:2019-09-21, 1398/06/30
Registration timing:retrospective
Last update:2019-09-21, 1398/06/30
Update count:0
Registration date
2019-09-21, 1398/06/30
Registrant information
Name
Faranak sadat Filsous
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3778 8907
Email address
hamidnasri@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-07-03, 1397/04/12
Expected recruitment end date
2019-07-03, 1398/04/12
Actual recruitment start date
2018-07-03, 1397/04/12
Actual recruitment end date
2019-07-03, 1398/04/12
Trial completion date
2019-08-03, 1398/05/12
Scientific title
A Comparative Study on the Effect of Calcitriol and Cinacalcet on Hyperparathyroidism in ESRD Patients
Public title
Effect of Calciterol and Cinacalcate on hyperparathyroidism
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Consent to participate in the study
Having end-stage renal disease
Patients undergoing hemodialysis
Exclusion criteria:
Parathyroid hormone less than 300 pg / ml
Calcium higher than 10 mg / dl
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
60
Actual sample size reached:
60
Randomization (investigator's opinion)
Randomized
Randomization description
First, the participants were given two-digit codes from 01 to 60. Then, using the website www.Randomization.com, the statistical consultant provided two sets of codes, the first set assigned as the Calcitriol group and the second, Cinacalcet group.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients in this study were unaware of placement in the Calcitriol and Cinacalcet groups. The statistical analysis of the groups was performed based on the code and the statistician is blind.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shahrekord university
Street address
Num 21/shahid yar mohammadi alley/Bagh ziar Blve
City
Esfahan
Province
Isfehan
Postal code
8177774564
Approval date
2018-04-22, 1397/02/02
Ethics committee reference number
IR.SKUMS.REC.1397.026
Health conditions studied
1
Description of health condition studied
Hyperparathyroidism
ICD-10 code
E21
ICD-10 code description
Hyperparathyroidism and other disorders of parathyroid gland
Primary outcomes
1
Description
Calcium
Timepoint
Before the intervention and 8 weeks after the intervention
Method of measurement
Serum levels of blood sample
2
Description
Phosphate
Timepoint
Before the intervention and 8 weeks after the intervention
Method of measurement
Serum levels of blood sample
3
Description
Parathyroid hormone
Timepoint
Before the intervention and 8 weeks after the intervention
Method of measurement
Serum levels of blood sample
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: The group receiving Cinaaclate (AMGEN pharmaceutical company of Netherland ) receives 30 mg daily. The ultimate target of this group is the PTH level between 150 Pg / ml and 300 Pg / ml. The dose can be increased to 90 mg daily or three 30 mg tablets daily if elevated. This treatment is continued for up to 8 weeks after starting the study and then the levels of phosphate, calcium and parathyroid hormone are measured.
Category
Treatment - Drugs
2
Description
Intervention group 2: The group receiving Calcitriol (Zahravi Pharmaceutical Company of Iran) receives 0.5-1.5 mg daily. The ultimate target of this group is the PTH level between 300 Pg / ml and 600 Pg / ml. The dose may be increased to 1.5–3 mg daily if elevated. This treatment is continued for up to 8 weeks after starting the study and then the levels of phosphate, calcium and parathyroid hormone are measured.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Hajar hospital in Shahrekord
Full name of responsible person
Faranak Sadat Filsouf
Street address
Parastar street
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8813833435
Phone
+98 38 3222 5505
Email
Hajar-Hospital@skums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Saeed Mardani
Street address
Farabi street
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815716191
Phone
+98 38 3333 4818
Email
s-mardani@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahre-kord University of Medical Sciences
Proportion provided by this source
70
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
Shahre-kord University of Medical Sciences
Full name of responsible person
Faranak Sadat Filsouf
Position
Medical doctor
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Bagh Ziar
City
Isfahan
Province
Isfehan
Postal code
8177775364
Phone
+98 31 3778 8907
Email
Frankfaranak@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Faranak Sadat Filsouf
Position
Medical doctor
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Bagh Ziar street
City
Isfahan
Province
Isfehan
Postal code
788885764
Phone
+98 31 3778 8907
Email
Frankfaranak@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Saeed Mardani
Position
Internist
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Farabi
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
881576191
Phone
+98 38 3334 8418
Email
s-mardani@yahoo.om
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
privacy
Study Protocol
Undecided - It is not yet known if there will be 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
-
When the data will become available and for how long
-
To whom data/document is available
-
Under which criteria data/document could be used
-
From where data/document is obtainable
-
What processes are involved for a request to access data/document